Clinical trial Recruiting at 6 sites Interventional Ages 12 to 16

Improving mental health for Hispanic adolescents in primary care

Official title: Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care

Run by University of Miami · NCT05426057 · Data updated 2026-11-12

This study is testing a new online program called Familias Unidas to see if it can help Hispanic teens aged 12 to 16 feel less depressed, anxious, and suicidal while getting support from their families.

More Suicide trials

Quick facts

Study typeInterventional
Ages12 Years to 16 Years
SexAll
Enrollment468 (estimated)
SponsorUniversity of Miami
Academic / other
Locations17 sites (Miami, Florida and 16 other locations)
StatusRecruiting
StartedApril 26, 2022
Main results expectedApril 30, 2028
Study endsApril 30, 2028
Registry record updatedAugust 18, 2026
Trial IDNCT05426057 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Hispanic adolescents aged 12 to 16 who are experiencing mental health challenges and have supportive caregivers.

Probably not a fit

Patients who do not self-identify as Hispanic or who plan to move out of the study area during the trial may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates an enhanced eHealth intervention called Familias Unidas aimed at reducing symptoms of depression, anxiety, and suicidal behavior among Hispanic adolescents aged 12 to 16. Conducted in 18 pediatric primary care clinics in South Florida, the study employs a randomized rollout design to assess the effectiveness and implementation of this intervention. Participants must have access to broadband internet and be living with a caregiver willing to engage in the program. The study focuses on families with poor communication or youth exhibiting elevated mental health symptoms.

Why it matters

Potential benefit: If successful, this intervention could significantly improve mental health outcomes for Hispanic adolescents in primary care settings.

How similar studies have gone: Other studies have shown promise in using eHealth interventions for mental health, particularly in minority populations, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Mailman for Child Devlopment
    Miami, Florida, United States
    Recruiting
  • Pediatric Mobile Clinic
    Miami, Florida, United States
    Recruiting
  • UM Pediatric Mobile Clinic
    Miami, Florida, United States
    Recruiting
  • UM UHealth Pediatrics at the Professional Arts Center
    Miami, Florida, United States
    Recruiting
  • Borinquean Medical Centers
    Miami, Florida, United States
    Recruiting
  • UHealth Pediatrics at Kendall
    Miami, Florida, United States
    Recruiting
Show 11 more locations
  • Jessie Trice Community Health Center
    Miami, Florida, United States
    Completed
  • Broward Community Health
    Miami, Florida, United States
    Withdrawn
  • Community Health of South Florida
    Miami, Florida, United States
    Completed
  • Medlife Clinical Research
    Miami, Florida, United States
    Completed
  • Prime Care Health
    Miami, Florida, United States
    Completed
  • Care Resource
    Miami, Florida, United States
    Completed
  • Belkys Bravo Clinic
    Miami, Florida, United States
    Completed
  • Nicklaus Children Hospital
    Miami, Florida, United States
    Completed
  • South Florida Pediatric Partners
    Miami, Florida, United States
    Completed
  • Pediatric Consultants of Kendall, P.A.
    Miami, Florida, United States
    Completed
  • Banyan Health Systems
    Miami, Florida, United States
    Withdrawn

Study contacts

  • Principal investigator: Guillermo Prado, PhD — University of Miami
  • Study coordinator: Guillermo Prado, PhD
  • Email: gprado@miami.edu
  • Phone: 305-284-2002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.