RECRUITING

Mental Health in Primary Care

Conditions

Depression, Anxiety Suicide Drug Use effectiveness-implementation type 1 hybrid trial Latinx mental health in primary care Latinx adolescent eHealth intervention Familias Unidas intervention sustainment parent-centered family functioning sexual risk behavior

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-26

Study Completion:2026-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05426057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).	* Families reporting plans to move out of the South Florida area during the study period.

Inclusion Criteria

Exclusion 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).

* Families reporting plans to move out of the South Florida area during the study period.

Contacts and Locations

Study Contact

Guillermo Prado, PhD

CONTACT

305-284-2002

gprado@miami.edu

Yannine Estrada, PhD

CONTACT

305-284-6191

yestrada@miami.edu

Principal Investigator

Guillermo Prado, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

C. Hendricks Brown, PhD

PRINCIPAL_INVESTIGATOR

Northwestern University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Miami

Guillermo Prado, PhD, PRINCIPAL_INVESTIGATOR, University of Miami
C. Hendricks Brown, PhD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-26

Study Completion Date2026-11-30

Study Record Updates

Study Start Date2022-04-26

Study Completion Date2026-11-30

Terms related to this study

Keywords Provided by Researchers

effectiveness-implementation type 1 hybrid trial
Latinx mental health in primary care
Latinx adolescent
eHealth intervention
Familias Unidas
intervention sustainment
parent-centered
family functioning
sexual risk behavior

Additional Relevant MeSH Terms

Depression, Anxiety
Suicide
Drug Use