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Not yet recruitingNCT07547631Updated Aug 17, 2026

Enlace Familiar: Supporting the Mental Health of Latino Adolescents

An interventional study of Enlace Familiar in Mental Health, sponsored by University of Michigan. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by University of Michigan · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Mental Health

Keywords

  • Adolescent
03

In context

Psychological Well-Being

971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

This study's planned enrollment of 64 is below the median of 116 across 830 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Enlace Familiar

    32 participants

    Behavioral: Enlace Familiar

  • No intervention
    Standard care

    32 participants

Interventions

  • BehavioralEnlace 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.

06

What researchers measure

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).

    Time frame: Up to 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

07

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
08

References and documents

Individual participant data

Plan to share: No — There are no plans to share the information publicly, but data may be shared with researchers upon request to the principal investigator.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07547631
Lead sponsor
University of Michigan
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
Responsible party
Fernanda Cross (Assistant Professor of Social Work, University of Michigan) — Principal investigator
First posted
Apr 23, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Aug 17, 2026

Study contacts

Fernanda L. Cross, Ph.D
Contact
flcross@umich.edu
(734) 945-3606
Fernanda Cross, Ph.D
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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