The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Texas A&M University
- Enrollment
- 200
- Primary Endpoint
- Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Parenting Intervention (Behavioral)
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.
Outcomes
Primary Outcomes
Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention
Time Frame: 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.
Mean Acceptability of Intervention Measure Score Immediately Post-Intervention
Time Frame: 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.
Mean Intervention Appropriateness Measure Score Immediately Post-Intervention
Time Frame: 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.
Mean Feasibility of Intervention Measure Score Immediately Post-Intervention
Time Frame: 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.
Secondary Outcomes
- Change in Parent-Reported General Parenting Scale Mean Score From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Youth-Reported Depressive Symptoms From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Youth-Reported Anxiety Symptoms From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Youth-Reported Anxiety Symptoms From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Youth-Reported Externalizing Problems From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Youth-Reported Externalizing Problems From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Parent-Reported Youth Anxiety and Depression From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Parent-Reported Youth Anxiety and Depression From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Percentage of Participants Completing All Assigned LYFE-III Intervention Modules(From intervention initiation through completion of the approximately 3-week intervention)
- Percentage of Enrolled Families Completing the 3-Month Follow-Up Assessment(From enrollment through 3 months after intervention completion)
- Change in the Percentage of Youth Reporting Any Substance Use From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in the Percentage of Youth Reporting Any Substance Use From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Youth-Reported Likelihood of Future Substance Use From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Youth-Reported Likelihood of Future Substance Use From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
- Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to Immediately Post-Intervention(Baseline and immediately after completion of the approximately 3-week intervention)
- Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to 3-Month Follow-Up(Baseline and 3 months after intervention completion)
Investigators
Cory Cobb
Assistant Professor
Texas A&M University