Mental Health Program for Young Adults

Recruiting at 2 trial locations

Overseen By Kiara L Moore, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Cognitive impairments, Unable to speak English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mental health program designed for young adults from racial and ethnic minority groups. Researchers aim to evaluate the effectiveness of a culturally-responsive orientation program in enhancing mental health services at a community clinic. Participants will engage in the "Just Do You" program, with some trying additional components (Component A, Component B, and Component C) to determine the most effective combination. Eligible participants have been using services at the participating clinic and identify with groups other than non-Hispanic White. As an unphased trial, this study provides participants the chance to contribute to innovative mental health solutions tailored to their communities.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the "Just Do You" program, the focus of this trial, has been part of earlier studies on young adults with serious mental health issues. Experts closely monitored these studies to ensure safety. So far, participants have handled the program well, with no major problems reported.

The trial will test different combinations of the program's parts (A, B, and C), but the main component has already been used safely in similar situations. This allows participants to feel confident about the program's safety when considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Just Do You" mental health program for young adults because it's designed to be highly individualized, combining various components (A, B, and C) tailored to each participant's needs. Unlike standard treatments like cognitive-behavioral therapy or medication, which follow a more uniform approach, this program allows for flexibility and personalization. By integrating different components, it can potentially address a wider range of mental health challenges more effectively. This innovative approach aims to empower young adults by giving them more control over their treatment process, which could lead to more meaningful and lasting improvements in mental health.

What evidence suggests that this trial's treatments could be effective for young adults' mental health?

Research shows that the "Just Do You" program helps young adults with serious mental illnesses become more involved in their treatment. In this trial, participants will receive the "Just Do You" program alone or with Components A, B, and/or C. Previous studies found that participants in the "Just Do You" program engaged more with their care than those receiving standard treatment. This suggests that young adults are more likely to continue using mental health services when they join this program. The program appears to facilitate their connection with mental health care. Overall, early results are promising for improving young adults' use of mental health services. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for racial and ethnic minority young adults experiencing conditions like psychosis, bipolar disorder, or depression. It's designed to help them engage with mental health services through a new program.

Inclusion Criteria

Enrolled in services at the partnering clinic site

From groups other than non-Hispanic White

Exclusion Criteria

I understand the consent process.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Just Do You program and assigned components for up to five weeks

5 weeks

Weekly sessions at the psychiatric rehabilitation program

Post-Intervention Assessment

Qualitative interviews and acceptability questionnaires are conducted immediately after the intervention

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for service utilization and engagement in mental health services

3 months

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Component A
• Component B
• Component C
• Just Do You

Trial Overview The study tests a culturally-responsive orientation program called 'Just Do You,' which includes various components (A, B, C) aimed at improving engagement in community mental health services over a 24-month period.

How Is the Trial Designed?

Group I: Just Do You-CB Experimental Treatment 3 Interventions

Just Do You plus Components C and B

Group II: Just Do You-C Experimental Treatment 2 Interventions

Just Do You plus Component C

Group III: Just Do You-B Experimental Treatment 2 Interventions

Just Do You plus Component B

Group IV: Just Do You-AC Experimental Treatment 3 Interventions

Just Do You plus Components A and C

Group V: Just Do You-ABC Experimental Treatment 4 Interventions

Just Do You plus Components A B and C

Group VI: Just Do You-AB Experimental Treatment 3 Interventions

Just Do You plus Components A and B

Group VII: Just Do You-A Experimental Treatment 2 Interventions

Just Do You plus Component A

Group VIII: Just Do You Active Control 1 Intervention

Just Do You Core Intervention

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03423212

Just Do You Program for Young Adults With Serious Mental ... The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7376671/

Engagement intervention versus treatment as usual for young ... Just Do You has the potential to fill a gap in the service system for young adults with serious mental illnesses, improving the seemingly ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X21002202

Outcomes of a Metaintervention to Improve Treatment ... The randomized explanatory trial indicated that young adults in Just Do You were more engaged in treatment than treatment as usual.

4. jahonline.org jahonline.org/article/S1054-139X(21)00220-2/fulltext

Outcomes of a Metaintervention to Improve Treatment ... The randomized explanatory trial indicated that young adults in Just Do You were more engaged in treatment than treatment as usual and that ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9742319/

Impact of A Brief Intervention to Improve Engagement in a ... This study examines the impact of Just Do You (JDY), an innovative intake-focused intervention designed to improve engagement in treatment and enhance personal ...

6. clinicaltrials.gov clinicaltrials.gov/show/NCT03423212

Just Do You Program for Young Adults With Serious Mental ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. samhsa.gov samhsa.gov/data/

SAMHSA Data SAMHSA collects data through multiple sources and surveys and provides access to public-use data files and documentation to support a better understanding of ...

8. cdc.gov cdc.gov/children-mental-health/data-research/index.html

Data and Statistics on Children's Mental Health This page provides data about indicators of positive mental health in children and mental health conditions that are most common in children.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5350637/

Young Adult Service Users' Experience with Mental Health ... We chose a qualitative interview method of data collection because interviews are suited for exploring people's perspectives on their health care experiences [ ...

10. dpi.wi.gov dpi.wi.gov/news/releases/2024/yrbs-student-mental-health-survey

New data shows Wisconsin youth continue navigating ... The Department of Public Instruction released data today showing Wisconsin students continue dealing with unprecedented mental health challenges.