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Behavioral Intervention

Adapted Project BRAVE for Depression

N/A
Recruiting
Led By Jill Ehrenreich-May
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing an online intervention to help Latin, Haitian, and Haitian-American individuals with depression.

Who is the study for?
This trial is for caregivers of children aged 4-10 who are dealing with anxiety. Participants must be able to read and affirm consent language on an online platform. It's specifically designed to cater to the cultural and linguistic needs of Latin, Haitian, and Haitian-American communities.
What is being tested?
The study is testing 'Adapted Project BRAVE,' a culturally-tailored single session intervention (SSI) that lasts about 30 minutes and is delivered through an online platform, aiming to help youth with anxiety.
What are the potential side effects?
Since this intervention involves psychological guidance rather than medication, traditional side effects are not expected. However, discussing anxiety might temporarily increase distress or emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am the parent or legal guardian of a child aged 4-10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in anxiety as measured by GAD-2
Change in anxiety as measured by the FASA
Program Feedback Scale (PFS) Scores
Secondary study objectives
Change in State Hope Scale Scores
Perceived Change in Problem-Solving, and Preparedness to Manage Distress

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Adapted Project BRAVE GroupExperimental Treatment1 Intervention
Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
955 Previous Clinical Trials
426,853 Total Patients Enrolled
14 Trials studying Anxiety Disorders
2,748 Patients Enrolled for Anxiety Disorders
Jill Ehrenreich-MayPrincipal InvestigatorUniversity of Miami

Media Library

Adapted Project BRAVE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04729504 — N/A
Anxiety Disorders Research Study Groups: Adapted Project BRAVE Group
Anxiety Disorders Clinical Trial 2023: Adapted Project BRAVE Highlights & Side Effects. Trial Name: NCT04729504 — N/A
Adapted Project BRAVE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729504 — N/A
~386 spots leftby Dec 2025
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