Mental Health in Primary Care

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide; Drug Use; Depression, Anxiety
• Intervention / Treatment: Behavioral: eHealth Familias Unidas Mental Health

• Study Type: Interventional
• Enrollment (Estimated): 468
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillermo Prado, PhD; Phone Number: 305-284-2002; Email: gprado@miami.edu
• Study Contact Backup: Name: Yannine Estrada, PhD; Phone Number: 305-284-6191; Email: yestrada@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Mailman for Child Devlopment
      • Contact: Luiza Mali, PhD; Email: lvm852@med.miami.edu
    • Miami, Florida, United States, 33136
      • Recruiting
      • Pediatric Mobile Clinic
      • Contact: Lisa Gwynn, PhD
    • Miami, Florida, United States, 33136
      • Recruiting
      • UM Pediatric Mobile Clinic
      • Contact: Lisa Gwynn, MD; Email: lgwynn@med.miami.edu
    • Miami, Florida, United States, 33136
      • Recruiting
      • UM UHealth Pediatrics at the Professional Arts Center
      • Contact: Lourdes Q Forster, MD; Email: lforster@med.miami.edu
    • Miami, Florida, United States, 33137
      • Recruiting
      • Borinquean Medical Centers
      • Contact: Diego Shmuels, MD; Email: dshmuels@borinquenhealth.org
    • Miami, Florida, United States, 33176
      • Recruiting
      • UHealth Pediatrics at Kendall
      • Contact: Nicole Torres, PhD; Email: n.sosa@med.miami.edu
    • Miami, Florida, United States, 33021
      • Withdrawn
      • Broward Community Health
    • Miami, Florida, United States, 33189
      • Withdrawn
      • Banyan Health Systems
    • Miami, Florida, United States, 33010
      • Completed
      • Jessie Trice Community Health Center
    • Miami, Florida, United States, 33023
      • Completed
      • Community Health of South Florida
    • Miami, Florida, United States, 33125
      • Completed
      • Medlife Clinical Research
    • Miami, Florida, United States, 33134
      • Completed
      • Prime Care Health
    • Miami, Florida, United States, 33135
      • Completed
      • Care Resource
    • Miami, Florida, United States, 33145
      • Completed
      • Belkys Bravo Clinic
    • Miami, Florida, United States, 33155
      • Completed
      • Nicklaus Children Hospital
    • Miami, Florida, United States, 33173
      • Completed
      • South Florida Pediatric Partners
    • Miami, Florida, United States, 33175
      • Completed
      • Pediatric Consultants of Kendall, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: eHealth Familias Unidas Mental Health; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Family Functioning as assessed by the Parenting Practices Questionnaire	Change in family functioning will be reported using nine items from the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting. Scores range from 0 to 36.	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	Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale	Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in unprotected sexual behavior	Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.	Baseline to 3 months, baseline to 6 months, baseline to 18 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Guillermo Prado, PhD, University of Miami; Principal Investigator: C. Hendricks Brown, PhD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 14, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: family functioning; Familias Unidas; parent-centered; sexual risk behavior; effectiveness-implementation type 1 hybrid trial; Latinx mental health in primary care; Latinx adolescent; eHealth intervention; intervention sustainment
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Self-Injurious Behavior; Behavior; Anxiety Disorders; Suicide; Depression
• Other Study ID Numbers: 20210286; 1R01MH124718-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No