Cultural Adaptation of a SSI for Youth Anxiety

Anxiety Disorders Clinical Trial

Official title:

Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth With Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04729504
• Other study ID #: 20210016
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 21, 2024

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: Hannah Grassie, BA
• Phone: 305-284-2712
• Email: hlg54[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 21, 2024
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Adapted Project BRAVE
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Perceived Change in Problem-Solving, and Preparedness to Manage Distress	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.	2 weeks
Secondary	Change in State Hope Scale Scores	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.	Baseline, 2 weeks