Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT05426057

Conditions

Depression, Anxiety

Suicide

Drug Use

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Accepted

Interventions

eHealth Familias Unidas Mental Health

Study Details

Brief 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

Study ID

NCT05426057

Start date

Apr 26, 2022

Status verified date

Aug, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 16

Healthy Volunteers: Accepted

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 Design

Enrollment

468 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: eHealth Familias Unidas

Participants in this group will receive eHealth Familias Unidas-Mental Health. The intervention consists of nine video parent group sessions, one video adolescent session, and four family sessions (parents participate in a total of 13 sessions, adolescents participate in a total of five sessions) that will be delivered by a facilitator to the parent-child dyad via web-conferencing software across 13 weeks.

no intervention: Prevention as Usual Control

In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.

Interventions

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 outcome measure

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

Central Contacts and Locations

Central contacts

Guillermo Prado, PhD

305-284-2002gprado@miami.edu

Yannine Estrada, PhD

305-284-6191yestrada@miami.edu

Locations

Mailman for Child Devlopment

Recruiting

Miami, Florida, United States, 33136

Contacts

Luiza Mali, PhD

lvm852@med.miami.edu

Pediatric Mobile Clinic

Recruiting

Miami, Florida, United States, 33136

UM Pediatric Mobile Clinic

Recruiting

Miami, Florida, United States, 33136

Contacts

Lisa Gwynn, MD

lgwynn@med.miami.edu

UM UHealth Pediatrics at the Professional Arts Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Lourdes Q Forster, MD

lforster@med.miami.edu

Borinquean Medical Centers

Recruiting

Miami, Florida, United States, 33137

Contacts

Diego Shmuels, MD

dshmuels@borinquenhealth.org

UHealth Pediatrics at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Nicole Torres, PhD

n.sosa@med.miami.edu

More Information

Sponsor

University of Miami

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • effectiveness-implementation type 1 hybrid trial
  • Latinx mental health in primary care
  • Latinx adolescent
  • eHealth intervention
  • Familias Unidas
  • intervention sustainment
  • parent-centered
  • family functioning
  • sexual risk behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-18.