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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Bipolar and Related Disorders; Psychosis
• Intervention / Treatment: Behavioral: Just Do You; Behavioral: Component A; Behavioral: Component B; Behavioral: Component C

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiara L Moore, PhD; Phone Number: 212-998-5900; Email: kiara.moore@nyu.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10457
      • Recruiting
      • The Jewish Board
      • Contact: Christina Mango; Phone Number: 718-282-3425; Email: CMango@jbfcs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Just Do You; Just Do You Core Intervention	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.
Experimental: Just Do You-A; Just Do You plus Component A	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component A; Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.
Experimental: Just Do You-B; Just Do You plus Component B	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component B; Content addresses identity-based motivations for on-going engagement with services and hope for the future.
Experimental: Just Do You-C; Just Do You plus Component C	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component C; Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.
Experimental: Just Do You-AB; Just Do You plus Components A and B	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component A; Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.; Behavioral: Component B; Content addresses identity-based motivations for on-going engagement with services and hope for the future.
Experimental: Just Do You-AC; Just Do You plus Components A and C	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component A; Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.; Behavioral: Component C; Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.
Experimental: Just Do You-CB; Just Do You plus Components C and B	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component B; Content addresses identity-based motivations for on-going engagement with services and hope for the future.; Behavioral: Component C; Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.
Experimental: Just Do You-ABC; Just Do You plus Components A B and C	Behavioral: Just Do You; Just Do You Core Intervention utilizes creative arts and a provider team of a licensed clinician and professional peer to increase young adult engagement in adult outpatient mental health programs. Content addresses recovery, advantages of using mental health services, working with providers, stigma, and mental health literacy.; Behavioral: Component A; Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.; Behavioral: Component B; Content addresses identity-based motivations for on-going engagement with services and hope for the future.; Behavioral: Component C; Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant acceptability questionnaire	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.	Immediately after the intervention
Qualitative interviews	Interviews with participants to assess acceptability of Components A, B, and C	Immediately after the intervention
Intervention adherence	Provider reported rate of intervention components completed by participants.	Baseline through study completion, an average of 2 years; repeated measure to assess change through study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Service utilization	Provider reported service utilization. Total number of contacts between participant and service providers starting 1 month before baseline though 3-month follow up to assess change in participant engagement.	Assessed 3 months after baseline
Client Engagement in Child Protective Services Scale	This scale is altered to measure young adult engagement in mental health services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement.	Assessed immediately after the intervention and 3 months after baseline

Collaborators and Investigators

• Sponsor: New York University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depressive Disorder
• Other Study ID Numbers: K23MH132814 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No