Mental Health in Primary Care

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05426057
Status
Recruiting
Apply to this trial

Conditions

  • Depression, Anxiety
  • Drug Use
  • Suicide

Eligibility Criteria

Sex
ALL
Age
12 Years - 16 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Apr 26, 2022
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Depression symptoms [ Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Banyan Health SystemsMiamiFlorida33189-
Belkys Bravo ClinicMiamiFlorida33145-
Borinquean Medical CentersMiamiFlorida33137
Diego Shmuels, MD
[email protected]
Broward Community HealthMiamiFlorida33021-
Care ResourceMiamiFlorida33135-
Community Health of South FloridaMiamiFlorida33023-
Jessie Trice Community Health CenterMiamiFlorida33010-
Mailman for Child DevlopmentMiamiFlorida33136
Luiza Mali, PhD
[email protected]
Medlife Clinical ResearchMiamiFlorida33125-
Nicklaus Children HospitalMiamiFlorida33155-
Pediatric Consultants of Kendall, P.A.MiamiFlorida33175-
Pediatric Mobile ClinicMiamiFlorida33136
Lisa Gwynn, PhD
Prime Care HealthMiamiFlorida33134-
South Florida Pediatric PartnersMiamiFlorida33173-
UHealth Pediatrics at KendallMiamiFlorida33176
Nicole Torres, PhD
[email protected]
UM Pediatric Mobile ClinicMiamiFlorida33136
Lisa Gwynn, MD
[email protected]
UM UHealth Pediatrics at the Professional Arts CenterMiamiFlorida33136
Lourdes Q Forster, MD
[email protected]

Find similar trials in Miami, FL

By research site
Banyan Health Systems· Miami, FLBelkys Bravo Clinic· Miami, FLBorinquean Medical Centers· Miami, FLBroward Community Health· Miami, FLCare Resource· Miami, FLCommunity Health of South Florida· Miami, FL

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