Cultural Adaptation of a SSI for Youth Anxiety

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Adapted Project BRAVE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adapted Project BRAVE Group<br>Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE. | Behavioral: Adapted Project BRAVE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |