Cultural Adaptation of a SSI for Youth Anxiety

NCT04729504 | Recruiting

• 1 other identifier: 20210016
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (3)

• Change in anxiety as measured by GAD-2

  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.

  Baseline, 2 weeks

• Change in anxiety as measured by the FASA

  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.

  Baseline, 2 weeks

• Program Feedback Scale (PFS) Scores

  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.

  2 weeks

Secondary Outcomes (2)

• Perceived Change in Problem-Solving, and Preparedness to Manage Distress

  2 weeks

• Change in State Hope Scale Scores

  Baseline, 2 weeks

Study Arms (1)

Adapted Project BRAVE Group

OTHER

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

Behavioral: Adapted Project BRAVE

Interventions

Adapted Project BRAVE BEHAVIORAL

A culturally and linguistically adapted Project BRAVE is web-based single session intervention that is about 30 minutes in length. The session is designed to focus on targeting child anxiety symptoms in the multilingual and diverse families in Miami-Dade.

Adapted Project BRAVE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jill Ehrenreich-May

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Grassie, BA

CONTACT

305-284-2712; hlg54@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychology

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 28, 2021
• Study Start: March 8, 2021
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)