Parent-Focused Alcohol Prevention Program for Hispanic Families in Faith-Based Settings

NCT07869550 | Not Yet Recruiting

• 2 other identifiers: STUDY00009687R34AA032397
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether Guiando Buenas Decisiones, a parent-focused alcohol prevention program, can help prevent or delay alcohol initiation and use among Hispanic immigrant adolescents ages 12 to 14 from low-income families. The study will also examine how well the program can be implemented through a faith-based community organization. The main questions this study aims to answer are:

1. 1.Does the refined Guiando Buenas Decisiones program help prevent or delay alcohol initiation and use among adolescents?
2. 2.Does the refined Guiando Buenas Decisiones program improve family, individual, and sociocultural risk and protective factors related to adolescent alcohol use, as reported by parents and adolescents?
3. 3.What individual- and organizational-level barriers and facilitators affect implementation of the refined Guiando Buenas Decisiones program?
4. 4.What are the reach, adoption, implementation, and maintenance outcomes of delivering the refined Guiando Buenas Decisiones program through a faith-based community organization?

Conditions

Alcohol Use; Underage Drinking; Parenting Intervention; Prevention; Faith-Based; Implementation Science

Keywords

Alcohol Prevention; Underage Drinking; Parenting Intervention; Guiando Buenas Decisiones; Family-Based Prevention; Faith-Based Organizations; Implementation Science; Prevention Science; Community Health Workers; Risk and Protective Factors; Hispanic Families

Outcome Measures

Primary Outcomes (5)

• Adolescent alcohol use initiation

  Target youth will complete adapted items from the National Institute on Drug Abuse-funded Monitoring the Future study, the Screening to Brief Intervention tool, and the National Longitudinal Survey of Youth. Youth will report whether they have ever used alcohol. The outcome will be measured as lifetime alcohol use initiation (yes/no) at each assessment.

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Adolescent past-year alcohol use frequency

  Target youth will report how frequently they used alcohol during the past 12 months using adapted items from the Monitoring the Future study and the Screening to Brief Intervention tool. Responses will assess the number of occasions on which alcohol was used during the past year.

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Adolescent past-year alcohol use quantity

  Target youth will report the quantity of alcohol consumed during the past 12 months using adapted items from the Monitoring the Future study and the National Longitudinal Survey of Youth. Responses will assess the number of alcoholic drinks typically consumed on occasions when alcohol was used during the past year.

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Adolescent past-30-day alcohol use frequency

  Target youth will report how frequently they used alcohol during the past 30 days using adapted items from the Monitoring the Future study and the Screening to Brief Intervention tool. Responses will assess the number of occasions on which alcohol was used during the past 30 days.

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Adolescent past-30-day alcohol use quantity

  Target youth will report the quantity of alcohol consumed during the past 30 days using adapted items from the Monitoring the Future study and the National Longitudinal Survey of Youth. Responses will assess the number of alcoholic drinks consumed on occasions when alcohol was used during the past 30 days.

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

Secondary Outcomes (15)

• Family risk and protective factors

  Baseline, post-intervention (7 weeks), 6 months post-intervention

• Perceived discrimination

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Perceived negative context of reception

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Language stress

  Baseline, post-intervention (7 weeks), and 6 months post-intervention

• Implementation outcome - Reach

  Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start

Study Arms (2)

Guiando Buenas Decisiones Intervention

EXPERIMENTAL

Families assigned to this arm receive the refined Guiando Buenas Decisiones program. The intervention consists of seven weekly sessions, each lasting approximately 2 hours, delivered to parents by trained community health workers and lay church members.

Behavioral: Guiando Buenas Decisiones (GBD)

Wait-List Control

NO INTERVENTION

Families assigned to this arm do not receive the Guiando Buenas Decisiones intervention during the randomized comparison period. They complete the same study assessments as the intervention group and are offered the refined Guiando Buenas Decisiones intervention after completion of the 6-month follow-up assessment.

Interventions

Guiando Buenas Decisiones (GBD) BEHAVIORAL

Guiando Buenas Decisiones (GBD) is the Spanish version of the U.S. evidence-based alcohol prevention intervention, Guiding Good Choices. GBD is exclusively for parents and aims to enhance parenting skills and foster positive parent-child bonding. The program includes five sessions, with an additional sixth session introduced in a Mexican adaptation focusing on reinforcing alcohol literacy and addressing alcohol expectancies. The refined GBD program to be piloted and tested in this study is informed by the Mexican adaptation and tailored for delivery among Hispanic (predominantly Mexican-origin) U.S. families with children ages 12-14. Refinements incorporate content relevant to the sociocultural realities experienced by U.S. Hispanic immigrant families, resulting in an additional introductory session.

Guiando Buenas Decisiones Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents:
• Being 18 years or older.
• Living in a one- or two-parent household.
• Self-identifying as Hispanic or Latino/a.
• Self-identifying as a foreign-born and first-generation Hispanic immigrant with one or more United States-born 12-14-year-old children.
• Spanish speaker.
• Provide written consent to participate in a parenting intervention trial and to be videotaped during parenting sessions.
• Combined annual family income that qualifies as "low-income," as defined by federal standards for households earning less than 200% of the federal poverty line.
• Children:
• Being United States-born or foreign-born.
• Aged 12-14 years.
• Self-identifying as Hispanic or Latino/a.
• Being English- or Spanish-speaking, or bilingual.
• Organizational Leaders, Managers, and Interventionists:
• Be affiliated with a faith-based or Hispanic-serving organization in Travis County.

You may not qualify if:

• Parents:
• Involvement with Child Protective Services (CPS) due to confirmed child abuse (e.g., physical or sexual abuse).
• Current diagnosis of a severe psychiatric disorder that hinders participation in a parenting program (e.g., schizophrenia).
• Children:
• Current CPS-documented abuse by the caregiver seeking to participate in the parenting program.
• Parent report of any intellectual, developmental, or cognitive impairment that would prevent them from understanding the purpose of the study, study measures, or the Guiando Buenas Decisiones curriculum, or if they reside outside of the United States.
• Organizational Leaders, Managers, and Interventionists:
• Lack experience working with Hispanic populations.
• Not expressing an interest to participate in this investigation in any of the aforementioned roles (i.e., organization leader, manager, interventionist).
• Refuse to provide written consent to participate in this investigation.
• Business or Strategic Funding Leaders:
• Not expressing an interest to participate in this study.
• Refuse to provide written consent to participate in this investigation.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• University of Washington, Social Development Research Group: collaborator
• University of Miami, Miami, United States: collaborator
• El Buen Samaritano: collaborator

Study Sites (1)

El Buen Samaritano

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Underage Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Adolescent Behavior

Study Officials

• Pablo Montero-Zamora

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Montero-Zamora

CONTACT

512-232-5846; pmontero@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study includes an initial single-group pilot phase followed by a two-arm parallel randomized controlled trial. In the randomized trial, families are assigned to either the refined Guiando Buenas Decisiones intervention or a wait-list control condition. Parents and adolescents complete assessments at baseline, immediately after the intervention, and 6 months after the intervention. Families assigned to the wait-list control condition are offered Guiando Buenas Decisiones after completion of the 6-month follow-up assessment. The study also includes a qualitative implementation evaluation with organizational stakeholders, project staff, interventionists, and participating parents to identify barriers and facilitators to Guiando Buenas Decisiones implementation that can inform future implementation strategies and to assess relevant implementation outcomes.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): September 20, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Individual participant data (IPD) and supporting information will be available following completion of the study and submission to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive (NDA), anticipated to begin by August 31, 2029. Data will remain available through the NDA for as long as they are maintained by the archive, in accordance with NDA data retention and access policies.
• Access Criteria: Qualified researchers may request access to de-identified individual participant data through the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive (NDA). Access will be provided in accordance with NDA data access, data use, and security requirements. Approved researchers will be able to access the study data and supporting information made available through the NDA for approved research purposes.

Locations

US (1)