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Cultural Adaptation of a SSI for Youth Anxiety

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04729504
Enrollment
2000
Registered
2021-01-28
Start date
2021-03-08
Completion date
2026-12-21
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

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.

Interventions

BEHAVIORALAdapted 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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety as measured by GAD-2Baseline, 2 weeksGeneralized 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 FASABaseline, 2 weeksFamily 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) Scores2 weeksThe 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

MeasureTime frameDescription
Perceived Change in Problem-Solving, and Preparedness to Manage Distress2 weeksTwo 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 ScoresBaseline, 2 weeksState 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.

Countries

United States

Contacts

Primary ContactHannah Grassie, BA
hlg54@miami.edu305-284-2712

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026