TrialPath
← Back to searchRecruiting

Mental Health in Primary Care

NCT05426057 · University of Miami
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
About this study
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.
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.
Study design
Enrollment target: 468 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2022-04-26
Estimated completion: 2026-11-30
Last updated: 2025-08-06
Interventions
Behavioral: eHealth Familias Unidas Mental Health
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)
Sponsor
University of Miami · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactGuillermo Prado, PhD · contact · gprado@miami.edu · 305-284-2002
ContactYannine Estrada, PhD · contact · yestrada@miami.edu · 305-284-6191
InvestigatorGuillermo Prado, PhD · principal_investigator, University of Miami
InvestigatorC. Hendricks Brown, PhD · principal_investigator, Northwestern University
All locations (17)
Jessie Trice Community Health CenterCompleted
Miami, Florida, United States
Broward Community HealthWithdrawn
Miami, Florida, United States
Community Health of South FloridaCompleted
Miami, Florida, United States
Medlife Clinical ResearchCompleted
Miami, Florida, United States
Prime Care HealthCompleted
Miami, Florida, United States
Care ResourceCompleted
Miami, Florida, United States
Mailman for Child DevlopmentRecruiting
Miami, Florida, United States
Pediatric Mobile ClinicRecruiting
Miami, Florida, United States
UM Pediatric Mobile ClinicRecruiting
Miami, Florida, United States
UM UHealth Pediatrics at the Professional Arts CenterRecruiting
Miami, Florida, United States
Borinquean Medical CentersRecruiting
Miami, Florida, United States
Belkys Bravo ClinicCompleted
Miami, Florida, United States
Nicklaus Children HospitalCompleted
Miami, Florida, United States
South Florida Pediatric PartnersCompleted
Miami, Florida, United States
Pediatric Consultants of Kendall, P.A.Completed
Miami, Florida, United States
UHealth Pediatrics at KendallRecruiting
Miami, Florida, United States
Banyan Health SystemsWithdrawn
Miami, Florida, United States
Mental Health in Primary Care · TrialPath