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NCT Number: NCT06508450

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.

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Key information

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Jewish Board

The Bronx, New York, 10457, United States

Location status: Recruiting

Location contact

Christina Mango

CONTACT

[email protected]

718-282-3425

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Just Do You

Behavioral

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.

Component A

Behavioral

Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.

Component B

Behavioral

Content addresses identity-based motivations for on-going engagement with services and hope for the future.

Component C

Behavioral

Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.

Primary outcomes

  1. 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.

  2. Qualitative interviews

    Time frame: Immediately after the intervention

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

  3. 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

  1. Service utilization

    Time frame: Assessed 3 months after baseline

    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.

  2. Client Engagement in Child Protective Services Scale

    Time frame: Assessed immediately after the intervention and 3 months after baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kiara L Moore, PhD

CONTACT

[email protected]

212-998-5900

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Mar 13, 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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