Clinical Trial

Step 1: Be Aware, Anxiety Prevention Intervention

Enrolling by Invitation
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Record status
This record was last updated July 1, 2025 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
Youth of color, particularly in urban communities, face disproportionate anxiety levels due to systemic inequities, including exposure to violence, economic instability, and neighborhood disadvantage. Despite increased need, these communities often lack accessible, culturally relevant mental health interventions. This study presents a protocol for a community-driven anxiety prevention intervention tailored to urban youth of color using community-based participatory research (CBPR) methods. The intervention, co-developed with community partners and youth includes five structured weekly sessions on psychoeducation, coping skills, and role-playing exercises. Facilitators trained in social work or psychology will deliver the intervention, with at least one facilitator from the target community ensuring cultural relevance. Recruitment will occur through collaboration with a local high school, with counselors identifying high-risk youth. Data from pilot interventional trial will be collected at baseline, post-intervention, and a three-month follow-up using validated measures such as the Generalized Anxiety Disorder-7 (GAD-7) scale. This study highlights community-based participatory research approach in addressing mental health disparities among urban youth. By incorporating community perspectives, the intervention ensures cultural alignment. Findings will inform future adaptations of community centered anxiety interventions and contribute to knowledge on improving mental health accessibility for marginalized youth. If effective, this model could be expanded to support youth in other under-resourced communities.
Trial Details
NCT Number NCT07044752
Lead Sponsor Yale University
Conditions Moderate Anxiety
Enrollment 50 participants
Start Date 2025-05-07
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-01