Enlace Familiar: Supporting the Mental Health of Latino Adolescents

NCT07547631 — Not applicable, Not yet recruiting, 64 participants, University of Michigan

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Enlace Familiar Mental Health Intervention

Registry	NCT07547631
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, other
Enrollment	64 (Estimated)
Sponsor	University of Michigan (Other); collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Conditions	Mental Health
Interventions	Enlace Familiar (Behavioral)
Dates	start 2026-10-01 (estimated), primary completion 2028-04-01 (estimated), completion 2029-01-01 (estimated), first posted 2026-04-23, last updated 2026-08-17
Locations	1 site in United States

-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:

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Enlace Familiar	Experimental	Behavioral: Enlace Familiar	32 participants
Standard care	No intervention		32 participants

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.

+Outcome measures

Primary outcomes

Frequency of youth reported communication about mental health [Up to 6 months]: 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).

Secondary outcomes

Proportion of participants reporting moderate or greater satisfaction with the overall intervention [6 months]: 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.
Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention [6 months]: 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
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]

+Eligibility

Sex: All, ages: 14 Years to 18 Years

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.

+Locations (1)

Facility	City	Country	Status
University of Michigan	Ann Arbor, Michigan	United States

+Investigators

Fernanda Cross, Ph.D, Principal investigator, University of Michigan

+Funding

NIH grants: K01MD019325