Mental HealthNCT07547631
Enlace Familiar: Supporting the Mental Health of Latino Adolescents
A study testing Enlace Familiar in people with Mental Health, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Enlace Familiar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enlace Familiar Mental Health Intervention
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:
Read more
- 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.
- Conditions
- Mental Health
- Being tested
- Enlace Familiar
- Keywords
- Adolescent
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlace FamiliarBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enlace Familiar | Experimental | 32 participants Receives: Behavioral: Enlace Familiar |
| Standard care | No intervention | 32 participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 6 months
Secondary outcomes (4)
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.
Measured: 6 months
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
Measured: 6 months
Retention as measured by the percent of enrolled participants who completed the 8-week follow up
Measured: 6 months
Adherence as measured by the percent of participant who attended both CHW-led sessions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startJan 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Fernanda Cross, University of Michigan
- Investigators
- Fernanda Cross, Ph.D, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547631
- Sponsor's protocol ID
- HUM00282928
- Other IDs
- 1K01MD019325-01A1
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share the information publicly, but data may be shared with researchers upon request to the principal investigator.