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OpenTrials
Enrolling by Invitation

NCT Number: NCT07044752

Step 1: Be Aware, Anxiety Prevention Intervention

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.

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Key information

Conditions

Age range

13 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paterson College Achieve High School

Paterson, New Jersey, 07502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anxiety Prevention Intervention

Behavioral

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

Anxiety Intervention

Behavioral

5-session social and behavioral intervention about managing anxiety symptoms

Primary outcomes

  1. Generalized Anxiety Disorder

    Time frame: 30 days

    Symptoms of Anxiety, Mild, Moderate, Severe

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Paterson Prevention Project Anxiety Prevention Intervention

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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