Enlace Familiar: Supporting the Mental Health of Latino A... | NCT07547631

Studies
Enlace Familiar: Supporting the Mental Health of Latino Adolescents

NCT07547631

Sponsor

University of Michigan

Status

Not yet recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

64Estimated

Phase

Not Applicable

Conditions

Mental Health

Interventions

Enlace Familiar

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1K01MD019325-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Apr 2028Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Apr 16, 2026

First Submission Date that Met QC Criteria

Apr 16, 2026

First Posted Date

Apr 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 23, 2026Actual

Name	Class
National Institute on Minority Health and Health Disparities (NIMHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

Is Enlace Familiar feasible and acceptable for Latino adolescents when delivered by CHWs?
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Enlace Familiar	Experimental	32 participants	Behavioral: Enlace Familiar
Standard care	No Intervention	32 participants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Fernanda L. Cross, Ph.D	Contact	(734) 945-3606		flcross@umich.edu

Name	Affiliation	Role
Fernanda Cross, Ph.D	University of Michigan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010549	Personal Satisfaction
D001519	Behavior