Alcohol UseNCT07869550
Parent-Focused Alcohol Prevention Program for Hispanic Families in Faith-Based Settings
A study testing Guiando Buenas Decisiones (GBD) in people with Alcohol Use and Underage Drinking, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Underage Drinking, Parenting Intervention
- What is being tested?
- Guiando Buenas Decisiones (GBD)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
- Express a commitment to participate in the investigation.
- Interventionists should express a commitment to being trained in the Guiando Buenas Decisiones intervention.
- Provide written consent to participate in the evaluation component of this study.
- Business or Strategic Funding Leaders:
- Express an interest to support the sustainment goals of this program of research.
- Provide written consent to participate in the evaluation component of this study.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
El Buen Samaritano
Austin, Texas, 78744
Rosamaria Murillo, PhD, LMSW, 512-439-8900, rmurillo@elbuen.org
Rosamaria Murillo, PhD, LMSW
About this study
Official title: Implementing and Testing a Parent-Focused Alcohol Prevention Program for Hispanics in Faith-Based Settings
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:
Read more
- Does the refined Guiando Buenas Decisiones program help prevent or delay alcohol initiation and use among adolescents?
- 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?
- What individual- and organizational-level barriers and facilitators affect implementation of the refined Guiando Buenas Decisiones program?
- What are the reach, adoption, implementation, and maintenance outcomes of delivering the refined Guiando Buenas Decisiones program through a faith-based community organization?
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.
Read the detailed description
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.
- Conditions
- Alcohol Use, Underage Drinking, Parenting Intervention, Prevention, Faith-Based, Implementation Science
- Being tested
- Guiando Buenas Decisiones (GBD)
- 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
- Medical subject headings
- Alcohol Drinking, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guiando Buenas Decisiones (GBD)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Secondary outcomes (15)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion20 Sep 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, Social Development Research Group, University of Miami, Miami, United States, El Buen Samaritano
- Responsible party
- Principal investigator, Pablo Montero-Zamora, University of Texas at Austin
- Investigators
- Pablo Montero-Zamora, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869550
- Sponsor's protocol ID
- STUDY00009687
- Other IDs
- R34AA032397
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing and Testing a Parent-Focused Alcohol Prevention Program for Hispanics in Faith-Based Settings
- ClinicalTrials.gov ID
- NCT07869550
- Acronym / sponsor ID
- STUDY00009687
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Washington, Social Development Research Group, University of Miami, Miami, United States, El Buen Samaritano
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 20 Sep 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the refined Guiando Buenas Decisiones program help prevent or delay alcohol initiation and use among adolescents?
- 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?
- What individual- and organizational-level barriers and facilitators affect implementation of the refined Guiando Buenas Decisiones program?
- What are the reach, adoption, implementation, and maintenance outcomes of delivering the refined Guiando Buenas Decisiones program through a faith-based community organization?
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Guiando Buenas Decisiones Intervention | Experimental | Behavioral: Guiando Buenas Decisiones (GBD)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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
- 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.
- Lack experience working with Hispanic populations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guiando Buenas Decisiones (GBD)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. | Behavioural | Guiando Buenas Decisiones Intervention |
Primary outcome
Adolescent alcohol use initiation
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
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.
Adolescent past-year alcohol use frequency
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
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.
Adolescent past-year alcohol use quantity
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
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.
Adolescent past-30-day alcohol use frequency
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
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.
Adolescent past-30-day alcohol use quantity
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
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.
15 secondary outcomes
Family risk and protective factors
Time frame: Baseline, post-intervention (7 weeks), 6 months post-intervention
Perceived discrimination
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Perceived negative context of reception
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Language stress
Time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention
Implementation outcome - Reach
Time frame: Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start
Implementation outcome - Adoption
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
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
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
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
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
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
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
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
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
Time frame: Baseline and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Alcohol Use
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pablo Montero-Zamora principal investigator
The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guiando Buenas Decisiones (GBD) in people with Alcohol Use and Underage Drinking, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pablo Montero-Zamora (512-232-5846, pmontero@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent alcohol use initiation (time frame: Baseline, post-intervention (7 weeks), and 6 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.