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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
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 belowSelect...
I am the parent or legal guardian of a child aged 4-10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
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
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.
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Who is running the clinical trial?
University of MiamiLead Sponsor
935 Previous Clinical Trials
420,217 Total Patients Enrolled
14 Trials studying Anxiety Disorders
2,748 Patients Enrolled for Anxiety Disorders
Jill Ehrenreich-MayPrincipal InvestigatorUniversity of Miami
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am the parent or legal guardian of a child aged 4-10.You do not meet all the requirements to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Adapted Project BRAVE Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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