Back to resultsCultural Adaptation of a SSI for Youth Anxiety
Primary Purpose
Anxiety Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Project BRAVE
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety Disorders
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not meet all of the inclusion criteria.
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adapted Project BRAVE Group
Arm Description
Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04729504
First Posted
January 12, 2021
Last Updated
November 28, 2022
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT04729504
Brief Title
Cultural Adaptation of a SSI for Youth Anxiety
Official Title
Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth With Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 21, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Project BRAVE Group
Arm Type
Other
Arm Description
Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Project BRAVE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety as measured by GAD-2
Description
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.
Time Frame
Baseline, 2 weeks
Title
Change in anxiety as measured by the FASA
Description
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.
Time Frame
Baseline, 2 weeks
Title
Program Feedback Scale (PFS) Scores
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Perceived Change in Problem-Solving, and Preparedness to Manage Distress
Description
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.
Time Frame
2 weeks
Title
Change in State Hope Scale Scores
Description
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.
Time Frame
Baseline, 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Not meet all of the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah Grassie, BA
Phone
305-284-2712
Email
hlg54@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Grassie
Phone
305-284-2712
Email
hlg54@miami.edu
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May
12. IPD Sharing Statement
Plan to Share IPD
No
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Cultural Adaptation of a SSI for Youth Anxiety
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