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Not yet recruiting NCT07547631

Enlace Familiar: Supporting the Mental Health of Latino Adolescents

No phase Interventional Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enlace Familiar.
Who it may be relevant to
Registry conditions: Mental Health. Basic parameters: 14 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Enlace Familiar Mental Health Intervention

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Frequency of youth reported communication about mental health [Time frame: Up to 6 months]
Secondary outcome measures (4)
  • Proportion of participants reporting moderate or greater satisfaction with the overall intervention [Time frame: 6 months]
  • Proportion of participants reporting moderate or greater satisfaction with Community Health Workers (CHWs) delivering the intervention [Time frame: 6 months]
  • Retention as measured by the percent of enrolled participants who completed the 8-week follow up [Time frame: 6 months]
  • Adherence as measured by the percent of participant who attended both CHW-led sessions [Time frame: 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT07547631 · HUM00282928 · 1K01MD019325-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗