PsychosisNCT06508450
A Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults
A study testing Just Do You, Component A and Component B in people with Psychosis and Bipolar and Related Disorders, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 34 years
- Conditions the study is for
- Psychosis, Bipolar and Related Disorders, Depressive Disorder
- What is being tested?
- Just Do You, Component A and Component B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-34
- From groups other than non-Hispanic White
- Enrolled in services at the partnering clinic site
Who cannot join
- Cognitive impairments (i.e., young adult cannot understand consent process)
- Unable to comprehend and speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Jewish Board
The Bronx, New York, 10457
Christina Mango, 718-282-3425, CMango@jbfcs.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Just Do You, Component A, Component B, Component C
- Medical subject headings
- Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just Do YouBehavioural
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 ABehavioural
Content addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services.
Component BBehavioural
Content addresses identity-based motivations for on-going engagement with services and hope for the future.
Component CBehavioural
Content addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Just Do You | Active comparator | Just Do You Core Intervention Receives: Behavioral: Just Do You |
| Just Do You-A | Experimental | Just Do You plus Component A Receives: Behavioral: Just Do You; Behavioral: Component A |
| Just Do You-B | Experimental | Just Do You plus Component B Receives: Behavioral: Just Do You; Behavioral: Component B |
| Just Do You-C | Experimental | Just Do You plus Component C Receives: Behavioral: Just Do You; Behavioral: Component C |
| Just Do You-AB | Experimental | Just Do You plus Components A and B Receives: Behavioral: Just Do You; Behavioral: Component A; Behavioral: Component B |
| Just Do You-AC | Experimental | Just Do You plus Components A and C Receives: Behavioral: Just Do You; Behavioral: Component A; Behavioral: Component C |
| Just Do You-CB | Experimental | Just Do You plus Components C and B Receives: Behavioral: Just Do You; Behavioral: Component B; Behavioral: Component C |
| Just Do You-ABC | Experimental | Just Do You plus Components A B and C Receives: Behavioral: Just Do You; Behavioral: Component A; Behavioral: Component B; Behavioral: Component C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
Qualitative interviews
Interviews with participants to assess acceptability of Components A, B, and C
Measured: Immediately after the intervention
Intervention adherence
Provider reported rate of intervention components completed by participants.
Measured: Baseline through study completion, an average of 2 years; repeated measure to assess change through study completion
Secondary outcomes (2)
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.
Measured: 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.
Measured: Assessed immediately after the intervention and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start18 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508450
- Sponsor's protocol ID
- K23MH132814
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moore KL, Rodwin AH, Gwadz M, Chang DF, Collins LM, Munson MR. A Brief Engagement Intervention Adapted for Racial and Ethnic Minority Young Adults in Mental Health Services: Protocol for a Pilot Optimization Trial. JMIR Res Protoc. 2025 Jun 17;14:e68885. doi: 10.2196/68885.
PubMed 40527500
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Testing A Mental Health Services Engagement Program for Racial and Ethnic Minority Young Adults
- ClinicalTrials.gov ID
- NCT06508450
- Acronym / sponsor ID
- K23MH132814
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Just Do You | Active comparator | Behavioral: Just Do YouJust Do You Core Intervention |
| Just Do You-A | Experimental | Behavioral: Just Do You, Behavioral: Component AJust Do You plus Component A |
| Just Do You-B | Experimental | Behavioral: Just Do You, Behavioral: Component BJust Do You plus Component B |
| Just Do You-C | Experimental | Behavioral: Just Do You, Behavioral: Component CJust Do You plus Component C |
| Just Do You-AB | Experimental | Behavioral: Just Do You, Behavioral: Component A, Behavioral: Component BJust Do You plus Components A and B |
| Just Do You-AC | Experimental | Behavioral: Just Do You, Behavioral: Component A, Behavioral: Component CJust Do You plus Components A and C |
| Just Do You-CB | Experimental | Behavioral: Just Do You, Behavioral: Component B, Behavioral: Component CJust Do You plus Components C and B |
| Just Do You-ABC | Experimental | Behavioral: Just Do You, Behavioral: Component A, Behavioral: Component B, Behavioral: Component CJust Do You plus Components A B and C |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-34
- From groups other than non-Hispanic White
- Enrolled in services at the partnering clinic site
Key exclusion criteria (2 listed)
- Cognitive impairments (i.e., young adult cannot understand consent process)
- Unable to comprehend and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Just Do YouJust 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. | Behavioural | Just Do You, Just Do You-A, Just Do You-AB, Just Do You-ABC, Just Do You-AC, Just Do You-B, Just Do You-C, Just Do You-CB |
| Component AContent addresses participant cultural identities and how they may be barriers and facilitators to on-going engagement with services. | Behavioural | Just Do You-A, Just Do You-AB, Just Do You-ABC, Just Do You-AC |
| Component BContent addresses identity-based motivations for on-going engagement with services and hope for the future. | Behavioural | Just Do You-AB, Just Do You-ABC, Just Do You-B, Just Do You-CB |
| Component CContent addresses community and environmental barriers and facilitators to on-going engagement with services and self-efficacy. | Behavioural | Just Do You-ABC, Just Do You-AC, Just Do You-C, Just Do You-CB |
Primary outcome
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.
2 secondary outcomes
Service utilization
Time frame: Assessed 3 months after baseline
Client Engagement in Child Protective Services Scale
Time frame: Assessed immediately after the intervention and 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 40527500Moore KL, Rodwin AH, Gwadz M, Chang DF, Collins LM, Munson MR. A Brief Engagement Intervention Adapted for Racial and Ethnic Minority Young Adults in Mental Health Services: Protocol for a Pilot Optimization Trial. JMIR Res Protoc. 2025 Jun 17;14:e68885. doi: 10.2196/68885.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just Do You, Component A and Component B in people with Psychosis and Bipolar and Related Disorders, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiara L Moore, PhD (212-998-5900, kiara.moore@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant acceptability questionnaire (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06508450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.