An interventional study of Guiando Buenas Decisiones (GBD) in Alcohol Use, Underage Drinking and Parenting Intervention, sponsored by University of Texas at Austin. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Prevention
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:
The study will first conduct a small pilot to refine Guiando Buenas Decisiones and optimize the intervention and study procedures based on feedback from participating families. The study will then conduct a randomized controlled trial comparing families who receive the refined Guiando Buenas Decisiones program with families assigned to a wait-list control group. Families in the wait-list control group will be offered Guiando Buenas Decisiones after completing the 6-month follow-up assessment.
The refined Guiando Buenas Decisiones program consists of seven weekly sessions, each lasting approximately 2 hours, delivered by trained community health workers and lay church members. In the randomized trial, parents and adolescents will complete separate assessments at baseline, immediately after the intervention, and 6 months after the intervention. These assessments will examine adolescent alcohol initiation and use and family, individual, and sociocultural risk and protective factors related to adolescent alcohol use. Information will also be collected from parents, program facilitators, and organizational stakeholders to identify individual- and organizational-level barriers and facilitators to implementation and to assess implementation outcomes in a faith-based community setting.
Guiando Buenas Decisiones is the Spanish-language adaptation of Guiding Good Choices, a family-based prevention program grounded in the Social Development Model. The intervention is delivered to parents and is based on the premise that strengthening family processes and parent-child bonding can promote positive youth development and help prevent adolescent alcohol use. Guiando Buenas Decisiones includes components addressing positive involvement with youth, recognition and reinforcement of positive behaviors, family problem solving, clear and consistent limits, monitoring and supervision, and alcohol-related knowledge and expectancies.
The study will be conducted in two phases. In Phase I, the Guiando Buenas Decisiones curriculum will be refined for implementation with Hispanic immigrant families through a faith-based organization in Central Texas. Guided by the Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, and Testing framework and previous adaptation research, refinements will address the cultural and contextual relevance of the intervention. These refinements will include an introductory session addressing immigration-related experiences and parenting needs, discrimination, biculturalism, and parent-youth cultural conflicts. The Framework for Reporting Adaptations and Modifications-Enhanced will be used to document refinements to the intervention.
Community health workers and lay church members will be trained to deliver Guiando Buenas Decisiones in group settings. Following training, two pilot parenting groups will be conducted using a single-condition pre- and post-intervention design. The pilot will be used to further optimize the cultural relevance and acceptability of the refined curriculum, intervention delivery, and study procedures. Feedback from participating parents will inform final refinements before the randomized controlled trial.
In Phase II, the refined Guiando Buenas Decisiones program will be evaluated in a randomized controlled trial comparing the intervention with a wait-list control condition. Parents will serve as the unit of randomization. Families assigned to the wait-list control condition will be offered Guiando Buenas Decisiones after completion of the 6-month follow-up assessment. The trial will evaluate changes in adolescent alcohol initiation and use and family, individual, and sociocultural risk and protective factors. Intervention delivery will include ongoing supervision and fidelity monitoring, and additional modifications to the intervention will be documented using the Framework for Reporting Adaptations and Modifications-Enhanced.
The study will also examine barriers and facilitators to implementing Guiando Buenas Decisiones through faith-based organizations. Guided by the Practical, Robust Implementation and Sustainability Model, qualitative data will be collected from organizational leaders and managers, project staff and interventionists, and participating parents. The evaluation will examine factors such as the fit of Guiando Buenas Decisiones within faith-based organizations, the external environment, implementation and sustainability infrastructure, participant experiences, intervention delivery, and logistical factors that may facilitate or impede participation and implementation.
Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach will address the extent to which the program engages the target population. Adoption will examine the training and retention of interventionists. Implementation will address feasibility, acceptability, participant engagement, and fidelity of intervention delivery. Maintenance will examine longer-term participant outcomes and the potential for Guiando Buenas Decisiones to become integrated into routine organizational practices within the faith-based setting.
Together, the efficacy and implementation findings from this exploratory study will inform the design of a future larger-scale effectiveness and implementation trial of Guiando Buenas Decisiones in community settings.
939 studies on the registry are indexed under Alcohol Drinking; 169 are open to participants now.
This study's planned enrollment of 440 is above the median of 108 across 813 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Texas at Austin is the lead sponsor of 326 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Parents:
Children:
Organizational Leaders, Managers, and Interventionists:
Business or Strategic Funding Leaders:
Exclusion Criteria:
Parents:
Children:
Organizational Leaders, Managers, and Interventionists:
Business or Strategic Funding Leaders:
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)
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Family risk and protective factors
Both caregivers and their children will complete items measured using an adapted version of the original Guiding Good Choices program implementation-evaluation surveys, which were based on the Communities That Care Youth Survey and its adaptation for Mexico and Colombia. The assessment will measure three protective factors (i.e., clear standards for youth behavior, proactive family communication, and positive family involvement) and three risk factors (i.e., positive attitudes for substance use, poor family management, and family conflict).
Time frame: Baseline, post-intervention (7 weeks), 6 months post-intervention
Perceived discrimination
Both caregivers and their children will complete the 7-item Perceived Discrimination Scale to assess perceived experiences of discrimination.
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Perceived negative context of reception
Both caregivers and their children will complete the 6-item Negative Context of Reception Scale to assess perceived negative context of reception.
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Language stress
Both caregivers and their children will complete the language stress subscale of the Hispanic Stress Inventory to assess stress associated with language use and communication.
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Implementation outcome - Reach
Reach will be assessed as (a) the number of parents who meet eligibility criteria as a proportion of all parents contacted by the faith-based organization and (b) the number of parents who meet eligibility criteria and attend at least one GBD session as a proportion of all contacted parents. Data will be obtained from study records kept by recruiters and GBD enrollment and attendance records kept by interventionists.
Time frame: Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start
Implementation outcome - Adoption
Adoption will be assessed by calculating the number and proportion of interventionists (e.g., community health workers) trained and retained to administer the program throughout the study period. Data will be obtained from study records.
Time frame: Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start
Implementation outcome - Acceptability: Parent attendance
Parent attendance will be tracked using a dedicated attendance list for each intervention session.
Time frame: Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start
Implementation outcome - Acceptability: Parent engagement
Parent engagement will be self-reported by caregivers at the end of each session using a validated 10-item measure developed by the research team. The measure assesses five dimensions of engagement: involvement, interest in materials, openness, positive affect toward interventionists, and positive affect toward other parents/group members.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Acceptability: Parent satisfaction
Parent satisfaction will be assessed using the Guiando Buenas Decisiones Session Evaluation Surveys administered at the conclusion of each session. Qualitative data on parent satisfaction with the intervention will also be collected using a focus group interview guide.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Feasibility: Parent knowledge
After each session, parents will report their knowledge related to the session-specific content using Guiando Buenas Decisiones post-session evaluation surveys developed by the program developers.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Feasibility: Parent attitudes
After each session, parents will report their attitudes related to the session-specific content using Guiando Buenas Decisiones post-session evaluation surveys developed by the program developers.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Feasibility: Parent skills
After each session, parents will report their skills related to the session-specific content using Guiando Buenas Decisiones post-session evaluation surveys developed by the program developers.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Feasibility: Parent behaviors
After each session, parents will report their behaviors related to the session-specific content using Guiando Buenas Decisiones post-session evaluation surveys developed by the program developers.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Fidelity
Fidelity will be measured using the 7-item Guiando Buenas Decisiones fidelity survey to assess dosage, adherence, and quality of intervention delivery.
Time frame: At the end of each weekly intervention session, over the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start.
Implementation outcome - Maintenance
Maintenance will be assessed through longer-term outcomes, including family risk and protective factors and youth alcohol use, using the measures specified for these outcomes. The study will also assess the program's potential to become integrated into routine organizational practices within the faith-based organization by examining organizational-level barriers and facilitators using an interview guide designed for this study.
Time frame: Baseline and 6 months post-intervention
Plan to share: Yes — De-identified individual participant data collected as part of this study will be shared through the National Institute on Alcohol Abuse and Alcoholism Data Archive (NDA) in accordance with National Institutes of Health (NIH) and National Institute on Alcohol Abuse and Alcoholism data sharing requirements. Shared data will include participant-level data associated with study assessments and outcomes, with personally identifiable information removed or protected in accordance with applicable requirements. Data sharing will follow the study's NIH-approved Data Management and Sharing Plan and applicable NDA policies and procedures.
Supporting information: Study protocol, Informed consent form
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.
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Sep 2028, 21 months later.
Of 429 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 21 months is below that.
Counting every sponsor, half of 443 studies reached it within 26 months; a quarter within 11 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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