Substance UseNCT04222556
Evaluation of Thiwáhe Gluwáš'Akapi Substance Use Prevention Program
A study testing Thiwáhe Gluwáš'akapi and Woyute Waśte in people with Substance Use and Substance Abuse, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains… 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, Substance Abuse, Suicide
- What is being tested?
- Thiwáhe Gluwáš'akapi and Woyute Waśte
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to 28 Feb 2025
- 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 participants:
- 10-12 years old on the date of the first program session
- Attending school on the reservation
- Must enroll with an eligible adult
- Adult participants:
- At least 18 years old
- Must enroll with an eligible child
- Must play a significant parenting role for the child enrolled in the study, as a parent, grandparent, other relative, legal guardian, or other household member.
Who cannot join
- Prisoners
- Decisionally-challenged adults
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Evaluation of an Optimized Intervention to Prevent Early Substance Use Among American Indian Youth: Examination of Expanded Impacts on Youth and Parents
Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult substance use. In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance abuse among adults.
Read the detailed description
Study design overview
All 13 middle schools on the reservation will participate in this study by providing space for program groups to meet in the evenings and allowing recruitment activities at school events. A total of 480 families will be recruited into 6 cohorts across two years (spring, summer and fall). In each community, families with a child 10-12 years of age will be recruited to participate in the study. Half of recruited families will be randomly assigned to receive the Thiwáhe Gluwáš'akapi (TG) substance use prevention program and half to the comparison group, which will receive the Woyute Waśte (WW) healthy eating and exercise program. Randomization will be explained to families as part of the recruitment and consent process. Given the potential for contamination across groups with this design, the investigators will carefully examine outcomes across groups and statistically control for contamination effects as necessary. Alternative designs, including randomization at the school/community level, were rejected due to greater concerns about cross-community variability.
Recruitment and retention strategies
Schools (e.g., registration, family nights, parent-teacher conferences, holiday events) will be the main points of recruitment but additional advertising and promotion will take place at community events such as powwows, health fairs, and basketball tournaments. Written materials about the program will be distributed, along with promotional items (e.g., water bottles, magnets, and lanyards with the project name and logo). The investigators will also advertise on local community radio, which has wide reach on the reservation. Because TG has been implemented at 12 of the 13 middle schools on the reservation as a part of the adaptation study and has been well received by both families and school staff, the investigators often have inquiries about opportunities for future participation, and anticipate a positive response to recruitment efforts.
Facilitators will call families weekly to touch base with them and remind them about upcoming sessions. The investigators provide meals to families at the start of each program session, giving them opportunities to connect with other families and facilitators, fostering relationships, and making it easier for busy families to get to the sessions. Child care and transportation will be provided, as needed.
Approaches to ensuring fidelity
All facilitators will be trained in TG by a master SFP 10-14 trainer from Iowa State University (Beth Fleming) and the master TG trainer (Dr. Alicia Mousseau, who led the program adaptation). Weekly supervision and preparation for sessions before and during implementation will be provided onsite by local staff certified as TG trainers, who will also train new facilitators as needed due to staff turnover. These on-site trainers will also conduct regular fidelity checks (observations during sessions using standardized fidelity checklists) and provide feedback to facilitators.
Data collection schedule and estimated sample sizes across waves
In each family, up to 2 eligible youth (aged 10-12) and 1 parent/caregiver will be eligible to participate in the research and take study surveys. Sample size estimates for each wave are estimates of the number of families (F), youth (Y), adults (A), and total sample (T). Ranges for youth and total reflect that 1-2 youth per family are eligible to complete surveys. Estimates include an attrition rate of 2.5% every 6 months, based on past experience with families in this community.
- Baseline - 1-2 weeks before first session: F=480; Y=480-960; A=480; T=960-1440
- Post-intervention -1 week after last session: F=480; Y=480-960; A=480; T=960-1440 6 follow-up surveys:
- 6-month: F=468; Y=468-936; A=468; T=936-1404
- 12-month: F=456; Y=456-912; A=456; T=912-1368
- 18-month: F=445; Y=445-890; A=445; T=890-1335
- 24-month: F=434; Y=434-868; A=434; T=868-1302
- 30-month (excluding final cohort): F=370; Y=370-740; A=370; T=740-1110
- 36-month (excluding final 2 cohorts): F=206; Y=206-412; A=206; T=412-618
Data collection procedures
All surveys will be administered online, using REDCap survey software. The baseline survey will be collected during an in-person meeting, after consent is obtained, using iPads provided by research staff. Post-intervention surveys will also be administered in person. For follow-up surveys, participants will be sent unique links to access their surveys on their own devices (e.g., computers, phones, tablets) or at a location of their choice (e.g., tribal college center). They will also be able to request to have research staff meet with them to collect these follow-up surveys in person and provide a project iPad for survey completion. Surveys collected via REDCap will be immediately uploaded to a secure cloud storage. REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap is hosted by the University of Colorado Anschutz Medical Campus and supported by the Colorado Clinical and Translational Sciences Institute.
Analytic Plan
Three analytic approaches will be used: (1) discrete-time time survival analysis (DTSA), (2) mixed model analyses (MM), and (3) latent growth curve modeling (LGCM). Intention to treat principles will be applied in all analyses. Participant sex will be included as a covariate or separate models will be estimated by gender to explore differential effect patterns. Sandwich-estimators (type=complex in Mplus) and random effects models (in SAS Proc Mixed) will adjust for clustering at the family (and/or school) level. Full information maximum likelihood (FIML) procedures will be used to provide unbiased and efficient estimates.
Discrete-time survival analyses (DTSA) will be used to estimate the probability (hazard) for initiation of substance use among youth who have not used substances prior to enrollment in the study. Initial DTSA analyses will compare the fit of models assuming proportional odds (i.e., constant intervention effect across waves) either with or without frailty (residual variance) to non-proportional odds (i.e., variable intervention effect across waves). Comparisons will be based on the Akaike Information Criterion (AIC) and the Bayesian Information Criterion (BIC). Exposure to TG will be included as a time-invariant covariate to estimate treatment effects on risk of initiation. Mplus Monte Carlo analyses were used to determine power requirements for DTSA models. Effect-size estimates from earlier etiological work in this reservation community were used (hazard age 10-13, alcohol =.14; marijuana = .13, tobacco = .31). Estimated power to detect a moderate treatment effect - 20% reduction in risk of initiation - exceeded 80% across all effect-size specifications tested.
Mixed model analyses (MM) will be used to examine effects on all outcomes, including primary outcomes (youth substance use and suicide, adult substance use) and secondary outcomes (proximal mediators of risk for primary outcomes). MM analyses will account for correlated observations within participants over time and examine intervention effects averaged across the entire post-program data collection period and at each post-program assessment point individually. Wave of data collection and Condition (TG or WW) X Wave interaction will be fixed effects. Time will be a repeated measures factor and study participant and family cluster will be included as random effects. After verifying that randomization yielded baseline equivalence across Conditions, the investigators will use either linear (ordinal/continuous outcomes) or generalized linear mixed models (dichotomous outcomes) to test Condition X Wave interactions. The overall difference between TG and WW groups across the follow-up period compared to baseline will be obtained by calculating the average of all 7 Condition X Wave interaction effects. These analyses will test hypotheses about immediate and sustained effects of intervention exposures on outcomes. Power estimates for MM analyses were calculated using GLIMMPSE software, specifying estimates of substance use at each wave derived from previous work with this population. Analyses indicate that the projected sample size will be sufficient to detect a small to moderate intervention effect - 20% reduction in substance use across time - with power greater than .80.
The final analytic approach will follow Muthén \& Curran, estimating linear latent growth curve models (LGCM) to assess the effect of TG on outcome trajectories. The investigators will estimate the 'normative' trajectory of each outcome in the WW (comparison) group and the comparable trajectory in the TG (intervention) group. In the third step, the investigators will compare these trajectories and to determine whether there is a statistically significant change in the outcome trajectory related to TG intervention exposure. Finally, the investigators will evaluate the interaction between intervention exposure and initial level of the outcome to explore differential intervention effectiveness as a function of baseline levels for each outcome. Mplus Monte Carlo analyses were used to estimate power requirements for LGCM models and effect-size estimates were drawn from earlier etiological research. The power to detect slopes ranging from .14 to 1.4, were tested, estimating intercepts low (.05) consistent with our earlier findings and the young age of our study sample, setting alpha at .05, within each Condition group (TG treatment and WW comparison). Power estimates exceeded .90 to detect slope effects in all models.
- Conditions
- Substance Use, Substance Abuse, Suicide
- Being tested
- Thiwáhe Gluwáš'akapi, Woyute Waśte
- Keywords
- American Indian, Adolescent, Parenting, Family, Prevention
- Medical subject headings
- Substance-Related Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiwáhe Gluwáš'akapiBehavioural
Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong) is a cultural adaptation of the Strengthening Families Program for Parents and Youth 10-14 (SFP 10-14). TG, like SFP 10-14, is a 7-week family-based prevention program with separate youth and adult sessions followed by family sessions. Videos teach content and spark discussion; games and activities foster interaction and provide opportunities to practice skills. Four key adaptations were made to create TG: (1) cultural kinship teachings and tribal language kinship words were embedded throughout; (2) a parent session on coping with stress was enhanced to teach recognizing and responding to trauma reactions in youth; (3) a session on listening was moved earlier in the curriculum, given cultural oral tradition; (4) session videos were remade with local actors and adapted scenarios. A multiphase optimization strategy design was used to test potential adaptations, resulting in the optimized TG program.
Woyute WaśteBehavioural
Woyute Waśte (WW) was adapted from the Colorado School of Public Health's Integrated Nutrition Education Program (INEP) for the culture and context of the reservation. Families will meet for 1 session to participate in hands-on activities - preparing healthy meals, family physical activity, and sugary drinks. They will discuss setting healthy goals and tracking progress, receive recipes and water bottles, and for 6 weeks after the session, will get text messages with additional program content.
| Study group | Role | What they receive |
|---|---|---|
| Thiwáhe Gluwáš'akapi | Experimental | Weeks 1-7: Weekly in-person 2.5 hour family sessions 30 minute family meal 1 hour separate youth and adult sessions
1 hour family session Receives: Behavioral: Thiwáhe Gluwáš'akapi |
| Woyute Waśte | Active comparator | Respect for community and cultural values regarding research protocols precluded use of a randomized controlled design with a control group receiving no intervention, so we identified a cost-effective comparison condition program to offer value to study participants. A focus on healthy eating and exercise was of interest to community partners and not expected to directly confound the primary outcomes of the TG program (substance use and suicide risk).
Week 1 in-person 2.5 hour family session 30 minute family meal 2 hour interactive family session (3 stations) Weeks 2-7: text messages with program content and questions Receives: Behavioral: Woyute Waśte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lifetime alcohol use
Percentage reporting lifetime alcohol use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Alcohol initiation
Age of first reported alcohol use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of any alcohol use
Trajectory of frequency of past month alcohol use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month frequency of consumption of 4+ (for females) or 5+ (for males) alcoholic drinks at one time
Trajectory of frequency of past month alcohol consumption of 4+ drinks (for females) or 5+ (for males) (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month usual quantity of alcohol use [adults only]
Trajectory of usual quantity of alcohol use in past month (# drinks, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime alcohol intoxication
Percentage reporting lifetime alcohol intoxication (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Alcohol intoxication initiation
Age of first reported alcohol intoxication
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of intoxication
Trajectory of frequency of past month alcohol intoxication (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime use of cough syrup (without parental permission) [youth only]
Percentage reporting use of cough syrup (without parental permission) (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Cough syrup use initiation (without parental permission) [youth only]
Age of first reported non-medical cough syrup use
Measured: Up to 16 years of age
Past month frequency of use of cough syrup without parental permission [youth only]
Trajectory of frequency of past month use of cough syrup without parental permission (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month quantity of use of cough syrup without parental permission [youth only]
Trajectory of quantity of past month cough syrup used without parental permission (1 or 2 teaspoons (0); ¼ of the bottle (1); ½ of the bottle (2); One whole bottle (3); More than one bottle (4); measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime marijuana use
Percentage reporting lifetime marijuana use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Marijuana initiation
Age of first reported marijuana use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of marijuana use
Trajectory of frequency of past month marijuana use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime cigarette use
Percentage reporting lifetime cigarette use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Cigarette initiation
Age of first reported cigarette use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of cigarette use
Trajectory of frequency of past month cigarette use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime use of electronic vapor products
Percentage reporting use of electronic vapor products (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Electronic vapor products initiation
Age of first reported electronic vapor product use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of electronic vapor product use
Trajectory of frequency of past month electronic vapor product use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime chewing tobacco use
Percentage reporting chewing tobacco use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Chewing tobacco initiation
Age of first reported chewing tobacco use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of chewing tobacco use
Trajectory of frequency of past month chewing tobacco use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime inhalant use
Percentage reporting inhalant use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Inhalant use initiation
Age of first reported inhalant use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Past month frequency of inhalant use
Trajectory of frequency of past month inhalant use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
Percentage reporting non-medical use of prescription pain medicine (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Prescription pain medicine use (non-medical) initiation
Age of first reported non-medical prescription pain medicine use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Lifetime frequency of prescription pain medicine use without a prescription or other than as prescribed [adults only]
Trajectory of frequency of lifetime non-medical pain medicine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month frequency of prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
Trajectory of frequency of past month non-medical prescription pain medicine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime cocaine use [youth aged 13+ and adults only]
Percentage cocaine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Cocaine use initiation
Age of first reported cocaine use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Lifetime frequency of cocaine use [adults only]
Trajectory of frequency of lifetime cocaine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month frequency of cocaine use [youth aged 13+ and adults only]
Trajectory of frequency of past month cocaine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime methamphetamine use [youth aged 13+ and adults only]
Percentage methamphetamine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Methamphetamine use initiation
Age of first reported methamphetamine use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Lifetime frequency of methamphetamine use [adults only]
Trajectory of frequency of lifetime methamphetamine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month frequency of methamphetamine use [youth aged 13+ and adults only]
Trajectory of frequency of past month methamphetamine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime heroin use [adults only]
Percentage heroin use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Heroin use initiation
Age of first reported heroin use
Measured: Up to 16 years of age for youth; up to 30 years for adults
Lifetime frequency of heroin use [youth aged 13+ and adults only]
Trajectory of frequency of lifetime heroin use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past month frequency of heroin use [youth aged 13+ and adults only]
Trajectory of frequency of past month heroin use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Lifetime suicidal ideation [youth only]
Youth Risk Behavior Survey, middle school version, adapted to lifetime (ever seriously thought about suicide, ever made a plan, ever attempted); scored 0 to 3.
Measured: Change from baseline to 36 months after intervention
Past month suicidal ideation [youth only]
Youth Risk Behavior Survey items adapted to past month time frame; Middle school version for youth up to age 12 (scored 0-3); High school version for youth aged 13+ (scored 0-8).
Measured: Change from baseline to 36 months after intervention
Secondary outcomes (32)
Parent communication about alcohol and drugs [youth and adult reports]
Trajectory of change in mean reports of communication (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parent rules about substance use [youth and adult reports]
Trajectory of change in mean reports of setting rules about substance use (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Substance use attitudes [youth only]
Trajectory of change in mean reports of attitudes (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Substance use norms [youth only]
Trajectory of change in mean reports of norms (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Antisocial behavior [youth only]
Trajectory of change in mean reports of behaviors (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Association with deviant peers [youth only]
Trajectory of change in mean reports of association (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Substance use resistance skills [youth only]
Trajectory of change in mean reports of skills (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Substance use patterns (use of substances around children) [adults only]
Trajectory of change in mean reports of patterns (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Children's Hope Scale [youth only]
Trajectory of change in mean scores, range 1-6, higher scores represent greater hope (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Awareness of Connectedness scale (adapted) [youth only]
Trajectory of change in mean scores, range 1-5, higher scores represent greater connectedness (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Past week depression [youth only]
Trajectory of change in mean scores, range 1-4, higher scores represent greater depression (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family cohesion [adult reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater cohesion (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family cohesion [youth reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater cohesion (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family conflict [adult reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater conflict (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family conflict [youth reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater conflict (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family expressiveness [adult reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater expressiveness (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Family expressiveness [youth reports]
Trajectory of change in mean score, range 1-5, higher scores represent greater expressiveness (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Use of family meetings [adult reports only]
Trajectory of change in mean reports of use of family meetings (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
General parent-child communication [adult reports]
Trajectory of change in mean reports of communication (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
General parent-child communication [youth reports]
Trajectory of change in mean reports of communication (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parent warmth [adult reports]
Trajectory of change in mean reports of warmth (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parent warmth [youth reports]
Trajectory of change in mean reports of warmth (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parent negative affect [youth reports]
Trajectory of change in mean reports of negative affect (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parent negative affect [adult reports]
Trajectory of change in mean reports of negative affect (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental monitoring [youth reports]
Trajectory of change in mean reports of monitoring (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental structure/rule setting [adult reports]
Trajectory of change in mean reports (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental structure/rule setting [youth reports]
Trajectory of change in mean reports (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental support of autonomy [youth report only]
Trajectory of change in mean reports of support (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental use of discipline [adult report only]
Trajectory of change in mean reports of discipline (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parental anger management [adult report only]
Trajectory of change in mean reports of anger management (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Support for parenting [adult report only]
Trajectory of change in mean reports of support (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Parenting self-efficacy [adult report only]
Trajectory of change in mean reports of self-efficacy (measured at baseline, post-test, and 6 month intervals for 36 months)
Measured: Change from baseline to 36 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start26 Feb 2020
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Nancy R Whitesell, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222556
- Sponsor's protocol ID
- 18-2559
- Other IDs
- R37DA047926
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2019
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study, conducted on an American Indian reservation, is under the oversight of the tribal Research Review Board (RRB). Representing a sovereign tribal nation, the RRB asserts ownership of data and limits how data can be used and shared. To ensure compliance with RRB requirements, the Data Access Committee (DAC) at the Centers for American Indian and Alaska Native Health at the University of Colorado Anschutz Medical Campus will manage data access. The DAC has a detailed process to ensure compliance with RRB protocol. Users will be required to sign data use agreements stipulating commitment to: 1) abide by all tribal research review requirements, including obtaining approval for secondary analysis before accessing data and following review procedures for dissemination; 2) use data only for approved research; 3) protect individual and, if relevant, community confidentiality; 4) secure data using appropriate computer technology; 5) destroy or return data after analyses are complete.
Publications
Ivanich JD, Mousseau AC, Walls M, Whitbeck L, Whitesell NR. Pathways of Adaptation: Two Case Studies with One Evidence-Based Substance Use Prevention Program Tailored for Indigenous Youth. Prev Sci. 2020 Jan;21(Suppl 1):43-53. doi: 10.1007/s11121-018-0914-5.
PubMed 29876790Whitesell NR, Mousseau AC, Keane EM, Asdigian NL, Tuitt N, Morse B, Zacher T, Dick R, Mitchell CM, Kaufman CE. Integrating Community-Engagement and a Multiphase Optimization Strategy Framework: Adapting Substance Use Prevention for American Indian Families. Prev Sci. 2019 Oct;20(7):1136-1146. doi: 10.1007/s11121-019-01036-y.
PubMed 31376058
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Optimized Intervention to Prevent Early Substance Use Among American Indian Youth: Examination of Expanded Impacts on Youth and Parents
- ClinicalTrials.gov ID
- NCT04222556
- Acronym / sponsor ID
- 18-2559
- Conditions
- Substance Use, Substance Abuse, Suicide
- Keywords
- American Indian, Adolescent, Parenting, Family, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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.
Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult substance use. In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance abuse among adults.
Detailed description
Study design overview
All 13 middle schools on the reservation will participate in this study by providing space for program groups to meet in the evenings and allowing recruitment activities at school events. A total of 480 families will be recruited into 6 cohorts across two years (spring, summer and fall). In each community, families with a child 10-12 years of age will be recruited to participate in the study. Half of recruited families will be randomly assigned to receive the Thiwáhe Gluwáš'akapi (TG) substance use prevention program and half to the comparison group, which will receive the Woyute Waśte (WW) healthy eating and exercise program. Randomization will be explained to families as part of the recruitment and consent process. Given the potential for contamination across groups with this design, the investigators will carefully examine outcomes across groups and statistically control for contamination effects as necessary. Alternative designs, including randomization at the school/community level, were rejected due to greater concerns about cross-community variability.
Recruitment and retention strategies
Schools (e.g., registration, family nights, parent-teacher conferences, holiday events) will be the main points of recruitment but additional advertising and promotion will take place at community events such as powwows, health fairs, and basketball tournaments. Written materials about the program will be distributed, along with promotional items (e.g., water bottles, magnets, and lanyards with the project name and logo). The investigators will also advertise on local community radio, which has wide reach on the reservation. Because TG has been implemented at 12 of the 13 middle schools on the reservation as a part of the adaptation study and has been well received by both families and school staff, the investigators often have inquiries about opportunities for future participation, and anticipate a positive response to recruitment efforts.
Facilitators will call families weekly to touch base with them and remind them about upcoming sessions. The investigators provide meals to families at the start of each program session, giving them opportunities to connect with other families and facilitators, fostering relationships, and making it easier for busy families to get to the sessions. Child care and transportation will be provided, as needed.
Approaches to ensuring fidelity
All facilitators will be trained in TG by a master SFP 10-14 trainer from Iowa State University (Beth Fleming) and the master TG trainer (Dr. Alicia Mousseau, who led the program adaptation). Weekly supervision and preparation for sessions before and during implementation will be provided onsite by local staff certified as TG trainers, who will also train new facilitators as needed due to staff turnover. These on-site trainers will also conduct regular fidelity checks (observations during sessions using standardized fidelity checklists) and provide feedback to facilitators.
Data collection schedule and estimated sample sizes across waves
In each family, up to 2 eligible youth (aged 10-12) and 1 parent/caregiver will be eligible to participate in the research and take study surveys. Sample size estimates for each wave are estimates of the number of families (F), youth (Y), adults (A), and total sample (T). Ranges for youth and total reflect that 1-2 youth per family are eligible to complete surveys. Estimates include an attrition rate of 2.5% every 6 months, based on past experience with families in this community.
- Baseline - 1-2 weeks before first session: F=480; Y=480-960; A=480; T=960-1440
- Post-intervention -1 week after last session: F=480; Y=480-960; A=480; T=960-1440 6 follow-up surveys:
- 6-month: F=468; Y=468-936; A=468; T=936-1404
- 12-month: F=456; Y=456-912; A=456; T=912-1368
- 18-month: F=445; Y=445-890; A=445; T=890-1335
- 24-month: F=434; Y=434-868; A=434; T=868-1302
- 30-month (excluding final cohort): F=370; Y=370-740; A=370; T=740-1110
- 36-month (excluding final 2 cohorts): F=206; Y=206-412; A=206; T=412-618
Data collection procedures
All surveys will be administered online, using REDCap survey software. The baseline survey will be collected during an in-person meeting, after consent is obtained, using iPads provided by research staff. Post-intervention surveys will also be administered in person. For follow-up surveys, participants will be sent unique links to access their surveys on their own devices (e.g., computers, phones, tablets) or at a location of their choice (e.g., tribal college center). They will also be able to request to have research staff meet with them to collect these follow-up surveys in person and provide a project iPad for survey completion. Surveys collected via REDCap will be immediately uploaded to a secure cloud storage. REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap is hosted by the University of Colorado Anschutz Medical Campus and supported by the Colorado Clinical and Translational Sciences Institute.
Analytic Plan
Three analytic approaches will be used: (1) discrete-time time survival analysis (DTSA), (2) mixed model analyses (MM), and (3) latent growth curve modeling (LGCM). Intention to treat principles will be applied in all analyses. Participant sex will be included as a covariate or separate models will be estimated by gender to explore differential effect patterns. Sandwich-estimators (type=complex in Mplus) and random effects models (in SAS Proc Mixed) will adjust for clustering at the family (and/or school) level. Full information maximum likelihood (FIML) procedures will be used to provide unbiased and efficient estimates.
Discrete-time survival analyses (DTSA) will be used to estimate the probability (hazard) for initiation of substance use among youth who have not used substances prior to enrollment in the study. Initial DTSA analyses will compare the fit of models assuming proportional odds (i.e., constant intervention effect across waves) either with or without frailty (residual variance) to non-proportional odds (i.e., variable intervention effect across waves). Comparisons will be based on the Akaike Information Criterion (AIC) and the Bayesian Information Criterion (BIC). Exposure to TG will be included as a time-invariant covariate to estimate treatment effects on risk of initiation. Mplus Monte Carlo analyses were used to determine power requirements for DTSA models. Effect-size estimates from earlier etiological work in this reservation community were used (hazard age 10-13, alcohol =.14; marijuana = .13, tobacco = .31). Estimated power to detect a moderate treatment effect - 20% reduction in risk of initiation - exceeded 80% across all effect-size specifications tested.
Mixed model analyses (MM) will be used to examine effects on all outcomes, including primary outcomes (youth substance use and suicide, adult substance use) and secondary outcomes (proximal mediators of risk for primary outcomes). MM analyses will account for correlated observations within participants over time and examine intervention effects averaged across the entire post-program data collection period and at each post-program assessment point individually. Wave of data collection and Condition (TG or WW) X Wave interaction will be fixed effects. Time will be a repeated measures factor and study participant and family cluster will be included as random effects. After verifying that randomization yielded baseline equivalence across Conditions, the investigators will use either linear (ordinal/continuous outcomes) or generalized linear mixed models (dichotomous outcomes) to test Condition X Wave interactions. The overall difference between TG and WW groups across the follow-up period compared to baseline will be obtained by calculating the average of all 7 Condition X Wave interaction effects. These analyses will test hypotheses about immediate and sustained effects of intervention exposures on outcomes. Power estimates for MM analyses were calculated using GLIMMPSE software, specifying estimates of substance use at each wave derived from previous work with this population. Analyses indicate that the projected sample size will be sufficient to detect a small to moderate intervention effect - 20% reduction in substance use across time - with power greater than .80.
The final analytic approach will follow Muthén \& Curran, estimating linear latent growth curve models (LGCM) to assess the effect of TG on outcome trajectories. The investigators will estimate the 'normative' trajectory of each outcome in the WW (comparison) group and the comparable trajectory in the TG (intervention) group. In the third step, the investigators will compare these trajectories and to determine whether there is a statistically significant change in the outcome trajectory related to TG intervention exposure. Finally, the investigators will evaluate the interaction between intervention exposure and initial level of the outcome to explore differential intervention effectiveness as a function of baseline levels for each outcome. Mplus Monte Carlo analyses were used to estimate power requirements for LGCM models and effect-size estimates were drawn from earlier etiological research. The power to detect slopes ranging from .14 to 1.4, were tested, estimating intercepts low (.05) consistent with our earlier findings and the young age of our study sample, setting alpha at .05, within each Condition group (TG treatment and WW comparison). Power estimates exceeded .90 to detect slope effects in all models.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thiwáhe Gluwáš'akapi | Experimental | Behavioral: Thiwáhe Gluwáš'akapiWeeks 1-7: Weekly in-person 2.5 hour family sessions 30 minute family meal 1 hour separate youth and adult sessions 1 hour family session |
| Woyute Waśte | Active comparator | Behavioral: Woyute WaśteRespect for community and cultural values regarding research protocols precluded use of a randomized controlled design with a control group receiving no intervention, so we identified a cost-effective comparison condition program to offer value to study participants. A focus on healthy eating and exercise was of interest to community partners and not expected to directly confound the primary outcomes of the TG program (substance use and suicide risk). Week 1 in-person 2.5 hour family session 30 minute family meal 2 hour interactive family session (3 stations) Weeks 2-7: text messages with program content and questions |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Youth participants:
- Adult participants:
Key exclusion criteria (2 listed)
- Prisoners
- Decisionally-challenged adults
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 |
|---|---|---|
| Thiwáhe Gluwáš'akapiThiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong) is a cultural adaptation of the Strengthening Families Program for Parents and Youth 10-14 (SFP 10-14). TG, like SFP 10-14, is a 7-week family-based prevention program with separate youth and adult sessions followed by family sessions. Videos teach content and spark discussion; games and activities foster interaction and provide opportunities to practice skills. Four key adaptations were made to create TG: (1) cultural kinship teachings and tribal language kinship words were embedded throughout; (2) a parent session on coping with stress was enhanced to teach recognizing and responding to trauma reactions in youth; (3) a session on listening was moved earlier in the curriculum, given cultural oral tradition; (4) session videos were remade with local actors and adapted scenarios. A multiphase optimization strategy design was used to test potential adaptations, resulting in the optimized TG program. | Behavioural | Thiwáhe Gluwáš'akapi |
| Woyute WaśteWoyute Waśte (WW) was adapted from the Colorado School of Public Health's Integrated Nutrition Education Program (INEP) for the culture and context of the reservation. Families will meet for 1 session to participate in hands-on activities - preparing healthy meals, family physical activity, and sugary drinks. They will discuss setting healthy goals and tracking progress, receive recipes and water bottles, and for 6 weeks after the session, will get text messages with additional program content. | Behavioural | Woyute Waśte |
Primary outcome
Lifetime alcohol use
Time frame: Change from baseline to 36 months after intervention
Percentage reporting lifetime alcohol use (measured at baseline, post-test, and 6 month intervals for 36 months)
Alcohol initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported alcohol use
Past month frequency of any alcohol use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of consumption of 4+ (for females) or 5+ (for males) alcoholic drinks at one time
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol consumption of 4+ drinks (for females) or 5+ (for males) (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month usual quantity of alcohol use [adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of usual quantity of alcohol use in past month (# drinks, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime alcohol intoxication
Time frame: Change from baseline to 36 months after intervention
Percentage reporting lifetime alcohol intoxication (measured at baseline, post-test, and 6 month intervals for 36 months)
Alcohol intoxication initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported alcohol intoxication
Past month frequency of intoxication
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month alcohol intoxication (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime use of cough syrup (without parental permission) [youth only]
Time frame: Change from baseline to 36 months after intervention
Percentage reporting use of cough syrup (without parental permission) (measured at baseline, post-test, and 6 month intervals for 36 months)
Cough syrup use initiation (without parental permission) [youth only]
Time frame: Up to 16 years of age
Age of first reported non-medical cough syrup use
Past month frequency of use of cough syrup without parental permission [youth only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month use of cough syrup without parental permission (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month quantity of use of cough syrup without parental permission [youth only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of quantity of past month cough syrup used without parental permission (1 or 2 teaspoons (0); ¼ of the bottle (1); ½ of the bottle (2); One whole bottle (3); More than one bottle (4); measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime marijuana use
Time frame: Change from baseline to 36 months after intervention
Percentage reporting lifetime marijuana use (measured at baseline, post-test, and 6 month intervals for 36 months)
Marijuana initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported marijuana use
Past month frequency of marijuana use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month marijuana use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime cigarette use
Time frame: Change from baseline to 36 months after intervention
Percentage reporting lifetime cigarette use (measured at baseline, post-test, and 6 month intervals for 36 months)
Cigarette initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported cigarette use
Past month frequency of cigarette use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month cigarette use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime use of electronic vapor products
Time frame: Change from baseline to 36 months after intervention
Percentage reporting use of electronic vapor products (measured at baseline, post-test, and 6 month intervals for 36 months)
Electronic vapor products initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported electronic vapor product use
Past month frequency of electronic vapor product use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month electronic vapor product use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime chewing tobacco use
Time frame: Change from baseline to 36 months after intervention
Percentage reporting chewing tobacco use (measured at baseline, post-test, and 6 month intervals for 36 months)
Chewing tobacco initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported chewing tobacco use
Past month frequency of chewing tobacco use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month chewing tobacco use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime inhalant use
Time frame: Change from baseline to 36 months after intervention
Percentage reporting inhalant use (measured at baseline, post-test, and 6 month intervals for 36 months)
Inhalant use initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported inhalant use
Past month frequency of inhalant use
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month inhalant use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Percentage reporting non-medical use of prescription pain medicine (measured at baseline, post-test, and 6 month intervals for 36 months)
Prescription pain medicine use (non-medical) initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported non-medical prescription pain medicine use
Lifetime frequency of prescription pain medicine use without a prescription or other than as prescribed [adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime non-medical pain medicine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month non-medical prescription pain medicine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime cocaine use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Percentage cocaine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Cocaine use initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported cocaine use
Lifetime frequency of cocaine use [adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime cocaine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of cocaine use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month cocaine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime methamphetamine use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Percentage methamphetamine use (measured at baseline, post-test, and 6 month intervals for 36 months)
Methamphetamine use initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported methamphetamine use
Lifetime frequency of methamphetamine use [adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime methamphetamine use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of methamphetamine use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month methamphetamine use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime heroin use [adults only]
Time frame: Change from baseline to 36 months after intervention
Percentage heroin use (measured at baseline, post-test, and 6 month intervals for 36 months)
Heroin use initiation
Time frame: Up to 16 years of age for youth; up to 30 years for adults
Age of first reported heroin use
Lifetime frequency of heroin use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of lifetime heroin use (# times, measured at baseline, post-test, and 6 month intervals for 36 months)
Past month frequency of heroin use [youth aged 13+ and adults only]
Time frame: Change from baseline to 36 months after intervention
Trajectory of frequency of past month heroin use (# days, measured at baseline, post-test, and 6 month intervals for 36 months)
Lifetime suicidal ideation [youth only]
Time frame: Change from baseline to 36 months after intervention
Youth Risk Behavior Survey, middle school version, adapted to lifetime (ever seriously thought about suicide, ever made a plan, ever attempted); scored 0 to 3.
Past month suicidal ideation [youth only]
Time frame: Change from baseline to 36 months after intervention
Youth Risk Behavior Survey items adapted to past month time frame; Middle school version for youth up to age 12 (scored 0-3); High school version for youth aged 13+ (scored 0-8).
32 secondary outcomes
Parent communication about alcohol and drugs [youth and adult reports]
Time frame: Change from baseline to 36 months after intervention
Parent rules about substance use [youth and adult reports]
Time frame: Change from baseline to 36 months after intervention
Substance use attitudes [youth only]
Time frame: Change from baseline to 36 months after intervention
Substance use norms [youth only]
Time frame: Change from baseline to 36 months after intervention
Antisocial behavior [youth only]
Time frame: Change from baseline to 36 months after intervention
Association with deviant peers [youth only]
Time frame: Change from baseline to 36 months after intervention
Substance use resistance skills [youth only]
Time frame: Change from baseline to 36 months after intervention
Substance use patterns (use of substances around children) [adults only]
Time frame: Change from baseline to 36 months after intervention
Children's Hope Scale [youth only]
Time frame: Change from baseline to 36 months after intervention
Awareness of Connectedness scale (adapted) [youth only]
Time frame: Change from baseline to 36 months after intervention
Past week depression [youth only]
Time frame: Change from baseline to 36 months after intervention
Family cohesion [adult reports]
Time frame: Change from baseline to 36 months after intervention
Family cohesion [youth reports]
Time frame: Change from baseline to 36 months after intervention
Family conflict [adult reports]
Time frame: Change from baseline to 36 months after intervention
Family conflict [youth reports]
Time frame: Change from baseline to 36 months after intervention
Family expressiveness [adult reports]
Time frame: Change from baseline to 36 months after intervention
Family expressiveness [youth reports]
Time frame: Change from baseline to 36 months after intervention
Use of family meetings [adult reports only]
Time frame: Change from baseline to 36 months after intervention
General parent-child communication [adult reports]
Time frame: Change from baseline to 36 months after intervention
General parent-child communication [youth reports]
Time frame: Change from baseline to 36 months after intervention
Parent warmth [adult reports]
Time frame: Change from baseline to 36 months after intervention
Parent warmth [youth reports]
Time frame: Change from baseline to 36 months after intervention
Parent negative affect [youth reports]
Time frame: Change from baseline to 36 months after intervention
Parent negative affect [adult reports]
Time frame: Change from baseline to 36 months after intervention
Parental monitoring [youth reports]
Time frame: Change from baseline to 36 months after intervention
Parental structure/rule setting [adult reports]
Time frame: Change from baseline to 36 months after intervention
Parental structure/rule setting [youth reports]
Time frame: Change from baseline to 36 months after intervention
Parental support of autonomy [youth report only]
Time frame: Change from baseline to 36 months after intervention
Parental use of discipline [adult report only]
Time frame: Change from baseline to 36 months after intervention
Parental anger management [adult report only]
Time frame: Change from baseline to 36 months after intervention
Support for parenting [adult report only]
Time frame: Change from baseline to 36 months after intervention
Parenting self-efficacy [adult report only]
Time frame: Change from baseline to 36 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 29876790Ivanich JD, Mousseau AC, Walls M, Whitbeck L, Whitesell NR. Pathways of Adaptation: Two Case Studies with One Evidence-Based Substance Use Prevention Program Tailored for Indigenous Youth. Prev Sci. 2020 Jan;21(Suppl 1):43-53. doi: 10.1007/s11121-018-0914-5.
- Background: PubMed 31376058Whitesell NR, Mousseau AC, Keane EM, Asdigian NL, Tuitt N, Morse B, Zacher T, Dick R, Mitchell CM, Kaufman CE. Integrating Community-Engagement and a Multiphase Optimization Strategy Framework: Adapting Substance Use Prevention for American Indian Families. Prev Sci. 2019 Oct;20(7):1136-1146. doi: 10.1007/s11121-019-01036-y.
- Individual participant dataSharing planned: Yes. This study, conducted on an American Indian reservation, is under the oversight of the tribal Research Review Board (RRB). Representing a sovereign tribal nation, the RRB asserts ownership of data and limits how data can be used and shared. To ensure compliance with RRB requirements, the Data Access Committee (DAC) at the Centers for American Indian and Alaska Native Health at the University of Colorado Anschutz Medical Campus will manage data access. The DAC has a detailed process to ensure compliance with RRB protocol. Users will be required to sign data use agreements stipulating commitment to: 1) abide by all tribal research review requirements, including obtaining approval for secondary analysis before accessing data and following review procedures for dissemination; 2) use data only for approved research; 3) protect individual and, if relevant, community confidentiality; 4) secure data using appropriate computer technology; 5) destroy or return data after analyses are complete.
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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 Thiwáhe Gluwáš'akapi and Woyute Waśte in people with Substance Use and Substance Abuse, 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 8 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. 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?
Results are not available in the source record.
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?
Lifetime alcohol use (time frame: Change from baseline to 36 months after intervention). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04222556, which also lists 2 linked publications.
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 22 Dec 2023.