An interventional study of Adapted Project BRAVE in Anxiety Disorders, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Miami · Not applicable, Interventional, and Supportive care
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.
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- Not meet all of the inclusion criteria.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
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.
Time frame: 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.
Time frame: Baseline, 2 weeks
Plan to share: No
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