Clinical trial NCT03407742: Strengthening Hispanic Families Via NIDA
Official title: Strengthening Hispanic Families Via NIDA Prevention Science
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Parenting
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2018-01-23
Enrollment: 168
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to one of two conditions: (a) intervention consisting of parenting program, or (b) wait-list control group
Primary purpose: PREVENTION

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.

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 DSM-IV-TR conduct or oppositional defiant or substance use disorders
* Documented sexual abuse.

Primary outcomes:
measure: Parenting Positive Involvement
timeFrame: Measured 4-5 months after T1 measurements
measure: Parenting Skills Encouragement
timeFrame: Measured 4-5 months after T1 measurements
measure: Parenting Discipline
timeFrame: Measured 4-5 months after T1 measurements
measure: Parenting Supervision.
timeFrame: Measured 4-5 months after T1 measurements
measure: Parenting Family Problem Solving
timeFrame: Measured 4-5 months after T1 measurements
measure: Adolescents' Perceived Risk of Drug Use
timeFrame: Measured 4-5 months after T1 measurements
measure: Adolescents' Likelihood of Drug Use.
timeFrame: Measured 4-5 months after T1 measurements
measure: Revised Behavioral Problem checklist
timeFrame: Measured 4-5 months after T1 measurements
Secondary outcomes:
measure: Bicultural Involvement Questionnaire
timeFrame: Measured 4-5 months after T1 measurements
measure: Hispanic Stress Inventory
timeFrame: Measure 4-5 months after T1 measurements
Other outcomes:
Locations:
city: Austin
country: United States
facility: Steve Hicks School of Social Work, the University of Texas at Austin
state: Texas
Study officials:
affiliation: the University of Texas at Austin
name: Jose R Parra-Cardona, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: