Adolescent BehaviorNCT03407742
Strengthening Hispanic Families Via NIDA
A study testing CAPAS Youth in people with Adolescent Behavior and Parenting, run by University of Texas at Austin at 1 site in United States.
Trial summary
The proposed specific aims of this K01 pilot study were: 1. Develop a culturally adapted and web-enhanced version of the Parent Management Training-the Oregon model (GenerationPMTO) intervention for first generation Hispanic families with youth. 2. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Parenting
- What is being tested?
- CAPAS Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 Dec 2017
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Parent Inclusion Criteria:
- 18 years or older.
- Living in a one or two-parent family household.
- At least one parent self-identifies as foreign-born and first generation Hispanic/a immigrant, with one or more US-born 12-14 year old children in middle school.
- Spanish speaking.
- Provide written consent to participate in a parenting intervention trial.
- Have access to phone service in home and have home-based internet access.
- Report a combined annual family income is equal or lower than federal income guidelines for families eligible to receive federal welfare assistance.
Youth inclusion criteria:
- Age 12-14 years old.
- Attending middle school.
- Self-identified as Hispanic or Latino.
- English-, or Spanish-speaking, or bilingual.
- Parent report at least one externalizing problem behavior.
Parent Exclusion Criteria:
- Child Protective Services involvement due to confirmed child abuse or neglect
- History of diagnosis with any severe psychiatric disorder.
Focal Youth exclusion criteria:
- Hispanic validated version of Bird et al. screening test at 'high' level of problem behaviors.
- One or more of the DSM-IV-TR conduct or oppositional defiant or substance use disorders
- Documented sexual abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Steve Hicks School of Social Work, the University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Strengthening Hispanic Families Via NIDA Prevention Science
The proposed specific aims of this K01 pilot study were:
- Develop a culturally adapted and web-enhanced version of the Parent Management Training-the Oregon model (GenerationPMTO) intervention for first generation Hispanic families with youth.
- Implement a small randomized controlled trial (RCT) with the culturally adapted and web-enhanced version of the GenerationPMTO intervention.
- Systematically examine the implementation feasibility (i.e., rates of engagement, retention, and cultural acceptability) and initial efficacy of the adapted intervention (i.e., reduced parental stress and depression, increased quality of parenting skills, reduced levels of internalizing and externalizing behaviors in youth, and reduced adolescent substance use likelihood).
Read the detailed description
Recruitment. Participants were recruited according to eligibility criteria, in close collaboration with community partners. Specifically, health and mental health care centers, as well as community organizations and churches were targeted for recruitment activities. Recruitment also consisted of snowball recruitment from participants exposed to the intervention.
General Description of the Intervention. The Parent Management Training-Oregon model (GenerationPMTO) intervention is delivered primarily to parents in order to strengthen parenting skills in a safe learning environment that empower parents to implement these skills at home. The development of the original GenerationPMTO Spanish manual was conducted by Dr. Domenech-Rodriguez according to a comprehensive model of cultural adaptation research.
The intervention consisted of GenerationPMTO and culturally-focused sessions. The GenerationPMTO-focused sessions are detailed in the core treatment manual and have been translated into Spanish utilizing a rigorous process of translation and consultation with Hispanic scholars. Culturally-focused sessions integrated content from three sources. First, we informed sessions according to relevant literature focused on biculturalism. We also informed the intervention by addressing specific cultural themes that were identified as salient in our qualitative studies, which correspond to existing literature on risk and protective factors associated with Hispanic youth. Finally, parents were invited to reflect on additional cultural values and experiences that they consider relevant to their parenting efforts.
With regard to content of individual sessions, module 1 addressed issues associated with immigration, Hispanic culture, and bicultural frameworks. Module 2 addressed issues associated with parenting and biculturalism. Modules 3-6 covered the GenerationPMTO core components as they apply to adolescent populations. Module 7 consists of an in-person session to refine and troubleshoot parenting skills that parents may consider particularly challenging. To enhance the cultural relevance of GenerationPMTO components, we will present all GenerationPMTO parenting skills according to bicultural frameworks, a strategy highly effective the R34 study.
Modules 8-9 reinforced issues of biculturalism having exposed parents to all PMTO core components. A strong focus on biculturalism is particularly relevant as empirical research has demonstrated that the promotion of biculturalism constitutes an effective protective factor for Hispanic youth in first generation Hispanic families.
Randomization. The individual family was the unit of computer-derived randomization, with PTMO-control balance sought for (a) gender of target youth, and (b) time of recruitment. Assessments. Data collection was completed after recruitment (T1) and upon intervention completion (T2).
Intervention Delivery. The intervention was delivered in a major faith-based organization as this site was the preferred site selected by Latino/a parents. In addition to the parenting intervention, a strong advocacy approach was implemented to address various needs of parents (e.g., referral to job training programs or immigration services).
Analyses. Tests of the primary hypothesis will involve fitting of the more assumption-laden subject-specific multivariate response model to Likelihood of Youth Substance Use (LYUS) sub-scale values, followed by fitting of the somewhat more conservative Generalized Estimating Equations (GEE) marginal model with the advantage of fewer assumptions.Our papers will report crude and covariate-adjusted efficacy estimates from both models, allowing readers to draw inferences based on either or both approaches. These same models are used to test the secondary efficacy hypotheses about program impact on parenting skill levels, youth internalizing/externalizing behaviors, and parent stress levels.
- Conditions
- Adolescent Behavior, Parenting
- Being tested
- CAPAS Youth
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPAS YouthBehavioural
9-week parenting intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | CAPAS Youth Parenting Intervention Receives: Behavioral: CAPAS Youth |
| Wait-list control | No intervention | Participants allocated to this condition were offered the parenting intervention until all T2 assessments of the intervention arm were completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting Positive Involvement
Measures quality of parenting practices aimed at improving parent-youth relationship. Scale 0-4, with lower scores indicating worse outcome.
Measured: Measured 4-5 months after T1 measurements
Parenting Skills Encouragement
Measures quality of parenting practices aimed at motivating children's self-sufficient behaviors. Scale 0-4 with lower scores indicating worse outcomes.
Measured: Measured 4-5 months after T1 measurements
Parenting Discipline
Measures quality of parental limit setting skills. Scale 0-4 with lower score indicating worse outcome.
Measured: Measured 4-5 months after T1 measurements
Parenting Supervision.
Measures quality of parenting practices focused on monitoring and supervision. Scale 0-4 with lower score indicating worse outcome.
Measured: Measured 4-5 months after T1 measurements
Parenting Family Problem Solving
Measures quality of parenting practices aimed at helping youth develop problem solving skills. Scale 0-4 with lower score indicating worse outcome.
Measured: Measured 4-5 months after T1 measurements
Adolescents' Perceived Risk of Drug Use
Measures changes in youth's perception of drug use. Scale 0-4 with higher score indicating best outcome.
Measured: Measured 4-5 months after T1 measurements
Adolescents' Likelihood of Drug Use.
Measures likelihood of youth engaging in drug use. Scale 0-5 with higher score indicating best outcome. Scale 1-5 with higher score indicating worse outcome.
Measured: Measured 4-5 months after T1 measurements
Revised Behavioral Problem checklist
Measures youth's internalizing and externalizing problematic behaviors. Scale 0-2 with lower scores indicating worse outcomes.
Measured: Measured 4-5 months after T1 measurements
Secondary outcomes (2)
Bicultural Involvement Questionnaire
Measures level of acculturation in parents and youth. Scale 1-5. Lower scores indicate US oriented identity and high score indicate Latino-oriented identity.
Measured: Measured 4-5 months after T1 measurements
Hispanic Stress Inventory
Measurements parental stress characteristic of Hispanic immigrant populations. Score 0-5 with higher scores indicating worse outcome.
Measured: Measure 4-5 months after T1 measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jun 2015
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Parallel groups
- Model description
- Participants were randomized to one of two conditions: (a) intervention consisting of parenting program, or (b) wait-list control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Jose R Parra-Cardona, University of Texas at Austin
- Investigators
- Jose R Parra-Cardona, Ph.D., Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407742
- Sponsor's protocol ID
- 1K01DA036747
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2017
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: According to IRB regulations, no identifiable data will be shared, only aggregate data. However, the timing for sharing is not yet determined.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Hispanic Families Via NIDA Prevention Science
- ClinicalTrials.gov ID
- NCT03407742
- Acronym / sponsor ID
- 1K01DA036747
- Conditions
- Adolescent Behavior, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 23 Jan 2018 (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.
The proposed specific aims of this K01 pilot study were:
- Develop a culturally adapted and web-enhanced version of the Parent Management Training-the Oregon model (GenerationPMTO) intervention for first generation Hispanic families with youth.
- Implement a small randomized controlled trial (RCT) with the culturally adapted and web-enhanced version of the GenerationPMTO intervention.
- Systematically examine the implementation feasibility (i.e., rates of engagement, retention, and cultural acceptability) and initial efficacy of the adapted intervention (i.e., reduced parental stress and depression, increased quality of parenting skills, reduced levels of internalizing and externalizing behaviors in youth, and reduced adolescent substance use likelihood).
Detailed description
Recruitment. Participants were recruited according to eligibility criteria, in close collaboration with community partners. Specifically, health and mental health care centers, as well as community organizations and churches were targeted for recruitment activities. Recruitment also consisted of snowball recruitment from participants exposed to the intervention.
General Description of the Intervention. The Parent Management Training-Oregon model (GenerationPMTO) intervention is delivered primarily to parents in order to strengthen parenting skills in a safe learning environment that empower parents to implement these skills at home. The development of the original GenerationPMTO Spanish manual was conducted by Dr. Domenech-Rodriguez according to a comprehensive model of cultural adaptation research.
The intervention consisted of GenerationPMTO and culturally-focused sessions. The GenerationPMTO-focused sessions are detailed in the core treatment manual and have been translated into Spanish utilizing a rigorous process of translation and consultation with Hispanic scholars. Culturally-focused sessions integrated content from three sources. First, we informed sessions according to relevant literature focused on biculturalism. We also informed the intervention by addressing specific cultural themes that were identified as salient in our qualitative studies, which correspond to existing literature on risk and protective factors associated with Hispanic youth. Finally, parents were invited to reflect on additional cultural values and experiences that they consider relevant to their parenting efforts.
With regard to content of individual sessions, module 1 addressed issues associated with immigration, Hispanic culture, and bicultural frameworks. Module 2 addressed issues associated with parenting and biculturalism. Modules 3-6 covered the GenerationPMTO core components as they apply to adolescent populations. Module 7 consists of an in-person session to refine and troubleshoot parenting skills that parents may consider particularly challenging. To enhance the cultural relevance of GenerationPMTO components, we will present all GenerationPMTO parenting skills according to bicultural frameworks, a strategy highly effective the R34 study.
Modules 8-9 reinforced issues of biculturalism having exposed parents to all PMTO core components. A strong focus on biculturalism is particularly relevant as empirical research has demonstrated that the promotion of biculturalism constitutes an effective protective factor for Hispanic youth in first generation Hispanic families.
Randomization. The individual family was the unit of computer-derived randomization, with PTMO-control balance sought for (a) gender of target youth, and (b) time of recruitment. Assessments. Data collection was completed after recruitment (T1) and upon intervention completion (T2).
Intervention Delivery. The intervention was delivered in a major faith-based organization as this site was the preferred site selected by Latino/a parents. In addition to the parenting intervention, a strong advocacy approach was implemented to address various needs of parents (e.g., referral to job training programs or immigration services).
Analyses. Tests of the primary hypothesis will involve fitting of the more assumption-laden subject-specific multivariate response model to Likelihood of Youth Substance Use (LYUS) sub-scale values, followed by fitting of the somewhat more conservative Generalized Estimating Equations (GEE) marginal model with the advantage of fewer assumptions.Our papers will report crude and covariate-adjusted efficacy estimates from both models, allowing readers to draw inferences based on either or both approaches. These same models are used to test the secondary efficacy hypotheses about program impact on parenting skill levels, youth internalizing/externalizing behaviors, and parent stress levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized to one of two conditions: (a) intervention consisting of parenting program, or (b) wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: CAPAS YouthCAPAS Youth Parenting Intervention |
| Wait-list control | No intervention | –Participants allocated to this condition were offered the parenting intervention until all T2 assessments of the intervention arm were completed |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| CAPAS Youth9-week parenting intervention | Behavioural | Intervention |
Primary outcome
Parenting Positive Involvement
Time frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at improving parent-youth relationship. Scale 0-4, with lower scores indicating worse outcome.
Parenting Skills Encouragement
Time frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at motivating children's self-sufficient behaviors. Scale 0-4 with lower scores indicating worse outcomes.
Parenting Discipline
Time frame: Measured 4-5 months after T1 measurements
Measures quality of parental limit setting skills. Scale 0-4 with lower score indicating worse outcome.
Parenting Supervision.
Time frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices focused on monitoring and supervision. Scale 0-4 with lower score indicating worse outcome.
Parenting Family Problem Solving
Time frame: Measured 4-5 months after T1 measurements
Measures quality of parenting practices aimed at helping youth develop problem solving skills. Scale 0-4 with lower score indicating worse outcome.
Adolescents' Perceived Risk of Drug Use
Time frame: Measured 4-5 months after T1 measurements
Measures changes in youth's perception of drug use. Scale 0-4 with higher score indicating best outcome.
Adolescents' Likelihood of Drug Use.
Time frame: Measured 4-5 months after T1 measurements
Measures likelihood of youth engaging in drug use. Scale 0-5 with higher score indicating best outcome. Scale 1-5 with higher score indicating worse outcome.
Revised Behavioral Problem checklist
Time frame: Measured 4-5 months after T1 measurements
Measures youth's internalizing and externalizing problematic behaviors. Scale 0-2 with lower scores indicating worse outcomes.
2 secondary outcomes
Bicultural Involvement Questionnaire
Time frame: Measured 4-5 months after T1 measurements
Hispanic Stress Inventory
Time frame: Measure 4-5 months after T1 measurements
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 24 Jan 2018.
- Individual participant dataSharing planned: Undecided. According to IRB regulations, no identifiable data will be shared, only aggregate data. However, the timing for sharing is not yet determined.
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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.
Jose R Parra-Cardona, Ph.D. principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPAS Youth in people with Adolescent Behavior and Parenting, run by University of Texas at Austin 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?
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 24 Jan 2018. 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?
Parenting Positive Involvement (time frame: Measured 4-5 months after T1 measurements). The study lists 8 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 24 Jan 2018.