Step 1: Be Aware, Anxiety Prevention Intervention

NCT07044752 | Enrolling By Invitation

• 1 other identifier: 2000030293
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder

  Symptoms of Anxiety, Mild, Moderate, Severe

  30 days

Study Arms (1)

Anxiety Intervention

OTHER

5-educational session anxiety intervention for teens

Behavioral: Anxiety Prevention Intervention; Behavioral: Anxiety Intervention

Interventions

Anxiety Prevention Intervention BEHAVIORAL

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

Anxiety Intervention

Anxiety Intervention BEHAVIORAL

5-session social and behavioral intervention about managing anxiety symptoms

Anxiety Intervention

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Paterson College Achieve High School

Paterson, New Jersey, 07502, United States

Location

Study Officials

• Ijeoma Opara, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 1, 2025
• Study Start: May 7, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)