An interventional study of Just Do You and Component A in Psychosis, Bipolar and Related Disorders and Depressive Disorder, sponsored by New York University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by New York University · Not applicable, Interventional, and Other
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →New York University is the lead sponsor of 120 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Just Do You Core Intervention
Behavioral: Just Do You
Just Do You plus Component A
Behavioral: Just Do You · Behavioral: Component A
Just Do You plus Component B
Behavioral: Just Do You · Behavioral: Component B
Just Do You plus Component C
Behavioral: Just Do You · Behavioral: Component C
Just Do You plus Components A and B
Behavioral: Just Do You · Behavioral: Component A · Behavioral: Component B
Just Do You plus Components A and C
Behavioral: Just Do You · Behavioral: Component A · Behavioral: Component C
Just Do You plus Components C and B
Behavioral: Just Do You · Behavioral: Component B · Behavioral: Component C
Just Do You plus Components A B and C
Behavioral: Just Do You · Behavioral: Component A · Behavioral: Component B · Behavioral: Component C
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.
Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.
Content addresses identity-based motivations for on-going engagement with services and hope for the future.
Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.
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.
Time frame: Immediately after the intervention
Qualitative interviews
Interviews with participants to assess acceptability of Components A, B, and C
Time frame: Immediately after the intervention
Intervention adherence
Provider reported rate of intervention components completed by participants.
Time frame: Baseline through study completion, an average of 2 years; repeated measure to assess change through study completion
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.
Time frame: 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.
Time frame: Assessed immediately after the intervention and 3 months after baseline
Plan to share: No
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New York University