Substance UseNCT02383225
Culturally Grounded Early Substance Use Prevention for American Indian Families
A study testing Lakota Language enhancement, Facebook Supplement and Substance Use Resistance Skills in people with Substance Use, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study involves adaptation, implementation, and rigorous evaluation of a family-based program designed to prevent early initiation of substance use on a Northern Plains Indian reservation. Read more about this study
- Who is it for?
- Ages 10 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Lakota Language enhancement, Facebook Supplement and Substance Use Resistance Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 449 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2013to 4 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth aged 10-14 years and their families, with connection to the South Dakota Indian Reservation where the study is being conducted. Families may include parents, extended family, guardians, and others living in the household.
Who cannot join
- Individuals without a child in the family aged 10-14 will not be allowed to participate.
- Youth who are not between 10 and 14 years of age will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This study involves adaptation, implementation, and rigorous evaluation of a family-based program designed to prevent early initiation of substance use on a Northern Plains Indian reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa Strengthening Families Program for Parents and Youth 10-14. Youth and their parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre- and post-intervention surveys assessing a variety of risk and protective factors and youth outcomes. The evaluation design will allow the assessment of the effectiveness of different components within the program.
Read the detailed description
Feasibility Pilot
A feasibility pilot for the Thiwáhe Gluwáš'akapi (TG) program will be conducted in the Spring of 2015. In the pilot, the intervention will be delivered to two groups of youth and families and the implementation process will be carefully evaluated to determine what works well and where further adaptation of the intervention or the study procedures may be necessary. Particular attention will be paid to retention of families and, if possible, any who drop out will be interviewed to understand barriers to participation.
As with the intervention evaluation itself (see below) youth aged 10-14 will be recruited to participate, along with their parents and/or other adults (up to 3 adults per child) who are actively involved in raising them (e.g., grandparents, aunts, uncles). Pilot groups will be conducted in each of two different communities on the reservation.
Once the feasibility pilot is complete, the intervention will be finalized for efficacy evaluation. Tasks for this phase will include refining the manual for the intervention and further developing training materials for interventionists.
Implementation/Component Evaluation
The formal evaluation of TG will begin in the fall of 2015 and will utilize the principles of Multiphase Optimization Strategy (MOST; Collins et al., 2009) for intervention development and a fractional factorial design to evaluate the relative effectiveness of different components within the intervention. Three components will be evaluated: (1) A Lakota language enhancement (Lakota), (2) a Facebook social media enhancement (FB), and (3) substance use resistance skill content (SU). A total of 24 intervention groups will be randomly assigned to one of 4 MOST design conditions, with the content of each condition determined using SAS PROC FACTEX, as recommended by Collins, et al, 2009. All 4 conditions will consist of the basic TG program, each supplemented by one or more of 3 components designated above: Condition A will include the substance use resistance content (SU; no Lakota or FB); Condition B will include the FB social media supplement (FB; no Lakota or SU); Condition C will include the Lakota language enhancement (Lakota; no FB or SU); and Condition D will include all three components (Lakota + FB + SU).
A cumulative evidence design will be utilized, with the intervention implemented in 5 cohorts across 3 years. The intervention will be delivered to 4 groups (8 families each) in Cohort 1 in the fall of 2015. Additional cohorts will receive the intervention each fall and spring through 2017 as follows: Cohort 2, Spring 2016, 4 groups; Cohort 3, Fall 2016, 6 groups; Cohort 4, Spring 2017, 6 groups; and Cohort 5, Fall 2017, 4 groups. Thus, by the end of 2017, 24 intervention groups (each 8 families, total of 192 families) will have participated in the TG program. Cohorts will be randomly assigned to the 4 MOST design conditions in order to control for potential order of implementation effects.
Power analysis
Power analyses suggest that this design will result in adequate power (>.80) to detect a small effect (d=.15) with 48 families per condition; for the 4 conditions in the design, this will require a total of 192 families (not including 16 pilot families). TG, following Iowa Strengthening Families Program (ISFP) recommendations, will be delivered in family groups of 8 families each; thus, in order to involve 192 families, we plan a total of 24 intervention groups, with 6 in each the 4 experimental conditions. Each component targeted for evaluation will be implemented in 2 of the 4 conditions (see conditions A-B above), and estimates of each effect will thus be based on marginal Ns of 96 families. As is standard with MOST designs, there will not be a no-intervention control group nor will there be a group that receives every component. While this is a different approach than an randomized controlled trial (RCT) design, it is a rigorous and optimal approach for identifying the most effective components to include in an intervention. The intervention created using this process will be ready for a standard RCT evaluation, and more likely to be proven effective there.
Implementation evaluation
Fidelity across implementations will be ensured by using a detailed manual of procedures, providing extensive training for interventionists, and using fidelity logs to asses delivery of key session components. The intervention director, a clinical psychologist, will observe sessions periodically and verify the extent to which implementation is occurring with fidelity to the TG program manual.
Efficacy evaluation
The primary impetus for the development and implementation of the TG program is the desire to reduce risk for substance abuse problems among American Indian adolescents by preventing early initiation of substance use. Assessment of the success of the TG program components will hinge on observed impacts on substance use initiation and on the putative mediators of parental self-efficacy, strengthened family relationships, and cultural knowledge and values. Given the short timeline of the outcome evaluations (limited to 6 months post-intervention), effects on mediators are anticipated to stronger than distal effects on behavioral outcomes.
Measures
Measures used to assess study outcomes draw heavily from the investigators' previous research with young American Indian adolescents and their parents, and from previous evaluations of the Iowa Strengthening Families Program for Parents and Youth 10-14. Two instruments will be used to assess an array of outcomes expected to be affected by the TG intervention, along with demographic data: a Parent Survey (for parents and other caregivers participating in the TG program with youth), and a Youth Survey. Both the Parent Survey and Youth Survey will be administered electronically, using tablet computers connected to the Internet, with data uploaded directly. In addition, a Social Network Survey will be administered (either on an electronic tablet or on paper) to participating parents/caregivers; this survey is designed to assess the strength of the connections among participants in the program, both before and after participation in the program. A small number of participants (3-4) in each group assigned to the FaceBook condition will be asked to participate in Exit Interviews (by phone) to ascertain their use of and response to the social media messages provided between TG sessions. Data will also be captured from Facebook, including page visits, posts, and responses to online quizzes. Finally, participants will be asked to complete a Program Evaluation Form (Parent or Youth versions, on paper) at their last TG session, to provide feedback on the program and facilitators.
Data Collection Schedule
Time 1 - One week prior to the first TG session: Parent and Youth surveys (all participants).
Time 2 - First TG session: Social Network Surveys (adults).
Time 3 - One week after last TG session: Parent and Youth Surveys (all participants); Social Network Survey (adults)
Time 4 - Within two weeks after final TG session: FaceBook Exit Interviews (3-4 adult participants in each condition including the FaceBook supplement)
Time 5 - Approximately 6 months after the last TG session: Parent and Youth Surveys (all participants in the first two intervention cohorts)
Analyses
The simplest analyses for the evaluation of the TG program, using the MOST design, will involve analysis of variance (ANOVA), using the fractional factorial design described above, comparing post-intervention values (Time 3 and Time 5) on both mediators and outcomes across conditions (assuming that randomization across conditions will result in roughly equivalent pre-intervention values). Repeated measures ANOVA will also be performed, including both pre- and post-intervention measures, looking for interactions between time and condition. Finally, multivariate ANOVAs will be estimated for groups of outcome variables, to examine patterns of effects across outcomes. For all analyses, the focus will be on effect sizes (rather than significance tests and p values) to compare effect sizes across components to guide decisions about what should be retained in the optimized TG intervention. As noted above, standard errors will be adjusted to account for intraclass correlations and clustering of families within intervention groups. Analyses of the Social Network Measure will focus on assessing density and cohesion at the network level, to address two primary questions: First, do network characteristics at the beginning of the program (pre-existing relationships within intervention groups) modify the effect of the TG intervention within those groups and, second, do network characteristics change over the course of the TG intervention as new relationships are formed and existing relationships changed. Analyses will be conducted using UCINET or similar social network analysis software. Analyses of the Facebook data will be primarily descriptive, examining the frequency with which participants engage with the Facebook page for their TG group by posting comments, or responding to polls or quizzes. Exploratory analyses may be used to examine correlations between group rates of Facebook use and group-level outcomes, such as increased cohesion as measured by the Social Network Analysis. Analyses of Facebook Exit Interviews will be primarily notes-based content analysis and will involve three major stages of analysis: open coding, axial coding, and selective coding.
- Conditions
- Substance Use
- Being tested
- Lakota Language enhancement, Facebook Supplement, Substance Use Resistance Skills
- Keywords
- American Indian, Adolescent, Prevention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lakota Language enhancementBehavioural
This intervention component includes more extensive adaptation for Lakota families, focusing on use of Lakota language specifically around relationship/kinship terms. Study arms without this component will include the same adapted intervention but with use of English language rather than Lakota.
Facebook SupplementBehavioural
This intervention component includes a social media supplement to engage families outside of weekly intervention sessions and will include postings and polls for participating parents/other caregivers to complete between sessions.
Substance Use Resistance SkillsBehavioural
This intervention component consists of the original substance use resistance skills training from the Iowa Strengthening Families Program for Parents and Youth 10-14; arms without this component will include a session on healthy eating and exercise (attention control).
| Study group | Role | What they receive |
|---|---|---|
| Condition A | Experimental | Substance use resistance skills; no Lakota language enhancement, no FaceBook supplement Receives: Behavioral: Substance Use Resistance Skills |
| Condition B | Experimental | FaceBook supplement; no Lakota language enhancement; no Substance Use resistance skills Receives: Behavioral: Facebook Supplement |
| Condition C | Experimental | Lakota language enhancement; no FaceBook supplement; no Substance Use resistance skills Receives: Behavioral: Lakota Language enhancement |
| Condition D | Experimental | Lakota language enhancement; FaceBook supplement; Substance Use resistance skills Receives: Behavioral: Lakota Language enhancement; Behavioral: Facebook Supplement; Behavioral: Substance Use Resistance Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: Baseline (1 week before program start)
Youth lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: Post-intervention (1 week after program conclusion)
Youth lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: Follow-up (6 months after program conclusion)
Youth past-month alcohol use
Mean frequency of past month alcohol use
Measured: Baseline (1 week before program start)
Youth past-month alcohol use
Mean frequency of past month alcohol use
Measured: Post-intervention (1 week after program conclusion)
Youth past-month alcohol use
Mean frequency of past month alcohol use
Measured: Follow-up (6 months after program conclusion)
Youth maximum alcohol use in past month
Mean maximum quantity of past month alcohol consumption
Measured: Baseline (1 week before program start)
Youth maximum alcohol use in past month
Mean maximum quantity of past month alcohol consumption
Measured: Post-intervention (1 week after program conclusion)
Youth maximum alcohol use in past month
Mean maximum quantity of past month alcohol consumption
Measured: Follow-up (6 months after program conclusion)
Youth age of first alcohol use
Mean age of first alcohol use
Measured: Baseline (1 week before program start)
Youth age of first alcohol use
Mean age of first alcohol use
Measured: Post-intervention (1 week after program conclusion)
Youth age of first alcohol use
Mean age of first alcohol use
Measured: Follow-up (6 months after program conclusion)
Youth lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: Baseline (1 week before program start)
Youth lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: Post-intervention (1 week after program conclusion)
Youth lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: Follow-up (6 months after program conclusion)
Youth past-month cigarette use
Mean frequency of past month cigarette use
Measured: Baseline (1 week before program start)
Youth past-month cigarette use
Mean frequency of past month cigarette use
Measured: Post-intervention (1 week after program conclusion)
Youth past-month cigarette use
Mean frequency of past month cigarette use
Measured: Follow-up (6 months after program conclusion)
Youth age of first cigarette use
Mean age of first cigarette use
Measured: Baseline (1 week before program start)
Youth age of first cigarette use
Mean age of first cigarette use
Measured: Post-intervention (1 week after program conclusion)
Youth age of first cigarette use
Mean frequency of past month cigarette use
Measured: Follow-up (6 months after program conclusion)
Youth prevalence of smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: Baseline (1 week before program start)
Youth prevalence of smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: Post-intervention (1 week after program conclusion)
Youth prevalence of smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: Follow-up (6 months after program conclusion)
Youth frequency of past-month smokeless tobacco use
Mean frequency of past month smokeless tobacco use
Measured: Baseline (1 week before program start)
Youth frequency of past-month smokeless tobacco use
Mean frequency of past month smokeless tobacco use
Measured: Post-intervention (1 week after program conclusion)
Youth frequency of past-month smokeless tobacco use
Mean frequency of past month smokeless tobacco use
Measured: Follow-up (6 months after program conclusion)
Youth age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: Baseline (1 week before program start)
Youth age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: Post-intervention (1 week after program conclusion)
Youth age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: Follow-up (6 months after program conclusion)
Youth lifetime prevalence of e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: Baseline (1 week before program start)
Youth lifetime prevalence of e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: Post-intervention (1 week after program conclusion)
Youth lifetime prevalence of e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: Follow-up (6 months after program conclusion)
Youth past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: Baseline (1 week before program start)
Youth past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: Post-intervention (1 week after program conclusion)
Youth past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: Follow-up (6 months after program conclusion)
Youth lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: Baseline (1 week before program start)
Youth lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: Post-intervention (1 week after program conclusion)
Youth lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: Follow-up (6 months after program conclusion)
Youth past-month marijuana use
Mean frequency of past month marijuana use
Measured: Baseline (1 week before program start)
Youth past-month marijuana use
Mean frequency of past month marijuana use
Measured: Post-intervention (1 week after program conclusion)
Youth past-month marijuana use
Mean frequency of past month marijuana us
Measured: Follow-up (6 months after program conclusion)
Youth age of first marijuana use
Mean age of first marijuana use
Measured: Baseline (1 week before program start)
Youth age of first marijuana use
Mean age of first marijuana use
Measured: Post-intervention (1 week after program conclusion)
Youth age of first marijuana use
Mean age of first marijuana use
Measured: Follow-up (6 months after program conclusion)
Youth lifetime prevalence of huffing glue/gas
Lifetime prevalence of huffing
Measured: Baseline (1 week before program start)
Youth lifetime prevalence of huffing glue/gas
Lifetime prevalence of huffing
Measured: Post-intervention (1 week after program conclusion)
Youth lifetime prevalence of huffing glue/gas
Lifetime prevalence of huffing
Measured: Follow-up (6 months after program conclusion)
Youth past-month huffing
Mean frequency of past month huffing
Measured: Baseline (1 week before program start)
Youth past-month huffing
Mean frequency of past month huffing
Measured: Post-intervention (1 week after program conclusion)
Youth past-month huffing
Mean frequency of past month huffing
Measured: Follow-up (6 months after program conclusion)
Youth age of first huffing
Mean age of first huffing
Measured: Baseline (1 week before program start)
Youth age of first huffing
Mean age of first huffing
Measured: Post-intervention (1 week after program conclusion)
Youth age of first huffing
Mean age of first huffing
Measured: Follow-up (6 months after program conclusion)
Secondary outcomes (275)
Youth perceived consistency of parental discipline practices
Mean perceived consistency of parental discipline practices score
Measured: baseline (1 week before program start)
Youth perceived consistency of parental discipline practices
Mean perceived consistency of parental discipline practices score
Measured: post-intervention (1 week after program conclusion)
Youth perceived consistency of parental discipline practices
Mean perceived consistency of parental discipline practices score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental standard setting
Mean perceived parental standard setting score
Measured: baseline (1 week before program start)
Youth perceived parental standard setting
Mean perceived parental standard setting score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental standard setting
Mean perceived parental standard setting score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental monitoring
Mean perceived parental monitoring score
Measured: baseline (1 week before program start)
Youth perceived parental monitoring
Mean perceived parental monitoring score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental monitoring
Mean perceived parental monitoring score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental positive affect
Mean perceived parental positive affect score
Measured: baseline (1 week before program start)
Youth perceived parental positive affect
Mean perceived parental positive affect score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental positive affect
Mean perceived parental positive affect score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental approval
Mean perceived parental approval score
Measured: baseline (1 week before program start)
Youth perceived parental approval
Mean perceived parental approval score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental approval
Mean perceived parental approval score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental negative affect
Mean perceived parental negative affect score
Measured: baseline (1 week before program start)
Youth perceived parental negative affect
Mean perceived parental negative affect score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental negative affect
Mean perceived parental negative affect score
Measured: follow-up (6 months after program conclusion)
Youth perceived parent-child communication
Mean perceived parent-child communication score
Measured: baseline (1 week before program start)
Youth perceived parent-child communication
Mean perceived parent-child communication score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parent-child communication
Mean perceived parent-child communication score
Measured: follow-up (6 months after program conclusion)
Youth perceived parent-child communication about alcohol and drugs
Mean perceived parent-child communication about alcohol and drugs score
Measured: baseline (1 week before program start)
Youth perceived parent-child communication about alcohol and drugs
Mean perceived parent-child communication about alcohol and drugs score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parent-child communication about alcohol and drugs
Mean perceived parent-child communication about alcohol and drugs score
Measured: follow-up (6 months after program conclusion)
Youth perceived enforcement of family rules
Mean perceived enforcement of family rules score
Measured: baseline (1 week before program start)
Youth perceived enforcement of family rules
Mean perceived enforcement of family rules score
Measured: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Youth perceived enforcement of family rules
Mean perceived enforcement of family rules score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental autonomy support
Mean perceived parental autonomy support score
Measured: baseline (1 week before program start)
Youth perceived parental autonomy support
Mean perceived parental autonomy support score
Measured: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Youth perceived parental autonomy support
Mean perceived parental autonomy support score
Measured: follow-up (6 months after program conclusion)
Parent-child shared activities - youth report
Count of parent-child shared activities
Measured: baseline (1 week before program start)
Parent-child shared activities - youth report
Count of parent-child shared activities
Measured: post-intervention (1 week after program conclusion)
Parent-child shared activities - youth report
Count of parent-child shared activities
Measured: follow-up (6 months after program conclusion)
Family cohesion - youth report
Mean family cohesion score
Measured: baseline (1 week before program start)
Family cohesion - youth report
Mean family cohesion score
Measured: post-intervention (1 week after program conclusion)
Family cohesion - youth report
Mean family cohesion score
Measured: follow-up (6 months after program conclusion)
Family conflict resolution - youth report
Mean family conflict resolution score
Measured: baseline (1 week before program start)
Family conflict resolution - youth report
Mean family conflict resolution score
Measured: post-intervention (1 week after program conclusion)
Family conflict resolution - youth report
Mean family conflict resolution score
Measured: follow-up (6 months after program conclusion)
Family expressiveness - youth report
Mean family expressiveness score
Measured: baseline (1 week before program start)
Family expressiveness - youth report
Mean family expressiveness score
Measured: post-intervention (1 week after program conclusion)
Family expressiveness - youth report
Mean family expressiveness score
Measured: follow-up (6 months after program conclusion)
Lakota cultural socialization - youth report
Mean Lakota cultural socialization score
Measured: baseline (1 week before program start)
Lakota cultural socialization - youth report
Mean Lakota cultural socialization score
Measured: post-intervention (1 week after program conclusion)
Lakota cultural socialization - youth report
Mean Lakota cultural socialization score
Measured: follow-up (6 months after program conclusion)
Youth perceived parental disapproval of alcohol, tobacco, and marijuana
Mean disapproval of alcohol, tobacco, and marijuana score
Measured: baseline (1 week before program start)
Youth perceived parental disapproval of alcohol, tobacco, and marijuana
Mean disapproval of alcohol, tobacco, and marijuana score
Measured: post-intervention (1 week after program conclusion)
Youth perceived parental disapproval of alcohol, tobacco, and marijuana
Mean disapproval of alcohol, tobacco, and marijuana score
Measured: follow-up (6 months after program conclusion)
Descriptive norms for alcohol, tobacco, and marijuana - youth report
Mean descriptive norms for alcohol, tobacco, and marijuana score
Measured: baseline (1 week before program start)
Descriptive norms for alcohol, tobacco, and marijuana - youth report
Mean descriptive norms for alcohol, tobacco, and marijuana score
Measured: post-intervention (1 week after program conclusion)
Descriptive norms for alcohol, tobacco, and marijuana - youth report
Mean descriptive norms for alcohol, tobacco, and marijuana score
Measured: follow-up (6 months after program conclusion)
Youth antisocial behavior
Mean antisocial behavior score
Measured: baseline (1 week before program start)
Youth antisocial behavior
Mean antisocial behavior score
Measured: post-intervention (1 week after program conclusion)
Youth antisocial behavior
Mean antisocial behavior score
Measured: follow-up (6 months after program conclusion)
Youth prosocial behavior
Mean prosocial behavior score
Measured: baseline (1 week before program start)
Youth prosocial behavior
Mean prosocial behavior score
Measured: post-intervention (1 week after program conclusion)
Youth prosocial behavior
Mean prosocial behavior score
Measured: follow-up (6 months after program conclusion)
Youth deviant peer influences
Mean deviant peer influences score
Measured: baseline (1 week before program start)
Youth deviant peer influences
Mean deviant peer influences score
Measured: post-intervention (1 week after program conclusion)
Youth deviant peer influences
Mean deviant peer influences score
Measured: follow-up (6 months after program conclusion)
Youth prosocial peer influences
Mean prosocial peer influences score
Measured: baseline (1 week before program start)
Youth prosocial peer influences
Mean prosocial peer influences score
Measured: post-intervention (1 week after program conclusion)
Youth prosocial peer influences
Mean prosocial peer influences score
Measured: follow-up (6 months after program conclusion)
Youth peer resistance skills
Mean peer resistance skills score
Measured: baseline (1 week before program start)
Youth peer resistance skills
Mean peer resistance skills score
Measured: post-intervention (1 week after program conclusion)
Youth peer resistance skills
Mean peer resistance skills score
Measured: follow-up (6 months after program conclusion)
Youth lifetime history of stressful life events
Count of stressful events
Measured: baseline (1 week before program start)
Youth lifetime history of stressful life events
Count of stressful events
Measured: post-intervention (1 week after program conclusion)
Youth lifetime history of stressful life events
Count of stressful events
Measured: follow-up (6 months after program conclusion)
Youth stress management skills
Mean stress management skills score
Measured: baseline (1 week before program start)
Youth stress management skills
Mean stress management skills score
Measured: post-intervention (1 week after program conclusion)
Youth stress management skills
Mean stress management skills score
Measured: follow-up (6 months after program conclusion)
Youth psychological well-being
Mean psychological well-being score
Measured: baseline (1 week before program start)
Youth psychological well-being
Mean psychological well-being score
Measured: post-intervention (1 week after program conclusion)
Youth psychological well-being
Mean psychological well-being score
Measured: follow-up (6 months after program conclusion)
Youth knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: baseline (1 week before program start)
Youth knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: post-intervention (1 week after program conclusion)
Youth knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: follow-up (6 months after program conclusion)
Youth self-esteem
Mean self-esteem score
Measured: baseline (1 week before program start)
Youth self-esteem
Mean self-esteem score
Measured: post-intervention (1 week after program conclusion)
Youth self-esteem
Mean self-esteem score
Measured: follow-up (6 months after program conclusion)
General parent-child communication - parent/guardian report
Mean general parent-child communication score
Measured: baseline (1 week before program start)
General parent-child communication - parent/guardian report
Mean general parent-child communication score
Measured: post-intervention (1 week after program conclusion)
General parent-child communication - parent/guardian report
Mean general parent-child communication score
Measured: follow-up (6 months after program conclusion)
Parent-child communication about family issues - parent/guardian report
Mean general parent-child communication about family issues score
Measured: baseline (1 week before program start)
Parent-child communication about family issues - parent/guardian report
Mean general parent-child communication about family issues score
Measured: post-intervention (1 week after program conclusion)
Parent-child communication about family issues - parent/guardian report
Mean general parent-child communication about family issues score
Measured: follow-up (6 months after program conclusion)
Parent-child communication about alcohol and drugs - parent/guardian report
Mean parent-child communication about alcohol and drugs score
Measured: baseline (1 week before program start)
Parent-child communication about alcohol and drugs - parent/guardian report
Mean parent-child communication about alcohol and drugs score
Measured: post-intervention (1 week after program conclusion)
Parent-child communication about alcohol and drugs - parent/guardian report
Mean parent-child communication about alcohol and drugs score
Measured: follow-up (6 months after program conclusion)
Parent/guardian report of youth behavior
Mean youth behavior score
Measured: baseline (1 week before program start)
Parent/guardian report of youth behavior
Mean youth behavior score
Measured: post-intervention (1 week after program conclusion)
Parent/guardian report of youth behavior
Mean youth behavior score
Measured: follow-up (6 months after program conclusion)
Parent/guardian report parent-child shared activities
Count of shared activities
Measured: baseline (1 week before program start)
Parent/guardian report parent-child shared activities
Count of shared activities
Measured: post-intervention (1 week after program conclusion)
Parent/guardian report parent-child shared activities
Count of shared activities
Measured: follow-up (6 months after program conclusion)
Parental monitoring - parent/guardian report
Mean parental monitoring score
Measured: baseline (1 week before program start)
Parental monitoring - parent/guardian report
Mean parental monitoring score
Measured: post-intervention (1 week after program conclusion)
Parental monitoring - parent/guardian report
Mean parental monitoring score
Measured: follow-up (6 months after program conclusion)
General family rules - parent/guardian report
Mean family rules score
Measured: baseline (1 week before program start)
General family rules - parent/guardian report
Mean family rules score
Measured: post-intervention (1 week after program conclusion)
General family rules - parent/guardian report
Mean family rules score
Measured: follow-up (6 months after program conclusion)
Family rules about substance use - parent/guardian report
Mean substance use rules score
Measured: baseline (1 week before program start)
Family rules about substance use - parent/guardian report
Mean substance use rules score
Measured: post-intervention (1 week after program conclusion)
Family rules about substance use - parent/guardian report
Mean substance use rules score
Measured: follow-up (6 months after program conclusion)
Parent discipline practices
Mean parent discipline practices score
Measured: baseline (1 week before program start)
Parent discipline practices
Mean parent discipline practices score
Measured: post-intervention (1 week after program conclusion)
Parent discipline practices
Mean parent discipline practices score
Measured: follow-up (6 months after program conclusion)
Other household member discipline practices
Mean other household member discipline practices score
Measured: baseline (1 week before program start)
Other household member discipline practices
Mean other household member discipline practices score
Measured: post-intervention (1 week after program conclusion)
Other household member discipline practices
Mean other household member discipline practices score
Measured: follow-up (6 months after program conclusion)
Standard setting
Mean standard setting score
Measured: baseline (1 week before program start)
Standard setting
Mean standard setting score
Measured: post-intervention (1 week after program conclusion)
Standard setting
Mean standard setting score
Measured: follow-up (6 months after program conclusion)
Parent-child conflict, parent/guardian report
Mean parent-child conflict score
Measured: baseline (1 week before program start)
Parent-child conflict, parent/guardian report
Mean parent-child conflict score
Measured: post-intervention (1 week after program conclusion)
Parent-child conflict, parent/guardian report
Mean parent-child conflict score
Measured: follow-up (6 months after program conclusion)
Parent support, parent/guardian report
Mean parent support score
Measured: baseline (1 week before program start)
Parent support, parent/guardian report
Mean parent support score
Measured: post-intervention (1 week after program conclusion)
Parent support, parent/guardian report
Mean parent support score
Measured: follow-up (6 months after program conclusion)
Parental positive affect, parent/guardian report
Mean parental positive affect score
Measured: baseline (1 week before program start)
Parental positive affect, parent/guardian report
Mean parental positive affect score
Measured: post-intervention (1 week after program conclusion)
Parental positive affect, parent/guardian report
Mean parental positive affect score
Measured: follow-up (6 months after program conclusion)
Parental negative affect, parent/guardian report
Mean parental negative affect score
Measured: baseline (1 week before program start)
Parental negative affect, parent/guardian report
Mean parental negative affect score
Measured: post-intervention (1 week after program conclusion)
Parental negative affect, parent/guardian report
Mean parental negative affect score
Measured: follow-up (6 months after program conclusion)
Parental anger management, parent/guardian report
Mean parental anger management score
Measured: baseline (1 week before program start)
Parental anger management, parent/guardian report
Mean parental anger management score
Measured: post-intervention (1 week after program conclusion)
Parental anger management, parent/guardian report
Mean parental anger management score
Measured: follow-up (6 months after program conclusion)
Parental self-efficacy
Mean parental self-efficacy
Measured: baseline (1 week before program start)
Parental self-efficacy
Mean parental self-efficacy
Measured: post-intervention (1 week after program conclusion)
Parental self-efficacy
Mean parental self-efficacy
Measured: follow-up (6 months after program conclusion)
Family meetings, parent/guardian report
Mean family meetings score
Measured: baseline (1 week before program start)
Family meetings, parent/guardian report
Mean family meetings score
Measured: post-intervention (1 week after program conclusion)
Family meetings, parent/guardian report
Mean family meetings score
Measured: follow-up (6 months after program conclusion)
Family cohesion, parent/guardian report
Mean family cohesion score
Measured: baseline (1 week before program start)
Family cohesion, parent/guardian report
Mean family cohesion score
Measured: post-intervention (1 week after program conclusion
Family cohesion, parent/guardian report
Mean family cohesion score
Measured: follow-up (6 months after program conclusion)
Family conflict resolution, parent/guardian report
Mean family conflict resolution score
Measured: baseline (1 week before program start)
Family conflict resolution, parent/guardian report
Mean family conflict resolution score
Measured: post-intervention (1 week after program conclusion)
Family conflict resolution, parent/guardian report
Mean family conflict resolution score
Measured: follow-up (6 months after program conclusion)
Family expressiveness, parent/guardian report
Mean family expressiveness score
Measured: baseline (1 week before program start)
Family expressiveness, parent/guardian report
Mean family expressiveness score
Measured: post-intervention (1 week after program conclusion)
Family expressiveness, parent/guardian report
Mean family expressiveness score
Measured: follow-up (6 months after program conclusion)
Lakota cultural socialization, parent/guardian report
Mean Lakota cultural socialization score
Measured: baseline (1 week before program start)
Lakota cultural socialization, parent/guardian report
Mean Lakota cultural socialization score
Measured: post-intervention (1 week after program conclusion)
Lakota cultural socialization, parent/guardian report
Mean Lakota cultural socialization score
Measured: follow-up (6 months after program conclusion)
Lakota parenting practices
Mean Lakota parenting practices score
Measured: baseline (1 week before program start)
Lakota parenting practices
Mean Lakota parenting practices score
Measured: post-intervention (1 week after program conclusion)
Lakota parenting practices
Mean Lakota parenting practices score
Measured: follow-up (6 months after program conclusion)
Knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: baseline (1 week before program start)
Knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: post-intervention (1 week after program conclusion)
Knowledge of Lakota kinship terminology
Count of correct Lakota kinship terms
Measured: follow-up (6 months after program conclusion)
Parent lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: baseline (1 week before program start)
Parent lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime alcohol use
Lifetime prevalence of alcohol use
Measured: follow-up (6 months after program conclusion)
Parent past month alcohol use
Mean frequency of past month alcohol use
Measured: baseline (1 week before program start)
Parent past month alcohol use
Mean frequency of past month alcohol use
Measured: post-intervention (1 week after program conclusion)
Parent past month alcohol use
Mean frequency of past month alcohol use
Measured: follow-up (6 months after program conclusion)
Parent past month alcohol use quantity
Mean usual quantity of past month alcohol consumption
Measured: baseline (1 week before program start)
Parent past month alcohol use quantity
Mean usual quantity of past month alcohol consumption
Measured: post-intervention (1 week after program conclusion)
Parent past month alcohol use quantity
Mean usual quantity of past month alcohol consumption
Measured: follow-up (6 months after program conclusion)
Parent past month alcohol use maximum quantity
Mean maximum quantity of past month alcohol consumption
Measured: baseline (1 week before program start)
Parent past month alcohol use maximum quantity
Mean maximum quantity of past month alcohol consumption
Measured: post-intervention (1 week after program conclusion)
Parent past month alcohol use maximum quantity
Mean maximum quantity of past month alcohol consumption
Measured: follow-up (6 months after program conclusion)
Parent past month alcohol use usual quantity
Mean usual quantity of past month alcohol consumption
Measured: baseline (1 week before program start)
Parent past month alcohol use usual quantity
Mean usual quantity of past month alcohol consumption
Measured: post-intervention (1 week after program conclusion)
Parent past month alcohol use usual quantity
Mean usual quantity of past month alcohol consumption
Measured: follow-up (6 months after program conclusion)
Parent past month alcohol intoxication frequency
Mean frequency of past month alcohol intoxication
Measured: baseline (1 week before program start)
Parent past month alcohol intoxication frequency
Mean frequency of past month alcohol intoxication
Measured: post-intervention (1 week after program conclusion)
Parent past month alcohol intoxication frequency
Mean frequency of past month alcohol intoxication
Measured: follow-up (6 months after program conclusion)
Parent first age of alcohol use
Mean age of first alcohol use
Measured: baseline (1 week before program start)
Parent first age of alcohol use
Mean age of first alcohol use
Measured: post-intervention (1 week after program conclusion)
Parent first age of alcohol use
Mean age of first alcohol use
Measured: follow-up (6 months after program conclusion)
Parent first age of alcohol intoxication
Mean age of first alcohol intoxication
Measured: baseline (1 week before program start)
Parent first age of alcohol intoxication
Mean age of first alcohol intoxication
Measured: post-intervention (1 week after program conclusion)
Parent first age of alcohol intoxication
Mean age of first alcohol intoxication
Measured: follow-up (6 months after program conclusion)
Parent lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: baseline (1 week before program start)
Parent lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime cigarette use
Lifetime prevalence of cigarette use
Measured: follow-up (6 months after program conclusion)
Parent past month cigarette use
Mean frequency and quantity of past month cigarette use
Measured: baseline (1 week before program start)
Parent past month cigarette use
Mean frequency and quantity of past month cigarette use
Measured: post-intervention (1 week after program conclusion)
Parent past month cigarette use
Mean frequency and quantity of past month cigarette use
Measured: follow-up (6 months after program conclusion)
Parent age of first cigarette use
Mean age of first cigarette use
Measured: baseline (1 week before program start)
Parent age of first cigarette use
Mean age of first cigarette use
Measured: post-intervention (1 week after program conclusion)
Parent age of first cigarette use
Mean age of first cigarette use
Measured: follow-up (6 months after program conclusion)
Parent lifetime smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: baseline (1 week before program start)
Parent lifetime smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime smokeless tobacco use
Lifetime prevalence of smokeless tobacco use
Measured: follow-up (6 months after program conclusion)
Parent past month smokeless tobacco use
Mean frequency and quantity of past month smokeless tobacco use
Measured: baseline (1 week before program start)
Parent past month smokeless tobacco use
Mean frequency and quantity of past month smokeless tobacco use
Measured: post-intervention (1 week after program conclusion)
Parent past month smokeless tobacco use
Mean frequency and quantity of past month smokeless tobacco use
Measured: follow-up (6 months after program conclusion)
Parent age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: baseline (1 week before program start)
Parent age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: post-intervention (1 week after program conclusion)
Parent age of first smokeless tobacco use
Mean age of first smokeless tobacco use
Measured: follow-up (6 months after program conclusion)
Parent lifetime e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: baseline (1 week before program start)
Parent lifetime e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime e-cigarette use
Lifetime prevalence of e-cigarette use
Measured: follow-up (6 months after program conclusion)
Parent frequency of past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: baseline (1 week before program start)
Parent frequency of past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: post-intervention (1 week after program conclusion)
Parent frequency of past-month e-cigarette use
Mean frequency of past month e-cigarette use
Measured: follow-up (6 months after program conclusion)
Parent lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: baseline (1 week before program start)
Parent lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime marijuana use
Lifetime prevalence of marijuana use
Measured: follow-up (6 months after program conclusion)
Parent past-month marijuana use
Mean frequency of past month marijuana use
Measured: baseline (1 week before program start)
Parent past-month marijuana use
Mean frequency of past month marijuana use
Measured: post-intervention (1 week after program conclusion)
Parent past-month marijuana use
Mean frequency of past month marijuana use
Measured: follow-up (6 months after program conclusion)
Parent age of first marijuana use
Mean age of first marijuana use
Measured: baseline (1 week before program start)
Parent age of first marijuana use
Mean age of first marijuana use
Measured: post-intervention (1 week after program conclusion)
Parent age of first marijuana use
Mean age of first marijuana use
Measured: follow-up (6 months after program conclusion)
Parent lifetime huffing
Lifetime prevalence of huffing/inhalant use
Measured: baseline (1 week before program start)
Parent lifetime huffing
Lifetime prevalence of huffing/inhalant use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime huffing
Lifetime prevalence of huffing/inhalant use
Measured: follow-up (6 months after program conclusion)
Parent past month huffing
Mean frequency of past month huffing/inhalant use
Measured: baseline (1 week before program start)
Parent past month huffing
Mean frequency of past month huffing/inhalant use
Measured: post-intervention (1 week after program conclusion)
Parent past month huffing
Mean frequency of past month huffing/inhalant use
Measured: follow-up (6 months after program conclusion)
Parent age of first huffing
Mean age of first huffing/inhalant use
Measured: baseline (1 week before program start)
Parent age of first huffing
Mean age of first huffing/inhalant use
Measured: post-intervention (1 week after program conclusion)
Parent age of first huffing
Mean age of first huffing/inhalant use
Measured: follow-up (6 months after program conclusion)
Parent lifetime use of non-prescription painkillers
Lifetime prevalence of non-prescription painkiller use
Measured: baseline (1 week before program start)
Parent lifetime use of non-prescription painkillers
Lifetime prevalence of non-prescription painkiller use
Measured: post-intervention (1 week after program conclusion
Parent lifetime use of non-prescription painkillers
Lifetime prevalence of non-prescription painkiller use
Measured: follow-up (6 months after program conclusion)
Parent past month non-prescription painkiller use
Mean frequency of past month non-prescription painkiller use
Measured: baseline (1 week before program start)
Parent past month non-prescription painkiller use
Mean frequency of past month non-prescription painkiller use
Measured: post-intervention (1 week after program conclusion)
Parent past month non-prescription painkiller use
Mean frequency of past month non-prescription painkiller use
Measured: follow-up (6 months after program conclusion)
Parent lifetime stimulant use
Lifetime prevalence of stimulant use
Measured: baseline (1 week before program start)
Parent lifetime stimulant use
Lifetime prevalence of stimulant use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime stimulant use
Lifetime prevalence of stimulant use
Measured: follow-up (6 months after program conclusion)
Parent past month stimulant use
Mean frequency of past month huffing/inhalant use
Measured: baseline (1 week before program start)
Parent past month stimulant use
Mean frequency of past month huffing/inhalant use
Measured: post-intervention (1 week after program conclusion)
Parent past month stimulant use
Mean frequency of past month huffing/inhalant use
Measured: follow-up (6 months after program conclusion)
Parent lifetime sedative use
Lifetime prevalence of sedative use
Measured: baseline (1 week before program start)
Parent lifetime sedative use
Lifetime prevalence of sedative use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime sedative use
Lifetime prevalence of sedative use
Measured: follow-up (6 months after program conclusion)
Parent past month sedative use
Mean frequency of past month sedative use
Measured: baseline (1 week before program start)
Parent past month sedative use
Mean frequency of past month sedative use
Measured: post-intervention (1 week after program conclusion)
Parent past month sedative use
Mean frequency of past month sedative use
Measured: follow-up (6 months after program conclusion)
Parent lifetime heroin use
Lifetime prevalence of heroin use
Measured: baseline (1 week before program start)
Parent lifetime heroin use
Lifetime prevalence of heroin use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime heroin use
Lifetime prevalence of heroin use
Measured: follow-up (6 months after program conclusion)
Parent past month heroin use
Mean frequency of past month heroin use
Measured: baseline (1 week before program start)
Parent past month heroin use
Mean frequency of past month heroin use
Measured: post-intervention (1 week after program conclusion)
Parent past month heroin use
Mean frequency of past month heroin use
Measured: follow-up (6 months after program conclusion)
Parent lifetime methamphetamine use
Lifetime prevalence of methamphetamine use
Measured: baseline (1 week before program start)
Parent lifetime methamphetamine use
Lifetime prevalence of methamphetamine use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime methamphetamine use
Lifetime prevalence of methamphetamine use
Measured: follow-up (6 months after program conclusion)
Parent past month methamphetamine use
Mean frequency of past month methamphetamine use
Measured: baseline (1 week before program start)
Parent past month methamphetamine use
Mean frequency of past month methamphetamine use
Measured: post-intervention (1 week after program conclusion)
Parent past month methamphetamine use
Mean frequency of past month methamphetamine use
Measured: follow-up (6 months after program conclusion)
Parent lifetime hallucinogen use
Lifetime prevalence of hallucinogen use
Measured: baseline (1 week before program start)
Parent lifetime hallucinogen use
Lifetime prevalence of hallucinogen use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime hallucinogen use
Lifetime prevalence of hallucinogen use
Measured: follow-up (6 months after program conclusion)
Parent past month hallucinogen use
Mean frequency of past month hallucinogen use
Measured: baseline (1 week before program start)
Parent past month hallucinogen use
Mean frequency of past month hallucinogen use
Measured: post-intervention (1 week after program conclusion)
Parent past month hallucinogen use
Mean frequency of past month hallucinogen use
Measured: follow-up (6 months after program conclusion)
Parent lifetime club drug use
Lifetime prevalence of club drug use
Measured: baseline (1 week before program start)
Parent lifetime club drug use
Lifetime prevalence of club drug use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime club drug use
Lifetime prevalence of club drug use
Measured: follow-up (6 months after program conclusion)
Parent past month club drug use
Mean frequency of past month club drug use
Measured: baseline (1 week before program start)
Parent past month club drug use
Mean frequency of past month club drug use
Measured: post-intervention (1 week after program conclusion)
Parent past month club drug use
Mean frequency of past month club drug use
Measured: follow-up (6 months after program conclusion)
Parent lifetime cocaine/crack use
Lifetime prevalence of cocaine/crack use
Measured: baseline (1 week before program start)
Parent lifetime cocaine/crack use
Lifetime prevalence of cocaine/crack use
Measured: post-intervention (1 week after program conclusion)
Parent lifetime cocaine/crack use
Lifetime prevalence of cocaine/crack use
Measured: follow-up (6 months after program conclusion)
Parent past month cocaine/crack use
Mean frequency of past month cocaine/crack use
Measured: baseline (1 week before program start)
Parent past month cocaine/crack use
Mean frequency of past month cocaine/crack use
Measured: follow-up (6 months after program conclusion)
Parent HIV risk behavior
Lifetime prevalence of HIV risk behavior
Measured: baseline (1 week before program start)
Parent HIV risk behavior
Lifetime prevalence of HIV risk behavior
Measured: post-intervention (1 week after program conclusion)
Parent HIV risk behavior
Lifetime prevalence of HIV risk behavior
Measured: follow-up (6 months after program conclusion)
Parent psychological distress
Mean psychological distress score
Measured: baseline (1 week before program start)
Parent psychological distress
Mean psychological distress score
Measured: post-intervention (1 week after program conclusion)
Parent psychological distress
Mean psychological distress score
Measured: follow-up (6 months after program conclusion)
Parent life satisfaction
Mean life satisfaction score
Measured: baseline (1 week before program start)
Parent life satisfaction
Mean life satisfaction score
Measured: post-intervention (1 week after program conclusion)
Parent life satisfaction
Mean life satisfaction score
Measured: follow-up (6 months after program conclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start15 Jun 2013
- Primary completion4 Jan 2018
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy R Whitesell, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383225
- Sponsor's protocol ID
- 12-1641
- Status last verified
- Mar 2020
- First submitted
- 30 Dec 2014
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Grounded Early Substance Use Prevention for American Indian Families
- ClinicalTrials.gov ID
- NCT02383225
- Acronym / sponsor ID
- 12-1641
- Conditions
- Substance Use
- Keywords
- American Indian, Adolescent, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Jun 2013 (actual)
- Primary completion
- 4 Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves adaptation, implementation, and rigorous evaluation of a family-based program designed to prevent early initiation of substance use on a Northern Plains Indian reservation. The program, Thiwáhe Gluwáš'akapi, is a cultural adaptation of the Iowa Strengthening Families Program for Parents and Youth 10-14. Youth and their parents/caregivers will participate in weekly group sessions for 7 weeks and complete pre- and post-intervention surveys assessing a variety of risk and protective factors and youth outcomes. The evaluation design will allow the assessment of the effectiveness of different components within the program.
Detailed description
Feasibility Pilot
A feasibility pilot for the Thiwáhe Gluwáš'akapi (TG) program will be conducted in the Spring of 2015. In the pilot, the intervention will be delivered to two groups of youth and families and the implementation process will be carefully evaluated to determine what works well and where further adaptation of the intervention or the study procedures may be necessary. Particular attention will be paid to retention of families and, if possible, any who drop out will be interviewed to understand barriers to participation.
As with the intervention evaluation itself (see below) youth aged 10-14 will be recruited to participate, along with their parents and/or other adults (up to 3 adults per child) who are actively involved in raising them (e.g., grandparents, aunts, uncles). Pilot groups will be conducted in each of two different communities on the reservation.
Once the feasibility pilot is complete, the intervention will be finalized for efficacy evaluation. Tasks for this phase will include refining the manual for the intervention and further developing training materials for interventionists.
Implementation/Component Evaluation
The formal evaluation of TG will begin in the fall of 2015 and will utilize the principles of Multiphase Optimization Strategy (MOST; Collins et al., 2009) for intervention development and a fractional factorial design to evaluate the relative effectiveness of different components within the intervention. Three components will be evaluated: (1) A Lakota language enhancement (Lakota), (2) a Facebook social media enhancement (FB), and (3) substance use resistance skill content (SU). A total of 24 intervention groups will be randomly assigned to one of 4 MOST design conditions, with the content of each condition determined using SAS PROC FACTEX, as recommended by Collins, et al, 2009. All 4 conditions will consist of the basic TG program, each supplemented by one or more of 3 components designated above: Condition A will include the substance use resistance content (SU; no Lakota or FB); Condition B will include the FB social media supplement (FB; no Lakota or SU); Condition C will include the Lakota language enhancement (Lakota; no FB or SU); and Condition D will include all three components (Lakota + FB + SU).
A cumulative evidence design will be utilized, with the intervention implemented in 5 cohorts across 3 years. The intervention will be delivered to 4 groups (8 families each) in Cohort 1 in the fall of 2015. Additional cohorts will receive the intervention each fall and spring through 2017 as follows: Cohort 2, Spring 2016, 4 groups; Cohort 3, Fall 2016, 6 groups; Cohort 4, Spring 2017, 6 groups; and Cohort 5, Fall 2017, 4 groups. Thus, by the end of 2017, 24 intervention groups (each 8 families, total of 192 families) will have participated in the TG program. Cohorts will be randomly assigned to the 4 MOST design conditions in order to control for potential order of implementation effects.
Power analysis
Power analyses suggest that this design will result in adequate power (>.80) to detect a small effect (d=.15) with 48 families per condition; for the 4 conditions in the design, this will require a total of 192 families (not including 16 pilot families). TG, following Iowa Strengthening Families Program (ISFP) recommendations, will be delivered in family groups of 8 families each; thus, in order to involve 192 families, we plan a total of 24 intervention groups, with 6 in each the 4 experimental conditions. Each component targeted for evaluation will be implemented in 2 of the 4 conditions (see conditions A-B above), and estimates of each effect will thus be based on marginal Ns of 96 families. As is standard with MOST designs, there will not be a no-intervention control group nor will there be a group that receives every component. While this is a different approach than an randomized controlled trial (RCT) design, it is a rigorous and optimal approach for identifying the most effective components to include in an intervention. The intervention created using this process will be ready for a standard RCT evaluation, and more likely to be proven effective there.
Implementation evaluation
Fidelity across implementations will be ensured by using a detailed manual of procedures, providing extensive training for interventionists, and using fidelity logs to asses delivery of key session components. The intervention director, a clinical psychologist, will observe sessions periodically and verify the extent to which implementation is occurring with fidelity to the TG program manual.
Efficacy evaluation
The primary impetus for the development and implementation of the TG program is the desire to reduce risk for substance abuse problems among American Indian adolescents by preventing early initiation of substance use. Assessment of the success of the TG program components will hinge on observed impacts on substance use initiation and on the putative mediators of parental self-efficacy, strengthened family relationships, and cultural knowledge and values. Given the short timeline of the outcome evaluations (limited to 6 months post-intervention), effects on mediators are anticipated to stronger than distal effects on behavioral outcomes.
Measures
Measures used to assess study outcomes draw heavily from the investigators' previous research with young American Indian adolescents and their parents, and from previous evaluations of the Iowa Strengthening Families Program for Parents and Youth 10-14. Two instruments will be used to assess an array of outcomes expected to be affected by the TG intervention, along with demographic data: a Parent Survey (for parents and other caregivers participating in the TG program with youth), and a Youth Survey. Both the Parent Survey and Youth Survey will be administered electronically, using tablet computers connected to the Internet, with data uploaded directly. In addition, a Social Network Survey will be administered (either on an electronic tablet or on paper) to participating parents/caregivers; this survey is designed to assess the strength of the connections among participants in the program, both before and after participation in the program. A small number of participants (3-4) in each group assigned to the FaceBook condition will be asked to participate in Exit Interviews (by phone) to ascertain their use of and response to the social media messages provided between TG sessions. Data will also be captured from Facebook, including page visits, posts, and responses to online quizzes. Finally, participants will be asked to complete a Program Evaluation Form (Parent or Youth versions, on paper) at their last TG session, to provide feedback on the program and facilitators.
Data Collection Schedule
Time 1 - One week prior to the first TG session: Parent and Youth surveys (all participants).
Time 2 - First TG session: Social Network Surveys (adults).
Time 3 - One week after last TG session: Parent and Youth Surveys (all participants); Social Network Survey (adults)
Time 4 - Within two weeks after final TG session: FaceBook Exit Interviews (3-4 adult participants in each condition including the FaceBook supplement)
Time 5 - Approximately 6 months after the last TG session: Parent and Youth Surveys (all participants in the first two intervention cohorts)
Analyses
The simplest analyses for the evaluation of the TG program, using the MOST design, will involve analysis of variance (ANOVA), using the fractional factorial design described above, comparing post-intervention values (Time 3 and Time 5) on both mediators and outcomes across conditions (assuming that randomization across conditions will result in roughly equivalent pre-intervention values). Repeated measures ANOVA will also be performed, including both pre- and post-intervention measures, looking for interactions between time and condition. Finally, multivariate ANOVAs will be estimated for groups of outcome variables, to examine patterns of effects across outcomes. For all analyses, the focus will be on effect sizes (rather than significance tests and p values) to compare effect sizes across components to guide decisions about what should be retained in the optimized TG intervention. As noted above, standard errors will be adjusted to account for intraclass correlations and clustering of families within intervention groups. Analyses of the Social Network Measure will focus on assessing density and cohesion at the network level, to address two primary questions: First, do network characteristics at the beginning of the program (pre-existing relationships within intervention groups) modify the effect of the TG intervention within those groups and, second, do network characteristics change over the course of the TG intervention as new relationships are formed and existing relationships changed. Analyses will be conducted using UCINET or similar social network analysis software. Analyses of the Facebook data will be primarily descriptive, examining the frequency with which participants engage with the Facebook page for their TG group by posting comments, or responding to polls or quizzes. Exploratory analyses may be used to examine correlations between group rates of Facebook use and group-level outcomes, such as increased cohesion as measured by the Social Network Analysis. Analyses of Facebook Exit Interviews will be primarily notes-based content analysis and will involve three major stages of analysis: open coding, axial coding, and selective coding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition A | Experimental | Behavioral: Substance Use Resistance SkillsSubstance use resistance skills; no Lakota language enhancement, no FaceBook supplement |
| Condition B | Experimental | Behavioral: Facebook SupplementFaceBook supplement; no Lakota language enhancement; no Substance Use resistance skills |
| Condition C | Experimental | Behavioral: Lakota Language enhancementLakota language enhancement; no FaceBook supplement; no Substance Use resistance skills |
| Condition D | Experimental | Behavioral: Lakota Language enhancement, Behavioral: Facebook Supplement, Behavioral: Substance Use Resistance SkillsLakota language enhancement; FaceBook supplement; Substance Use resistance skills |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Youth aged 10-14 years and their families, with connection to the South Dakota Indian Reservation where the study is being conducted. Families may include parents, extended family, guardians, and others living in the household.
Key exclusion criteria (2 listed)
- Individuals without a child in the family aged 10-14 will not be allowed to participate.
- Youth who are not between 10 and 14 years of age will not be allowed to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lakota Language enhancementThis intervention component includes more extensive adaptation for Lakota families, focusing on use of Lakota language specifically around relationship/kinship terms. Study arms without this component will include the same adapted intervention but with use of English language rather than Lakota. | Behavioural | Condition C, Condition D |
| Facebook SupplementThis intervention component includes a social media supplement to engage families outside of weekly intervention sessions and will include postings and polls for participating parents/other caregivers to complete between sessions. | Behavioural | Condition B, Condition D |
| Substance Use Resistance SkillsThis intervention component consists of the original substance use resistance skills training from the Iowa Strengthening Families Program for Parents and Youth 10-14; arms without this component will include a session on healthy eating and exercise (attention control). | Behavioural | Condition A, Condition D |
Primary outcome
Youth lifetime alcohol use
Time frame: Baseline (1 week before program start)
Lifetime prevalence of alcohol use
Youth lifetime alcohol use
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of alcohol use
Youth lifetime alcohol use
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of alcohol use
Youth past-month alcohol use
Time frame: Baseline (1 week before program start)
Mean frequency of past month alcohol use
Youth past-month alcohol use
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month alcohol use
Youth past-month alcohol use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month alcohol use
Youth maximum alcohol use in past month
Time frame: Baseline (1 week before program start)
Mean maximum quantity of past month alcohol consumption
Youth maximum alcohol use in past month
Time frame: Post-intervention (1 week after program conclusion)
Mean maximum quantity of past month alcohol consumption
Youth maximum alcohol use in past month
Time frame: Follow-up (6 months after program conclusion)
Mean maximum quantity of past month alcohol consumption
Youth age of first alcohol use
Time frame: Baseline (1 week before program start)
Mean age of first alcohol use
Youth age of first alcohol use
Time frame: Post-intervention (1 week after program conclusion)
Mean age of first alcohol use
Youth age of first alcohol use
Time frame: Follow-up (6 months after program conclusion)
Mean age of first alcohol use
Youth lifetime cigarette use
Time frame: Baseline (1 week before program start)
Lifetime prevalence of cigarette use
Youth lifetime cigarette use
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of cigarette use
Youth lifetime cigarette use
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of cigarette use
Youth past-month cigarette use
Time frame: Baseline (1 week before program start)
Mean frequency of past month cigarette use
Youth past-month cigarette use
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month cigarette use
Youth past-month cigarette use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month cigarette use
Youth age of first cigarette use
Time frame: Baseline (1 week before program start)
Mean age of first cigarette use
Youth age of first cigarette use
Time frame: Post-intervention (1 week after program conclusion)
Mean age of first cigarette use
Youth age of first cigarette use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month cigarette use
Youth prevalence of smokeless tobacco use
Time frame: Baseline (1 week before program start)
Lifetime prevalence of smokeless tobacco use
Youth prevalence of smokeless tobacco use
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of smokeless tobacco use
Youth prevalence of smokeless tobacco use
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of smokeless tobacco use
Youth frequency of past-month smokeless tobacco use
Time frame: Baseline (1 week before program start)
Mean frequency of past month smokeless tobacco use
Youth frequency of past-month smokeless tobacco use
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month smokeless tobacco use
Youth frequency of past-month smokeless tobacco use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month smokeless tobacco use
Youth age of first smokeless tobacco use
Time frame: Baseline (1 week before program start)
Mean age of first smokeless tobacco use
Youth age of first smokeless tobacco use
Time frame: Post-intervention (1 week after program conclusion)
Mean age of first smokeless tobacco use
Youth age of first smokeless tobacco use
Time frame: Follow-up (6 months after program conclusion)
Mean age of first smokeless tobacco use
Youth lifetime prevalence of e-cigarette use
Time frame: Baseline (1 week before program start)
Lifetime prevalence of e-cigarette use
Youth lifetime prevalence of e-cigarette use
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of e-cigarette use
Youth lifetime prevalence of e-cigarette use
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of e-cigarette use
Youth past-month e-cigarette use
Time frame: Baseline (1 week before program start)
Mean frequency of past month e-cigarette use
Youth past-month e-cigarette use
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month e-cigarette use
Youth past-month e-cigarette use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month e-cigarette use
Youth lifetime marijuana use
Time frame: Baseline (1 week before program start)
Lifetime prevalence of marijuana use
Youth lifetime marijuana use
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of marijuana use
Youth lifetime marijuana use
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of marijuana use
Youth past-month marijuana use
Time frame: Baseline (1 week before program start)
Mean frequency of past month marijuana use
Youth past-month marijuana use
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month marijuana use
Youth past-month marijuana use
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month marijuana us
Youth age of first marijuana use
Time frame: Baseline (1 week before program start)
Mean age of first marijuana use
Youth age of first marijuana use
Time frame: Post-intervention (1 week after program conclusion)
Mean age of first marijuana use
Youth age of first marijuana use
Time frame: Follow-up (6 months after program conclusion)
Mean age of first marijuana use
Youth lifetime prevalence of huffing glue/gas
Time frame: Baseline (1 week before program start)
Lifetime prevalence of huffing
Youth lifetime prevalence of huffing glue/gas
Time frame: Post-intervention (1 week after program conclusion)
Lifetime prevalence of huffing
Youth lifetime prevalence of huffing glue/gas
Time frame: Follow-up (6 months after program conclusion)
Lifetime prevalence of huffing
Youth past-month huffing
Time frame: Baseline (1 week before program start)
Mean frequency of past month huffing
Youth past-month huffing
Time frame: Post-intervention (1 week after program conclusion)
Mean frequency of past month huffing
Youth past-month huffing
Time frame: Follow-up (6 months after program conclusion)
Mean frequency of past month huffing
Youth age of first huffing
Time frame: Baseline (1 week before program start)
Mean age of first huffing
Youth age of first huffing
Time frame: Post-intervention (1 week after program conclusion)
Mean age of first huffing
Youth age of first huffing
Time frame: Follow-up (6 months after program conclusion)
Mean age of first huffing
275 secondary outcomes
Youth perceived consistency of parental discipline practices
Time frame: baseline (1 week before program start)
Youth perceived consistency of parental discipline practices
Time frame: post-intervention (1 week after program conclusion)
Youth perceived consistency of parental discipline practices
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental standard setting
Time frame: baseline (1 week before program start)
Youth perceived parental standard setting
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parental standard setting
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental monitoring
Time frame: baseline (1 week before program start)
Youth perceived parental monitoring
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parental monitoring
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental positive affect
Time frame: baseline (1 week before program start)
Youth perceived parental positive affect
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parental positive affect
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental approval
Time frame: baseline (1 week before program start)
Youth perceived parental approval
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parental approval
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental negative affect
Time frame: baseline (1 week before program start)
Youth perceived parental negative affect
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parental negative affect
Time frame: follow-up (6 months after program conclusion)
Youth perceived parent-child communication
Time frame: baseline (1 week before program start)
Youth perceived parent-child communication
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parent-child communication
Time frame: follow-up (6 months after program conclusion)
Youth perceived parent-child communication about alcohol and drugs
Time frame: baseline (1 week before program start)
Youth perceived parent-child communication about alcohol and drugs
Time frame: post-intervention (1 week after program conclusion)
Youth perceived parent-child communication about alcohol and drugs
Time frame: follow-up (6 months after program conclusion)
Youth perceived enforcement of family rules
Time frame: baseline (1 week before program start)
Youth perceived enforcement of family rules
Time frame: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Youth perceived enforcement of family rules
Time frame: follow-up (6 months after program conclusion)
Youth perceived parental autonomy support
Time frame: baseline (1 week before program start)
Youth perceived parental autonomy support
Time frame: post-intervention (1 week after program conclusion); follow-up (6 months after program conclusion)
Youth perceived parental autonomy support
Time frame: follow-up (6 months after program conclusion)
Parent-child shared activities - youth report
Time frame: baseline (1 week before program start)
Parent-child shared activities - youth report
Time frame: post-intervention (1 week after program conclusion)
Parent-child shared activities - youth report
Time frame: follow-up (6 months after program conclusion)
Family cohesion - youth report
Time frame: baseline (1 week before program start)
Family cohesion - youth report
Time frame: post-intervention (1 week after program conclusion)
Family cohesion - youth report
Time frame: follow-up (6 months after program conclusion)
Family conflict resolution - youth report
Time frame: baseline (1 week before program start)
Family conflict resolution - youth report
Time frame: post-intervention (1 week after program conclusion)
Family conflict resolution - youth report
Time frame: follow-up (6 months after program conclusion)
Family expressiveness - youth report
Time frame: baseline (1 week before program start)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy R Whitesell, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lakota Language enhancement, Facebook Supplement and Substance Use Resistance Skills in people with Substance Use, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth lifetime alcohol use (time frame: Baseline (1 week before program start)). The study lists 54 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.