NCT06508450

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Dec 2024Mar 2027

First Submitted

Initial submission to the registry

July 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 13, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

July 8, 2024

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Service utilization

    Assessed 3 months after baseline

  • Client Engagement in Child Protective Services Scale

    Assessed immediately after the intervention and 3 months after baseline

Study Arms (8)

Just Do You

ACTIVE COMPARATOR

Just Do You Core Intervention

Behavioral: Just Do You

Just Do You-A

EXPERIMENTAL

Just Do You plus Component A

Behavioral: Just Do YouBehavioral: Component A

Just Do You-B

EXPERIMENTAL

Just Do You plus Component B

Behavioral: Just Do YouBehavioral: Component B

Just Do You-C

EXPERIMENTAL

Just Do You plus Component C

Behavioral: Just Do YouBehavioral: Component C

Just Do You-AB

EXPERIMENTAL

Just Do You plus Components A and B

Behavioral: Just Do YouBehavioral: Component ABehavioral: Component B

Just Do You-AC

EXPERIMENTAL

Just Do You plus Components A and C

Behavioral: Just Do YouBehavioral: Component ABehavioral: Component C

Just Do You-CB

EXPERIMENTAL

Just Do You plus Components C and B

Behavioral: Just Do YouBehavioral: Component BBehavioral: Component C

Just Do You-ABC

EXPERIMENTAL

Just Do You plus Components A B and C

Behavioral: Just Do YouBehavioral: Component ABehavioral: Component BBehavioral: Component C

Interventions

Just Do YouBEHAVIORAL

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.

Just Do YouJust Do You-AJust Do You-ABJust Do You-ABCJust Do You-ACJust Do You-BJust Do You-CJust Do You-CB
Component ABEHAVIORAL

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

Just Do You-AJust Do You-ABJust Do You-ABCJust Do You-AC
Component BBEHAVIORAL

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

Just Do You-ABJust Do You-ABCJust Do You-BJust Do You-CB
Component CBEHAVIORAL

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

Just Do You-ABCJust Do You-ACJust Do You-CJust Do You-CB

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-34
  • From groups other than non-Hispanic White
  • Enrolled in services at the partnering clinic site

You may not qualify if:

  • Cognitive impairments (i.e., young adult cannot understand consent process)
  • Unable to comprehend and speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Jewish Board

The Bronx, New York, 10457, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic DisordersBipolar and Related DisordersDepressive Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersMood Disorders

Central Study Contacts

Kiara L Moore, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 18, 2024

Study Start

December 18, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 13, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations