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Clinical Trials/NCT06508450
NCT06508450
Recruiting
Not Applicable

Adapting and Testing A Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults

New York University1 site in 1 country80 target enrollmentDecember 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
New York University
Enrollment
80
Locations
1
Primary Endpoint
Participant acceptability questionnaire
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Researchers aim to test a brief culturally-responsive young adult orientation program for community mental health services. They will conduct a 24-month randomized trial with 80 young adults from racial and ethnic minority groups in a community-based mental health clinic.

Detailed Description

The study objective is to assess the feasibility and acceptability of three new culturally-responsive components added to the brief young adult engagement intervention called Just Do You. The new components incorporate techniques from the DSM-5 Cultural Formulation Interview (CFI) and creative arts therapy to increase culturally-responsive content in Just Do You, which demonstrated evidence of keeping young adults connected to their treatment in a prior trial. Components are designed to elicit relevant cultural characteristics, experiences, and perspectives of diverse young adults enrolled in psychiatric rehabilitation as part of the Just Do You orientation program. The investigators will examine whether the new culturally-responsive components improve engagement in mental health services and increase service utilization. A total of 80 young adults enrolled in an outpatient psychiatric rehabilitation program in New York will be recruited over 24 months to take part in a randomized full factorial pilot trial. Participants will be given a baseline assessment and randomly assigned to one of eight combinations of intervention components. Just Do You will be delivered first to all participants, with the assigned combination of new components to follow. The intervention will be delivered at the psychiatric rehabilitation program and will last up to five weeks for each participant, depending on the experimental condition. Outcome measures will be assessed at baseline, post-intervention, and 3-month follow up.

Registry
clinicaltrials.gov
Start Date
December 18, 2024
End Date
March 2027
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18-34
  • From groups other than non-Hispanic White
  • Enrolled in services at the partnering clinic site

Exclusion Criteria

  • Cognitive impairments (i.e., young adult cannot understand consent process)
  • Unable to comprehend and speak English

Outcomes

Primary Outcomes

Participant acceptability questionnaire

Time Frame: Immediately after the intervention

Self-report measure for assessing intervention acceptability from the perspectives of intervention recipients. Based on the theoretical framework of acceptability. Items are scored from 1 to 5. Possible total scores range from 9 to 45, with higher scores indicating greater acceptability.

Qualitative interviews

Time Frame: Immediately after the intervention

Interviews with participants to assess acceptability of Components A, B, and C

Intervention adherence

Time Frame: Baseline through study completion, an average of 2 years; repeated measure to assess change through study completion

Provider reported rate of intervention components completed by participants.

Secondary Outcomes

  • Service utilization(Assessed 3 months after baseline)
  • Client Engagement in Child Protective Services Scale(Assessed immediately after the intervention and 3 months after baseline)

Study Sites (1)

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