The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families

NCT07761052 | Not Yet Recruiting

• 2 other identifiers: STUDY2025-11345R34MH134935
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Control Condition; Parent

Outcome Measures

Primary Outcomes (4)

• Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-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

• Mean Acceptability of Intervention Measure Score Immediately Post-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.

  Immediately after completion of the approximately 3-week intervention

• Mean Intervention Appropriateness Measure Score Immediately Post-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.

  Immediately after completion of the approximately 3-week intervention

• Mean Feasibility of Intervention Measure Score Immediately Post-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.

  Immediately after completion of the approximately 3-week intervention

Secondary Outcomes (20)

• 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

Study Arms (2)

Parenting

EXPERIMENTAL

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.

Behavioral: Parenting Intervention

Control

NO INTERVENTION

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.

Interventions

Parenting Intervention BEHAVIORAL

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.

Parenting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead
• National Institute of Mental Health (NIMH): collaborator

Central Study Contacts

Cory L Cobb, PhD

CONTACT

501-749-3382; cory.cobb@tamu.edu

Lawrence Watkins, MS

CONTACT

832-364-2600; lgwatkins@tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE