[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659728":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":83,"studyPopulation":75,"armGroups":84,"interventions":95,"overallOfficials":101,"centralContacts":106,"locations":111,"responsibleParty":132,"collaborators":134,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":75,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":75,"enrollmentInfo":154,"targetDuration":75,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":168,"overallStatus":177,"whyStopped":75,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":75},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"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\u002Fno) at each assessment.","Baseline, post-intervention (7 weeks), and 6 months post-intervention",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":12},"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.",{"measure":23,"description":24,"timeFrame":12},"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.",[26,30,33,36,39,43,46,49,53,56,59,62,65,68,71],{"measure":27,"description":28,"timeFrame":29},"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).","Baseline, post-intervention (7 weeks), 6 months post-intervention",{"measure":31,"description":32,"timeFrame":12},"Perceived discrimination","Both caregivers and their children will complete the 7-item Perceived Discrimination Scale to assess perceived experiences of discrimination.",{"measure":34,"description":35,"timeFrame":12},"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.",{"measure":37,"description":38,"timeFrame":12},"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.",{"measure":40,"description":41,"timeFrame":42},"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.","Through completion of the randomized controlled trial intervention delivery period, an average of 10 months after Aim 2 start",{"measure":44,"description":45,"timeFrame":42},"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.",{"measure":47,"description":48,"timeFrame":42},"Implementation outcome - Acceptability: Parent attendance","Parent attendance will be tracked using a dedicated attendance list for each intervention session.",{"measure":50,"description":51,"timeFrame":52},"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\u002Fgroup members.","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.",{"measure":54,"description":55,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":52},"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.",{"measure":60,"description":61,"timeFrame":52},"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.",{"measure":63,"description":64,"timeFrame":52},"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.",{"measure":66,"description":67,"timeFrame":52},"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.",{"measure":69,"description":70,"timeFrame":52},"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.",{"measure":72,"description":73,"timeFrame":74},"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.","Baseline and 6 months post-intervention",null,{"allocation":77,"interventionModel":78,"interventionModelDescription":79,"primaryPurpose":80,"observationalModel":75,"timePerspective":75,"maskingInfo":81},"RANDOMIZED","PARALLEL","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.","PREVENTION",{"masking":82,"maskingDescription":75,"whoMasked":75},"NONE","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.\n\nThe 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.\n\nCommunity 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.\n\nIn 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.\n\nThe 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.\n\nImplementation 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.\n\nTogether, 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.",[85,91],{"label":86,"type":87,"description":88,"interventionNames":89},"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.",[90],"Behavioral: Guiando Buenas Decisiones (GBD)",{"label":92,"type":93,"description":94,"interventionNames":75},"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.",[96],{"type":97,"name":98,"description":99,"armGroupLabels":100,"otherNames":75},"BEHAVIORAL","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.",[86],[102],{"name":103,"affiliation":104,"role":105},"Pablo Montero-Zamora","The University of Texas at Austin","PRINCIPAL_INVESTIGATOR",[107],{"name":103,"role":108,"phone":109,"phoneExt":75,"email":110},"CONTACT","512-232-5846","pmontero@austin.utexas.edu",[112],{"facility":113,"status":75,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"El Buen Samaritano","Austin","Texas","78744","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-97.74306,30.26715,{"lat":123,"lon":122},[126,130],{"name":127,"role":108,"phone":128,"phoneExt":75,"email":129},"Rosamaria Murillo, PhD, LMSW","512-439-8900","rmurillo@elbuen.org",{"name":127,"role":131,"phone":75,"phoneExt":75,"email":75},"SUB_INVESTIGATOR",{"type":105,"investigatorFullName":103,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":75,"oldOrganization":75},"Assistant Professor",[135,138,141,143],{"name":136,"class":137},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH",{"name":139,"class":140},"University of Washington, Social Development Research Group","UNKNOWN",{"name":142,"class":140},"University of Miami, Miami, United States",{"name":113,"class":140},"100659728","parent-focused-alcohol-prevention-program-for-hispanic-families-in-faith-based-settings-100659728",false,"NCT07869550","Parent-Focused Alcohol Prevention Program for Hispanic Families in Faith-Based Settings","Implementing and Testing a Parent-Focused Alcohol Prevention Program for Hispanics in Faith-Based Settings","Inclusion Criteria:\n\nParents:\n\n* Being 18 years or older.\n* Living in a one- or two-parent household.\n* Self-identifying as Hispanic or Latino\u002Fa.\n* Self-identifying as a foreign-born and first-generation Hispanic immigrant with one or more United States-born 12-14-year-old children.\n* Spanish speaker.\n* Provide written consent to participate in a parenting intervention trial and to be videotaped during parenting sessions.\n* 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.\n\nChildren:\n\n* Being United States-born or foreign-born.\n* Aged 12-14 years.\n* Self-identifying as Hispanic or Latino\u002Fa.\n* Being English- or Spanish-speaking, or bilingual.\n\nOrganizational Leaders, Managers, and Interventionists:\n\n* Be affiliated with a faith-based or Hispanic-serving organization in Travis County.\n* Express a commitment to participate in the investigation.\n* Interventionists should express a commitment to being trained in the Guiando Buenas Decisiones intervention.\n* Provide written consent to participate in the evaluation component of this study.\n\nBusiness or Strategic Funding Leaders:\n\n* Express an interest to support the sustainment goals of this program of research.\n* Provide written consent to participate in the evaluation component of this study.\n\nExclusion Criteria:\n\nParents:\n\n* Involvement with Child Protective Services (CPS) due to confirmed child abuse (e.g., physical or sexual abuse).\n* Current diagnosis of a severe psychiatric disorder that hinders participation in a parenting program (e.g., schizophrenia).\n\nChildren:\n\n* Current CPS-documented abuse by the caregiver seeking to participate in the parenting program.\n* 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.\n\nOrganizational Leaders, Managers, and Interventionists:\n\n* Lack experience working with Hispanic populations.\n* Not expressing an interest to participate in this investigation in any of the aforementioned roles (i.e., organization leader, manager, interventionist).\n* Refuse to provide written consent to participate in this investigation.\n\nBusiness or Strategic Funding Leaders:\n\n* Not expressing an interest to participate in this study.\n* Refuse to provide written consent to participate in this investigation.",true,"ALL","12 Years",{"count":155,"type":156},440,"ESTIMATED","INTERVENTIONAL",[159],"NA","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.\n\nThe main questions this study aims to answer are:\n\n1. Does the refined Guiando Buenas Decisiones program help prevent or delay alcohol initiation and use among adolescents?\n2. 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?\n3. What individual- and organizational-level barriers and facilitators affect implementation of the refined Guiando Buenas Decisiones program?\n4. What are the reach, adoption, implementation, and maintenance outcomes of delivering the refined Guiando Buenas Decisiones program through a faith-based community organization?\n\nThe 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.\n\nThe 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.",[162,163,164,165,166,167],"Alcohol Use","Underage Drinking","Parenting Intervention","Prevention","Faith-Based","Implementation Science",[169,163,164,170,171,172,167,173,174,175,176],"Alcohol Prevention","Guiando Buenas Decisiones","Family-Based Prevention","Faith-Based Organizations","Prevention Science","Community Health Workers","Risk and Protective Factors","Hispanic Families","NOT_YET_RECRUITING","2026-10-06",{"date":180,"type":181},"2026-10-09","ACTUAL",{"date":183,"type":156},"2026-12-15",{"date":185,"type":156},"2029-08-31",{"name":5,"class":6},1]