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NCT Number: NCT07547631

Enlace Familiar: Supporting the Mental Health of Latino Adolescents

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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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Frequency of youth reported communication about mental health

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Fernanda L. Cross, Ph.D

CONTACT

[email protected]

(734) 945-3606

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Enlace Familiar Mental Health Intervention

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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