Actively Recruiting

Phase Not Applicable
Age: 12Years - 16Years
All Genders
Healthy Volunteers
ID05426057

Scaling a Parenting Evidence Based Intervention for Latinx Youth Mental Health in Primary Care

Led by University of Miami · Updated on 2025-08-06

468

Participants Needed

17

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating an enhanced version of eHealth Familias Unidas in a randomized rollout trial to reduce depression, anxiety, and suicidal behaviors among Hispanic youth aged 12 to 16 years. This effectiveness-implementation hybrid study involves 18 pediatric primary care clinics in South Florida and aims to support mental health by strengthening family and interpersonal protective factors. Participants in the intervention group will receive eHealth Familias Unidas-Mental Health, which includes nine video parent group sessions, one video adolescent session, and four family sessions delivered via web-conferencing over 13 weeks. The parent group sessions feature culturally relevant content and interactive exercises, while family sessions are led by trained pediatric staff. The control group will receive standard care services, including information and referrals, without the intervention. During the study, participants will be assessed at baseline, 3, 6, and 18 months for changes in depression and anxiety symptoms, suicidality, and drug use. Family functioning and communication will also be evaluated using questionnaires. The study will monitor adherence through the online sessions and measure outcomes with standardized scales like the Center for Epidemiologic Studies Depression Scale (CESD). Total participation lasts up to 18 months, allowing long-term follow-up of mental health and behavioral changes.

CONDITIONS

Brief Title

Mental Health in Primary Care

Who Can Participate

Age: 12Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female and male adolescents who self-identify as Hispanic or Latino(a)
  • Adolescents between 12 and 16 years old
  • Adolescents living with an adult primary caregiver willing to participate
  • Families must have broadband internet access on a device such as a smartphone, tablet, or computer
  • Families screening positive for poor family communication or youth with elevated depressive, anxiety symptoms, or history of suicide behavior
Not Eligible

You will not qualify if you...

  • Families planning to move out of the South Florida area during the study period

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual)

Outpatient Treatment

Duration - 13 weeks

Participants receive the eHealth Familias Unidas Mental Health program, consisting of 13 online sessions to promote mental health by strengthening family and interpersonal protective factors.

13 sessions via web-conferencing

Follow-up

Duration - Up to 18 months after treatment

Participants are monitored for mental health outcomes at multiple time points after the treatment period.

Assessments at 3, 6, and 18 months post-baseline

Trial Site Locations

Total: 17 locations

1

Jessie Trice Community Health Center

Miami, Florida, United States, 33010

Completed

2

Broward Community Health

Miami, Florida, United States, 33021

Withdrawn

3

Community Health of South Florida

Miami, Florida, United States, 33023

Completed

4

Medlife Clinical Research

Miami, Florida, United States, 33125

Completed

5

Prime Care Health

Miami, Florida, United States, 33134

Completed

6

Care Resource

Miami, Florida, United States, 33135

Completed

7

Mailman for Child Devlopment

Miami, Florida, United States, 33136

Actively Recruiting

8

Pediatric Mobile Clinic

Miami, Florida, United States, 33136

Actively Recruiting

9

UM Pediatric Mobile Clinic

Miami, Florida, United States, 33136

Actively Recruiting

10

UM UHealth Pediatrics at the Professional Arts Center

Miami, Florida, United States, 33136

Actively Recruiting

11

Borinquean Medical Centers

Miami, Florida, United States, 33137

Actively Recruiting

12

Belkys Bravo Clinic

Miami, Florida, United States, 33145

Completed

13

Nicklaus Children Hospital

Miami, Florida, United States, 33155

Completed

14

South Florida Pediatric Partners

Miami, Florida, United States, 33173

Completed

15

Pediatric Consultants of Kendall, P.A.

Miami, Florida, United States, 33175

Completed

16

UHealth Pediatrics at Kendall

Miami, Florida, United States, 33176

Actively Recruiting

17

Banyan Health Systems

Miami, Florida, United States, 33189

Withdrawn

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Research Team

G

Guillermo Prado, PhD

Y

Yannine Estrada, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings.

Yannine Estrada, Alyssa Lozano, Devina Boga...

https://pubmed.ncbi.nlm.nih.gov/37071612