The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families ((LYFE-III))
11 de agosto de 2026 atualizado por: Cory Cobb, Texas A&M University
The objective of this study is to harness digital technology to bring to scale a culturally adapted and evidence-based parenting intervention for Latinos (Nuestras Familias: Andando Entre Culturas). The Latino Youth and Family Empowerment - III study (LYFE-III) proposed here will adapt, scale, and evaluate the efficacy of an online version of Nuestras Familias with Latino parents and youth in a randomized controlled trial (RCT). The specific aims are as follows:
Aim 1. To adapt the Nuestras Familias intervention to an online format that can be widely accessed by underserved Latino families. This process includes intervention refinement, enhancing efficiency, and manualization of intervention content
Aim 2. Conduct a small randomized controlled pilot trial to (a) test the online program's promise while evaluating changes in target mechanisms of action (i.e., parenting practices) and their subsequent effects on youth mental health outcomes; and (b) to evaluate the feasibility, appropriateness, and acceptability of the online version of the Nuestras Familias intervention.
Visão geral do estudo
Status
Status
Ainda não está recrutando
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
The Latino Youth and Family Empowerment Study-III (LYFE-III) is designed to adapt and pilot test Nuestras Familias: Andando Entre Culturas, a culturally adapted, evidence-based parenting intervention for Latino families. Nuestras Familias integrates principles from parent management training, social learning theory, and ecodevelopmental theory. The program is intended to strengthen parenting practices that may protect against mental and behavioral health problems among Latino youth.
The study consists of two stages. During the first stage, the existing intervention will be adapted from a group-based, in-person format to a self-guided online format. The digital program will preserve the intervention's core parenting components while making the content more accessible and reducing the time and logistical demands associated with attending in-person sessions. Latino parents and community stakeholders will participate in an iterative user-centered refinement process to evaluate the program's cultural relevance, usability, clarity, and technological accessibility. Feedback from successive focus groups will be used to revise and finalize the digital intervention and its accompanying online manual.
The digital intervention will address parental involvement, monitoring, positive reinforcement and skill encouragement, appropriate and consistent discipline, family communication, and family problem solving. It will also address experiences relevant to Latino families, including familismo, respeto, parent-youth differences in acculturation, family and gender roles, language barriers, discrimination, and structural barriers affecting families. Program content will include brief presentations, demonstrations and video-based role plays, interactive activities, summaries of key concepts, and opportunities for parents to practice parenting strategies at home. Parents will proceed through the program sequentially and will receive access to new content on a weekly basis. An online discussion forum, periodic program-related messages, progress tracking, and contact with the research team will be used to support engagement.
During the second stage, the refined intervention will be evaluated in a randomized pilot trial. Participating families will be randomly assigned to receive either the LYFE-III online parenting intervention or services as usual through the collaborating community organization. Families assigned to services as usual will retain access to the organization's customary resources but will not receive LYFE-III during the trial. They will be offered access to the intervention after completion of study activities.
Parents and youth will complete online assessments before the intervention, at the end of the approximately four-month intervention period, and three months after the intervention ends. The pilot is intended to evaluate the feasibility, acceptability, appropriateness, engagement, and initial promise of delivering the culturally adapted intervention online. It will also estimate intervention-related changes in parenting practices and youth mental and behavioral health and examine whether changes in parenting practices are associated with subsequent changes in youth outcomes. Findings will be used to refine the intervention and its implementation procedures and to inform a future, larger-scale effectiveness trial.
Tipo de estudo
Tipo de estudo
Intervencional
Inscrição (Estimado)
Inscrição
200
Estágio
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
Contato de estudo
- Nome: Cory L Cobb, PhD
- Número de telefone: 501-749-3382
- E-mail: cory.cobb@tamu.edu
Estude backup de contato
- Nome: Lawrence Watkins, MS
- Número de telefone: 832-364-2600
- E-mail: lgwatkins@tamu.edu
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria
- The family identifies as Latino or Hispanic.
- The family includes a child in the sixth or seventh grade.
- The child is newly enrolled in or has recently begun receiving services through Breakthrough Central Texas.
- At least one parent or primary caregiver speaks Spanish.
- A parent or primary caregiver and the participating child are willing to complete study assessments.
- The parent or primary caregiver agrees that the family may be randomly assigned to either the LYFE-III intervention group or the services-as-usual group.
- The parent or primary caregiver is willing to complete the online parenting program if assigned to the LYFE-III intervention group.
- The parent or legal guardian is willing to provide informed consent, and the child is willing to provide assent.
Exclusion Criteria
- The parent or primary caregiver is currently participating in another parenting education or parent-training program.
- A participating parent or child has an active, severe mental health condition, such as schizophrenia or another psychotic disorder, that would make participation in a preventive parenting program inappropriate.
- A participating parent or child has mental health or substance-use needs that, after review by a study psychologist, require a higher level of care than the LYFE-III prevention program provides.
- The parent or child is unable or unwilling to complete the study procedures or participate in the assigned study condition.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Número de braços
2
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
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Experimental: Parenting
Families assigned to this arm will receive the LYFE-III digital version of Nuestras Familias: Andando Entre Culturas.
Parents will complete sequential, self-guided online modules addressing parental involvement, monitoring, positive reinforcement and skill encouragement, consistent discipline, family communication, problem solving, and culturally relevant experiences affecting Latino families.
The program includes presentations, video demonstrations, interactive activities, home-practice exercises, weekly messages, progress tracking, and an online discussion forum.
Families may also receive services ordinarily available through the collaborating community organization.
|
LYFE-III is a culturally adapted, self-guided online parenting intervention delivered to parents of Latino youth over approximately four months.
Parents receive sequential access to one digital module per week.
Modules address parental involvement, monitoring, positive reinforcement and skill encouragement, consistent discipline, family communication, problem solving, and culturally relevant experiences such as familismo, respeto, parent-youth differences in acculturation, discrimination, and structural barriers.
Modules include brief presentations, video demonstrations and role plays, interactive activities, summaries, and home-practice exercises.
Engagement supports include weekly program-related messages, progress tracking, periodic contact from the research team, and an online discussion forum where parents can discuss their practice experiences and receive feedback.
|
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Sem intervenção: Control
Families assigned to this arm will not receive the LYFE-III intervention during the trial.
They may continue to access services ordinarily available through the collaborating community organization.
Use of these services will be monitored during the study.
Families in this arm will be offered access to the LYFE-III online parenting intervention after completing study activities.
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O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
The 9-item General Parenting Scale assesses parents' perceived ability to use effective parenting practices, including communication, problem solving, encouragement, limit setting, monitoring, positive involvement, consistent discipline, and implementation of consequences.
Each item is scored from 1 to 5. The mean score ranges from 1 to 5, with higher scores indicating more effective parenting practices.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Mean Acceptability of Intervention Measure Score Immediately Post-Intervention
Prazo: Immediately after completion of the approximately 3-week intervention
|
The 4-item Acceptability of Intervention Measure assesses the extent to which participants perceive LYFE-III as agreeable, appealing, and satisfactory.
Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged.
Mean scores range from 1 to 5, with higher scores indicating greater intervention acceptability.
This outcome is assessed among participants assigned to the LYFE-III intervention.
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Immediately after completion of the approximately 3-week intervention
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Mean Intervention Appropriateness Measure Score Immediately Post-Intervention
Prazo: Immediately after completion of the approximately 3-week intervention
|
The 4-item Intervention Appropriateness Measure assesses the perceived fit, relevance, suitability, and applicability of LYFE-III.
Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged.
Mean scores range from 1 to 5, with higher scores indicating greater perceived appropriateness.
This outcome is assessed among participants assigned to the LYFE-III intervention.
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Immediately after completion of the approximately 3-week intervention
|
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Mean Feasibility of Intervention Measure Score Immediately Post-Intervention
Prazo: Immediately after completion of the approximately 3-week intervention
|
The 4-item Feasibility of Intervention Measure assesses the extent to which participants perceive LYFE-III as implementable, possible, doable, and easy to use.
Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged.
Mean scores range from 1 to 5, with higher scores indicating greater perceived feasibility.
This outcome is assessed among participants assigned to the LYFE-III intervention.
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Immediately after completion of the approximately 3-week intervention
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Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Parent-Reported General Parenting Scale Mean Score From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
The 9-item General Parenting Scale assesses parents' perceived ability to use effective parenting practices, including communication, problem solving, encouragement, limit setting, monitoring, positive involvement, consistent discipline, and implementation of consequences.
Each item is scored from 1 to 5. The mean score ranges from 1 to 5, with higher scores indicating more effective parenting practices.
|
Baseline and 3 months after intervention completion
|
|
Change in Youth-Reported Depressive Symptoms From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Youth depressive symptoms are assessed with the 9-item Patient Health Questionnaire Modified for Teens.
Each item is scored from 0 (not at all) to 3 (nearly every day) and summed.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
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Baseline and immediately after completion of the approximately 3-week intervention
|
|
Change in Youth-Reported Anxiety Symptoms From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Youth anxiety symptoms are assessed with the 7-item Generalized Anxiety Disorder scale.
Each item is scored from 0 (not at all) to 3 (nearly every day) and summed.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Youth-Reported Anxiety Symptoms From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Youth anxiety symptoms are assessed with the 7-item Generalized Anxiety Disorder scale.
Each item is scored from 0 (not at all) to 3 (nearly every day) and summed.
Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
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Baseline and 3 months after intervention completion
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Change in Youth-Reported Externalizing Problems From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Externalizing problems are assessed with the 10-item Youth Externalizing Problems Screener.
Items assess behaviors such as anger, arguing, rule breaking, aggression, impulsivity, inattention, and failure to follow directions.
Each item is scored from 1 (almost never) to 4 (almost always) and summed.
Total scores range from 10 to 40, with higher scores indicating more frequent externalizing problems.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Youth-Reported Externalizing Problems From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Externalizing problems are assessed with the 10-item Youth Externalizing Problems Screener.
Items assess behaviors such as anger, arguing, rule breaking, aggression, impulsivity, inattention, and failure to follow directions.
Each item is scored from 1 (almost never) to 4 (almost always) and summed.
Total scores range from 10 to 40, with higher scores indicating more frequent externalizing problems.
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Baseline and 3 months after intervention completion
|
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Change in Parent-Reported Youth Anxiety and Depression From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Parent-reported youth anxiety and depressive symptoms are assessed with the 25-item Revised Child Anxiety and Depression Scale-Parent Version.
Each item is scored from 0 (never) to 3 (always).
The total raw score ranges from 0 to 75, with higher scores indicating greater combined anxiety and depressive symptom severity.
Anxiety and depression subscale scores may also be calculated.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Parent-Reported Youth Anxiety and Depression From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Parent-reported youth anxiety and depressive symptoms are assessed with the 25-item Revised Child Anxiety and Depression Scale-Parent Version.
Each item is scored from 0 (never) to 3 (always).
The total raw score ranges from 0 to 75, with higher scores indicating greater combined anxiety and depressive symptom severity.
Anxiety and depression subscale scores may also be calculated.
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Baseline and 3 months after intervention completion
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Percentage of Participants Completing All Assigned LYFE-III Intervention Modules
Prazo: From intervention initiation through completion of the approximately 3-week intervention
|
Intervention completion is defined as completing all required LYFE-III online modules.
The outcome is calculated as the number of participants assigned to LYFE-III who complete all required modules divided by the total number assigned to LYFE-III, multiplied by 100.
Percentages range from 0% to 100%, with higher percentages indicating greater intervention completion.
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From intervention initiation through completion of the approximately 3-week intervention
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Percentage of Enrolled Families Completing the 3-Month Follow-Up Assessment
Prazo: From enrollment through 3 months after intervention completion
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Retention is calculated as the number of enrolled families who complete the 3-month post-intervention assessment divided by the total number of enrolled families, multiplied by 100.
Percentages range from 0% to 100%, with higher percentages indicating greater study retention.
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From enrollment through 3 months after intervention completion
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Change in the Percentage of Youth Reporting Any Substance Use From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Youth substance use is assessed with the Oregon Social Learning Center Youth Substance Use Questionnaire.
Any substance use is defined as self-reported use of one or more assessed substances, including alcohol, tobacco, marijuana, or another drug, during the questionnaire's specified recall period.
The outcome is the percentage of youth meeting this criterion.
Percentages range from 0% to 100%, with higher percentages indicating more substance use.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in the Percentage of Youth Reporting Any Substance Use From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Youth substance use is assessed with the Oregon Social Learning Center Youth Substance Use Questionnaire.
Any substance use is defined as self-reported use of one or more assessed substances, including alcohol, tobacco, marijuana, or another drug, during the questionnaire's specified recall period.
The outcome is the percentage of youth meeting this criterion.
Percentages range from 0% to 100%, with higher percentages indicating more substance use.
|
Baseline and 3 months after intervention completion
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Change in Youth-Reported Likelihood of Future Substance Use From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' perceived likelihood of using alcohol, tobacco, marijuana, or other drugs in the future.
Item responses will be averaged to calculate a mean likelihood-of-use score.
Higher scores indicate a greater perceived likelihood of future substance use.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in Youth-Reported Likelihood of Future Substance Use From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' perceived likelihood of using alcohol, tobacco, marijuana, or other drugs in the future.
Item responses will be averaged to calculate a mean likelihood-of-use score.
Higher scores indicate a greater perceived likelihood of future substance use.
|
Baseline and 3 months after intervention completion
|
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Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' intentions to refuse opportunities to use alcohol, tobacco, marijuana, or other drugs.
Item responses will be averaged to calculate a mean refusal-intention score.
Higher scores indicate stronger intentions to refuse substance use.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' intentions to refuse opportunities to use alcohol, tobacco, marijuana, or other drugs.
Item responses will be averaged to calculate a mean refusal-intention score.
Higher scores indicate stronger intentions to refuse substance use.
|
Baseline and 3 months after intervention completion
|
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Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Substance-related risk is assessed using the parent-report version of the CRAFFT Screening Interview.
The six CRAFFT items assess riding in a vehicle with an impaired driver, using substances to relax or fit in, using substances alone, forgetting events while using substances, concerns expressed by family or friends, and substance-related trouble.
Each "yes" response receives 1 point.
Total scores range from 0 to 6, with higher scores indicating greater substance-related risk.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Substance-related risk is assessed using the parent-report version of the CRAFFT Screening Interview.
The six CRAFFT items assess riding in a vehicle with an impaired driver, using substances to relax or fit in, using substances alone, forgetting events while using substances, concerns expressed by family or friends, and substance-related trouble.
Each "yes" response receives 1 point.
Total scores range from 0 to 6, with higher scores indicating greater substance-related risk.
|
Baseline and 3 months after intervention completion
|
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Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to Immediately Post-Intervention
Prazo: Baseline and immediately after completion of the approximately 3-week intervention
|
Current tobacco use is assessed using the Consumer Self-Report Tobacco Assessment.
Current use is defined as reported current use of at least one assessed tobacco product, including cigarettes, electronic cigarettes or vaping products, pipes, cigars, or chewing tobacco.
The outcome is the percentage of youth meeting this criterion.
Percentages range from 0% to 100%, with higher percentages indicating more current tobacco use.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to 3-Month Follow-Up
Prazo: Baseline and 3 months after intervention completion
|
Current tobacco use is assessed using the Consumer Self-Report Tobacco Assessment.
Current use is defined as reported current use of at least one assessed tobacco product, including cigarettes, electronic cigarettes or vaping products, pipes, cigars, or chewing tobacco.
The outcome is the percentage of youth meeting this criterion.
Percentages range from 0% to 100%, with higher percentages indicating more current tobacco use.
|
Baseline and 3 months after intervention completion
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
Início do estudo
1 de setembro de 2026
Conclusão Primária (Estimado)
Conclusão Primária
31 de julho de 2027
Conclusão do estudo (Estimado)
Conclusão do estudo
31 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
7 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de agosto de 2026
Primeira postagem (Real)
Primeira postagem
12 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de agosto de 2026
Última verificação
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
Outros números de identificação do estudo
- STUDY2025-1134
- 5R34MH134935 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
This NIMH-funded study will generate individual-participant research data, and NIH expects investigators to share scientific data according to their approved plan.
"Yes" does not mean posting identifiable or unrestricted data publicly.
You can share deidentified data through a controlled-access repository or approved request process, with safeguards for minors and sensitive information such as immigration status.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- ANALYTIC_CODE
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .