Step 1: Be Aware, Anxiety Prevention Intervention

NCT ID: NCT07044752

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2025-08-30

Brief 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.

Conditions

Moderate Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Anxiety Intervention

5-educational session anxiety intervention for teens

Group Type: OTHER

Anxiety Prevention Intervention

Intervention Type: BEHAVIORAL

community and school based, delivered by peers from the community to educate and lower anxiety symptoms among youth

Anxiety Intervention

Intervention Type: BEHAVIORAL

5-session social and behavioral intervention about managing anxiety symptoms

Interventions

Anxiety Prevention Intervention

community and school based, delivered by peers from the community to educate and lower anxiety symptoms among youth

Intervention Type: BEHAVIORAL

Anxiety Intervention

5-session social and behavioral intervention about managing anxiety symptoms

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• able to speak and read in English
• reside in Paterson

Exclusion Criteria

• English is not first language and cannot read or write English
• Does not have residence in Paterson
• Has not provided consent to participate in study

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ijeoma Opara, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Paterson College Achieve High School

Paterson, New Jersey, United States

Countries

United States

Other Identifiers

2000030293

Identifier Type: -

Identifier Source: org_study_id