Improving mental health for Hispanic adolescents in primary care
Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
NA · University of Miami · NCT05426057
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.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 468 (estimated) |
| Ages | 12 Years to 16 Years |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 17 sites (Miami, Florida and 16 other locations) |
| Trial ID | NCT05426057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Hispanic adolescents aged 12 to 16 who are experiencing mental health challenges and have supportive caregivers.
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.
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 performed: Other studies have shown promise in using eHealth interventions for mental health, particularly in minority populations, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Miami, Florida and 16 other 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)
- 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)
- 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)
- UHealth Pediatrics at Kendall — Miami, Florida, United States (RECRUITING)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Anxiety, Suicide, Drug Use, effectiveness-implementation type 1 hybrid trial, Latinx mental health in primary care, Latinx adolescent, eHealth intervention, Familias Unidas