Mental Health in Primary Care
Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
2 other identifiers
interventional
468
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 26, 2022
CompletedFirst Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
August 6, 2025
August 1, 2025
4.6 years
June 15, 2022
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Depression symptoms
Change in depression symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater depression symptom severity.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Anxiety symptoms
Change in anxiety symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater anxiety symptom severity.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Suicidality
Change in suicidality severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater suicidality symptom severity.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in drug use
Change in drug use will be reported as the number of days drug use was reported over the last 90 days.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Center for Epidemiologic Studies Depression Scale (CESD)
Change in depression symptoms will be assessed with the CESD. Scores range from 0 to 60 with higher scores indicating the presence of more symptoms.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary Outcomes (4)
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent Relationship with Peer Group
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in unprotected sexual behavior
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Study Arms (2)
eHealth Familias Unidas
EXPERIMENTALParticipants 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.
Prevention as Usual Control
NO INTERVENTIONIn this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female and male adolescents, who self-identify as Hispanic (or Latino(a))
- Adolescent between the ages of 12 - 16 years
- Adolescent living with an adult primary caregiver who is willing to participate
- 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.)
- 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).
You may not qualify if:
- Families reporting plans to move out of the South Florida area during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (17)
Jessie Trice Community Health Center
Miami, Florida, 33010, United States
Broward Community Health
Miami, Florida, 33021, United States
Community Health of South Florida
Miami, Florida, 33023, United States
Medlife Clinical Research
Miami, Florida, 33125, United States
Prime Care Health
Miami, Florida, 33134, United States
Care Resource
Miami, Florida, 33135, United States
Mailman for Child Devlopment
Miami, Florida, 33136, United States
Pediatric Mobile Clinic
Miami, Florida, 33136, United States
UM Pediatric Mobile Clinic
Miami, Florida, 33136, United States
UM UHealth Pediatrics at the Professional Arts Center
Miami, Florida, 33136, United States
Borinquean Medical Centers
Miami, Florida, 33137, United States
Belkys Bravo Clinic
Miami, Florida, 33145, United States
Nicklaus Children Hospital
Miami, Florida, 33155, United States
South Florida Pediatric Partners
Miami, Florida, 33173, United States
Pediatric Consultants of Kendall, P.A.
Miami, Florida, 33175, United States
UHealth Pediatrics at Kendall
Miami, Florida, 33176, United States
Banyan Health Systems
Miami, Florida, 33189, United States
Related Publications (1)
Estrada Y, Lozano A, Boga D, Tapia MI, Perrino T, Velazquez MR, Forster L, Torres N, Morales CV, Gwynn L, Beardslee WR, Brown CH, Prado G. eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings. PLoS One. 2023 Apr 18;18(4):e0283987. doi: 10.1371/journal.pone.0283987. eCollection 2023.
PMID: 37071612DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Prado, PhD
University of Miami
- PRINCIPAL INVESTIGATOR
C. Hendricks Brown, PhD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 15, 2022
First Posted
June 21, 2022
Study Start
April 26, 2022
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
August 6, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share