Enlace Familiar: Supporting the Mental Health of Latino Adolescents

NCT07547631 | Not Yet Recruiting

• 2 other identifiers: HUM002829281K01MD019325-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to pilot and evaluate Enlace Familiar, a culturally responsive intervention designed to support Latino adolescents in discussing their mental health needs with caregivers or other trusted adults. The study will examine the feasibility and acceptability of the intervention and examine its potential impact on mental health communication among Latino adolescents ages 14-18 experiencing mental health concerns. Participants will be randomized into two groups, with 32 adolescents assigned to the Enlace Familiar intervention and 32 adolescents assigned to a control condition. The intervention will be implemented in partnership with community health workers (CHWs), who will serve as culturally relevant facilitators. The main questions this study aims to answer are:

• Complete baseline assessments related to mental health communication, attitudes toward mental health, mental health literacy, and engagement in mental health services.
• Participate in the Enlace Familiar intervention, delivered by trained CHWs.
• Complete follow-up assessments to evaluate changes in primary and secondary outcomes.
• Participate in qualitative interviews or feedback activities to provide information about the acceptability and perceived usefulness of the intervention. Researchers will use a mixed methods design to evaluate intervention feasibility and acceptability and to explore preliminary changes in adolescent mental health communication following participation in the intervention.

Conditions

Mental Health

Keywords

Adolescent

Outcome Measures

Primary Outcomes (1)

• Frequency of youth reported communication about mental health

  Measured 3 times on a Likert type scale effect of Enlace Familiar on youth (i.e., none, 1-3 times, 3-5 times, more than 5 times).

  Up to 6 months

Secondary Outcomes (4)

• Proportion of participants reporting moderate or greater satisfaction with the overall intervention

  6 months

• Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention

  6 months

• Retention as measured by the percent of enrolled participants who completed the 8-week follow up

  6 months

• Adherence as measured by the percent of participant who attended both CHW-led sessions

  6 months

Study Arms (2)

Enlace Familiar

EXPERIMENTAL

32 participants

Behavioral: Enlace Familiar

Standard care

NO INTERVENTION

32 participants

Interventions

Enlace Familiar BEHAVIORAL

Enlace Familiar will consist of two individual encounters, in person or virtual. Youth will also receive a list of mental health community resources, including school-based, online, and apps-based support.

Enlace Familiar

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• High school-age adolescents, ages 14-18 who self-identify as Latino
• Adolescents scoring between 3-12 on the Patient Health Questionnaire-4 (PHQ-4), a brief mental health screening tool for anxiety and depression
• Adolescents who are not currently receiving mental health treatment or in the past 12 months
• Adolescents fluent in Spanish or English
• Parents of High school-age adolescents, ages 14-18 who completed the intervention (T3)
• Parents fluent in Spanish or English
• ● CHW who implemented our intervention

You may not qualify if:

• youth not fluent in English or Spanish
• youth currently receiving mental health treatment or who have received it in the past year
• parents of High school-age adolescents, ages 14-18 who did not completed the intervention (T3);
• parents not fluent in Spanish or English
• ● CHWs not involved in our intervention.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Fernanda Cross, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda L. Cross, Ph.D

CONTACT

(734) 945-3606; flcross@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Social Work

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)