Cultural Adaptation of a SSI for Youth Anxiety

Not Applicable

Recruiting

• Conditions: Anxiety Disorders
• Interventions: Behavioral: Adapted Project BRAVE

• Registration Number: NCT04729504
• Lead Sponsor: University of Miami

Brief Summary

The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-28
• Study Start: 2021-03-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-21
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
2. Affirm that they have read the consent language and study overview on REDCap by checking a box.

Exclusion Criteria

• Not meet all of the inclusion criteria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapted Project BRAVE Group	Adapted Project BRAVE	Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.

Primary Outcome Measures

Name	Time	Method
Change in anxiety as measured by the FASA	Baseline, 2 weeks	Family Accommodation Scale - Anxiety (FASA) is a 9-item scale of measuring caregiver accommodation behaviors (modification of routines, facilitating avoidance, etc.) in light of youth anxiety. It has a total score ranging from 0 to 36 with the higher score indicating more frequent parental accommodation.
Program Feedback Scale (PFS) Scores	2 weeks	The PFS is a reliable, valid measure of the perceived acceptability of single-session interventions. It asks participants to rate acceptability and feasibility of an SSI they just completed. It has a total score ranging from 0 to 28 with the higher score indicating perceived acceptability and feasibility of the program.
Change in anxiety as measured by GAD-2	Baseline, 2 weeks	Generalized Anxiety Disorder 2-item (GAD-2) Scale has a total score ranging from 0 to 6 with a score of 3 being the cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.

Secondary Outcome Measures

Name	Time	Method
Change in State Hope Scale Scores	Baseline, 2 weeks	State Hope Scale is a 6-item self-report scale designed to evaluate hope in adolescents and adults, including two reliable subscales: agency and pathways. It has a total score ranging from 6 to 48 with the higher scores representing higher hope levels.
Perceived Change in Problem-Solving, and Preparedness to Manage Distress	2 weeks	Two questions (Schleider et al., 2020) will be used to assess change in ability to solve problems, and ability to manage distress. Participants will be asked, "to what extent are you able to solve the problems \[with your child's anxiety\] facing right now?", and "how prepared do you feel to manage \[your child with\] distressing situations?" It has a total score ranging from 2 to 10, with a higher score indicating better ability to solve problems, and to manage distress.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States