Strengthening Hispanic Families Via NIDA

NCT ID: NCT03407742

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2017-12-01

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

CAPAS Youth Parenting Intervention

Group Type: EXPERIMENTAL

CAPAS Youth

Intervention Type: BEHAVIORAL

9-week parenting intervention

Wait-list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CAPAS Youth

9-week parenting intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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.

Exclusion Criteria

• Child Protective Services involvement due to confirmed child abuse or neglect
• History of diagnosis with any severe psychiatric disorder.

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Jose R Parra-Cardona

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose R Parra-Cardona, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

the University of Texas at Austin

Locations

Steve Hicks School of Social Work, the University of Texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

1K01DA036747

Identifier Type: NIH

Identifier Source: org_study_id

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