Cultural Adaptation of a SSI for Youth Anxiety

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT04729504
Collaborator
(none)
2,000
1
1
20.8
96.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adapted Project BRAVE
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth With Anxiety
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Adapted Project BRAVE Group

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

  • Principal Investigator: Jill Ehrenreich-May, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jill May Ehrenreich, Professor, Department of Psychology, University of Miami
ClinicalTrials.gov Identifier:
NCT04729504
Other Study ID Numbers:
  • 20210016
First Posted:
Jan 28, 2021
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022