Enlace Familiar: Supporting the Mental Health of Latino Adolescents

Enlace Familiar Mental Health Intervention

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:

1. Is Enlace Familiar feasible and acceptable for Latino adolescents when delivered by CHWs?
2. Does participation in Enlace Familiar improve adolescents' discussions of mental health needs with caregivers or other trusted adults?

Participants will:

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Enlace Familiar

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernanda L. Cross, Ph.D; Phone Number: (734) 945-3606; Email: flcross@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Our inclusion criteria for youth participation include:

• 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

Our inclusion criteria for parent participation include:

• Parents of High school-age adolescents, ages 14-18 who completed the intervention (T3)
• Parents fluent in Spanish or English

Our inclusion criteria for Community Health Worker participation include:

● CHW who implemented our intervention

Our Exclusion Criteria: for youth participation include:

• youth not fluent in English or Spanish
• youth currently receiving mental health treatment or who have received it in the past year

Our exclusion criteria for parent include:

• parents of High school-age adolescents, ages 14-18 who did not completed the intervention (T3);
• parents not fluent in Spanish or English

Our exclusion criteria for Community Health Worker participation include

● CHWs not involved in our intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enlace Familiar; 32 participants	Behavioral: Enlace Familiar; 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.
No Intervention: Standard care; 32 participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants reporting moderate or greater satisfaction with the overall intervention	moderate or greater satisfaction is ≥ 80% threshold on 4 questions of 5-point Likert scales using the Acceptability of Intervention Measure (AIM). Higher scores indicate increased acceptability.	6 months
Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention	moderate or greater satisfaction is ≥80% threshold) using a brief, study-specific satisfaction scale developed for this project rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The measure includes 6-8 items evaluating participants' perceptions of the community health worker's communication, support, respect, and overall helpfulness	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Fernanda Cross, Ph.D, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: HUM00282928; 1K01MD019325-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share the information publicly, but data may be shared with researchers upon request to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No