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CompletedNCT03407742Updated Jan 24, 2018

Strengthening Hispanic Families Via NIDA

An interventional study of CAPAS Youth in Adolescent Behavior and Parenting, sponsored by University of Texas at Austin. Completed at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by University of Texas at Austin · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jun 2015, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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. Implement a small randomized controlled trial (RCT) with the culturally adapted and web-enhanced version of the GenerationPMTO intervention.
  3. 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.

02

Conditions studied

  • Adolescent Behavior
  • Parenting

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03

In context

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's enrollment of 168 is close to the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Browse Adolescent Behavior studies →

Lead sponsor

University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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 conduct or oppositional defiant or substance use disorders
  • Documented sexual abuse.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Intervention

    CAPAS Youth Parenting Intervention

    Behavioral: CAPAS Youth

  • No intervention
    Wait-list control

    Participants allocated to this condition were offered the parenting intervention until all T2 assessments of the intervention arm were completed

Interventions

  • BehavioralCAPAS Youth

    9-week parenting intervention

06

What researchers measure

Primary outcomes

  1. Parenting Positive Involvement

    Measures quality of parenting practices aimed at improving parent-youth relationship. Scale 0-4, with lower scores indicating worse outcome.

    Time frame: Measured 4-5 months after T1 measurements

  2. 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.

    Time frame: Measured 4-5 months after T1 measurements

  3. Parenting Discipline

    Measures quality of parental limit setting skills. Scale 0-4 with lower score indicating worse outcome.

    Time frame: Measured 4-5 months after T1 measurements

  4. Parenting Supervision.

    Measures quality of parenting practices focused on monitoring and supervision. Scale 0-4 with lower score indicating worse outcome.

    Time frame: Measured 4-5 months after T1 measurements

  5. 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.

    Time frame: Measured 4-5 months after T1 measurements

  6. Adolescents' Perceived Risk of Drug Use

    Measures changes in youth's perception of drug use. Scale 0-4 with higher score indicating best outcome.

    Time frame: Measured 4-5 months after T1 measurements

  7. 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.

    Time frame: Measured 4-5 months after T1 measurements

  8. Revised Behavioral Problem checklist

    Measures youth's internalizing and externalizing problematic behaviors. Scale 0-2 with lower scores indicating worse outcomes.

    Time frame: Measured 4-5 months after T1 measurements

Secondary outcomes

  1. 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.

    Time frame: Measured 4-5 months after T1 measurements

  2. Hispanic Stress Inventory

    Measurements parental stress characteristic of Hispanic immigrant populations. Score 0-5 with higher scores indicating worse outcome.

    Time frame: Measure 4-5 months after T1 measurements

07

Study locations

1 site
  • Steve Hicks School of Social Work, the University of Texas at Austin
    Austin, Texas 78712, United States
08

References and documents

Individual participant data

Plan to share: Undecided — According to IRB regulations, no identifiable data will be shared, only aggregate data. However, the timing for sharing is not yet determined.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03407742
Responsible party
Jose R Parra-Cardona (Associate Professor, University of Texas at Austin) — Principal investigator
First posted
Jan 23, 2018
Start date
Jun 1, 2015
Primary completion
Aug 1, 2017
Completion
Dec 1, 2017
Last update
Jan 24, 2018

Study contacts

Jose R Parra-Cardona, Ph.D.
principal investigator · the University of Texas at Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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