Clinical trial NCT05291481: Implementing a Church-based Parenting Intervention for Hispanics
Official title: Implementing a Church-based Parenting Intervention to Promote NIDA Prevention Science Among Hispanics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Parenting
Keywords: Parent Training
Cultural Adaptation
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 327
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CAPAS-Youth is a culturally adapted version of the evidence-based intervention known as GenerationPMTO, which was originally adapted with a majority of Euro-American populations. The initial efficacy of CAPAS-Youth has already been demonstrated in a previous study. The current investigation is focused on tailoring CAPAS-Youth for Hispanic immigrants in Texas.
Primary purpose: PREVENTION

Brief summary: The current investigation consists of the implementation and modest refinements of a culturally adapted version of the evidence-based PT intervention known as GenerationPMTO.© The adapted intervention, CAPAS-Youth, is primarily delivered to parents. The primary research objectives are twofold: a) to conduct refinements of the CAPAS-Youth intervention for Hispanic immigrants in mid-Texas, and b) to measure implementation barriers and precursors, as well as implementation outcomes, in an effort to inform a future study focused on scaling the intervention. A special focus on faith-based organization informs the intervention, as a way of increasing reach with underserved Hispanic immigrant communities.

Detailed description: Parent training (PT) interventions constitute the gold standard for strengthening parenting practices that are effective protective factors in the lives of adolescents. However, the availability of efficacious culturally adapted PT interventions in underserved Hispanic communities remains scarce throughout the US. Thus, there is an urgent need in the implementation science (IS) field to identify implementation strategies aimed at addressing service gaps affecting Hispanic populations. The current investigation consists of the implementation and modest refinements of a culturally adapted version of the evidence-based PT intervention known as GenerationPMTO.© Our rationale is that implementing efficacious prevention interventions in faith-based organizations constitutes a key alternative to address service barriers experienced by underserved populations. We also propose that by training lay members of target communities as prevention interventionists, the sustainment of prevention programs can be significantly enhanced. The research aims of this R34 investigation are: (a) To implement a pilot study aimed at refining the CAPAS-Youth curriculum and study procedures, (b) to implement a randomized controlled trial, aimed at empirically testing the efficacy of the CAPAS-Youth intervention with first-generation low-income Hispanic families in Travis County, (c) to measure barriers and facilitators associated with the implementation of the CAPAS-Youth prevention intervention in the target context, and (d) to measure relevant implementation outcomes to inform a future R01 effectiveness trial. The investigation has high public health relevance as it addresses health disparities experienced by populations not adequately served by existing systems of care.

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 immigrant, with one or more US-born 12-14 year old children.
* Spanish speaking.
* Provide written consent to participate in a parenting intervention trial.
* Report financial challenges/restrictions.

Youth inclusion criteria:

* 12-14 years old.
* 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 a severe psychiatric disorder.

Focal Youth exclusion criteria:

* Hispanic validated version of Bird et al. screening test at 'high' level of problem behaviors.
* Meets one or more of the DSM-IV-TR conduct or oppositional defiant or substance use disorders
* Active case of documented sexual abuse.

Primary outcomes:
measure: Family Problem Solving: change in problem solving skills from baseline to 9 months
timeFrame: Change from baseline problem solving skills to 9 months
measure: Parenting Encouragement Skills: change in parenting encouragement skills from baseline to 9 months
timeFrame: Change from baseline parenting encouragement skills to 9 months
measure: Parenting Positive Involvement Skills: change in parenting positive involvement skills from baseline to 9 months
timeFrame: Change from baseline parenting positive involvement skills to 9 months
measure: Parenting Discipline Skills: change in parenting discipline skills from baseline to 9 months
timeFrame: Change from baseline parenting discipline skills to 9 months
measure: Parenting Monitoring and Supervision Skills: change in parenting monitoring and discipline skills from baseline to 9 months
timeFrame: Change from baseline monitoring and supervision skills to 9 months
measure: Adolescent Perceived Risk of Drug Use: change in youths' perceived risk of drug use from baseline to 9 months
timeFrame: Change from baseline adolescents perceived risk of drug use to 9 months
measure: Adolescent Drug Use: change in youths' drug use from baseline to 9 months
timeFrame: Change from baseline adolescent drug use to 9 months
measure: Youth Problematic Behaviors - change in youths' problematic behaviors from baseline to 9 months
timeFrame: Change from baseline youth problematic behaviors to 9 months
Secondary outcomes:
measure: Bicultural Involvement: change in parents and youth acculturation from baseline to 9 months
timeFrame: Change from baseline parents and youth acculturation to 9 months
measure: Immigration-related Stress: change in parents' immigration related stress from baseline to 9 months
timeFrame: Change from baseline immigration-related stress to 9 months
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: