Recruiting

Mental Health in Primary Care

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.

ClinicalTrials.gov IDNCT05426057

PhaseNA

Enrollment468

SponsorUniversity of Miami

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Anxiety, Suicide, Drug Use

About this study

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.

Primary outcomes

Depression symptoms (Baseline to 3 months, baseline to 6 months, baseline to 18 months)
Anxiety symptoms (Baseline to 3 months, baseline to 6 months, baseline to 18 months)
Suicidality (Baseline to 3 months, baseline to 6 months, baseline to 18 months)
Change in drug use (Baseline to 3 months, baseline to 6 months, baseline to 18 months)
Center for Epidemiologic Studies Depression Scale (CESD) (Baseline to 3 months, baseline to 6 months, baseline to 18 months)

Eligibility information

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.

Study locations

Jessie Trice Community Health Center, Miami, Florida 33010 United States
Broward Community Health, Miami, Florida 33021 United States
Community Health of South Florida, Miami, Florida 33023 United States
Medlife Clinical Research, Miami, Florida 33125 United States
Prime Care Health, Miami, Florida 33134 United States
Care Resource, Miami, Florida 33135 United States
Mailman for Child Devlopment, Miami, Florida 33136 United States
Pediatric Mobile Clinic, Miami, Florida 33136 United States
UM Pediatric Mobile Clinic, Miami, Florida 33136 United States
UM UHealth Pediatrics at the Professional Arts Center, Miami, Florida 33136 United States

Showing 10 of 17 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.