RECRUITING Not applicable ClinicalTrials.gov

Mental Health in Primary Care

Sponsor: University of Miami • ClinicalTrials.gov ID: NCT05426057

Registry updated: 2026-08-18

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Description

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.

Interventions

eHealth Familias Unidas Mental Health (Behavioral)
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.

Eligibility criteria

Inclusion Criteria: 1. Female and male adolescents, who self-identify as Hispanic (or Latino(a)) 2. Adolescent between the ages of 12 - 16 years 3. Adolescent living with an adult primary caregiver who is willing to participate 4. Families must have broadband internet access on a device, including (but not limited to) a smartphone, iPad, tablet, computer at their home or other location (e.g., school, library, etc.) 5. Families screening positive on poor family communication (a score of less than 75 on the communication measure; see measures) or youth reporting elevated depressive or anxiety symptom scores (defined as 70 to 90 on the K-CAT) or a history of suicide behavior (ideation or attempts). Exclusion Criteria: * Families reporting plans to move out of the South Florida area during the study period.

Conditions

Depression, Anxiety Suicide Drug Use

Locations

Jessie Trice Community Health Center — Miami, Florida, United States
Broward Community Health — Miami, Florida, United States
Community Health of South Florida — Miami, Florida, United States
Medlife Clinical Research — Miami, Florida, United States
Prime Care Health — Miami, Florida, United States
Care Resource — Miami, Florida, United States
Mailman for Child Devlopment — Miami, Florida, United States
Pediatric Mobile Clinic — Miami, Florida, United States
UM Pediatric Mobile Clinic — Miami, Florida, United States
UM UHealth Pediatrics at the Professional Arts Center — Miami, Florida, United States
Borinquean Medical Centers — Miami, Florida, United States
Belkys Bravo Clinic — Miami, Florida, United States
Nicklaus Children Hospital — Miami, Florida, United States
South Florida Pediatric Partners — Miami, Florida, United States
Pediatric Consultants of Kendall, P.A. — Miami, Florida, United States
UHealth Pediatrics at Kendall — Miami, Florida, United States
Banyan Health Systems — Miami, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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