Mental Health in Primary Care

NCT05426057 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2025-08-06

No results posted yet for this study

Summary

The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.

Conditions

  • Depression, Anxiety
  • Suicide
  • Drug Use

Interventions

BEHAVIORAL

eHealth Familias Unidas Mental Health

eHealth Familias Unidas is a program designed to target mental health and suicide ideation and behavior. It focuses on promoting mental health by strengthening family and interpersonal protective factors. The program is provided online over a total of 13 sessions: 9 video parent group sessions, each lasting 20-40 minutes in Spanish and 4 web family sessions lasting 45 minutes in either Spanish or English, depending on participant language preference. The video parent group sessions consist of: 1) culturally syntonic telenovela/soap opera series, 2) videotaped parent group discussions, 3) interactive exercises. Web family sessions will be conducted by a trained pediatric staff member.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • University of Miami

    lead OTHER

Principal Investigators

  • Guillermo Prado, PhD · University of Miami

  • C. Hendricks Brown, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-26
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05426057 on ClinicalTrials.gov