NCT03423212

Brief Summary

Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). 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 young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care. This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 4, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2020

Completed
Last Updated

November 3, 2022

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

January 4, 2018

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Adherence to PROS program

    Past week attendance to mental health appointments at PROS

    Assessed 4 weeks following baseline

  • Adherence to PROS program

    Past week attendance to mental health appointments at PROS

    Assessed 3 months following baseline

Secondary Outcomes (4)

  • Adherence to medication

    Assessed 4 weeks following baseline

  • Adherence to medication

    Assessed 3 months following baseline

  • Client Engagement in Child Protective Services Scale

    Assessed 4 weeks following baseline

  • Client Engagement in Child Protective Services Scale

    Assessed 3 months following baseline

Other Outcomes (9)

  • Center for Epidemiological Studies Depression Scale

    Assessed 3 months following baseline

  • Global Measure of Perceived Stress

    Assessed 4 weeks following baseline

  • Inventory of Attitudes Toward Seeking Mental Health Services

    Assessed 4 weeks following baseline

  • +6 more other outcomes

Study Arms (3)

Experimental Condition

EXPERIMENTAL

Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere.

Behavioral: Just Do You

Treatment as Usual Condition

NO INTERVENTION

Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention.

Active Control Condition

ACTIVE COMPARATOR

Participants assigned to the active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.

Behavioral: Active Control

Interventions

Just Do YouBEHAVIORAL

Just Do You is an intervention designed to keep young adults connected to their professional behavioral health treatments. It is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to increase young adult engagement in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The first session consists of the following components: 1) Welcome; Group Guidelines, Purpose, 2) Discuss Recovery Principles; Narrative of Role Model; 3) Video of Celebrity Service User and Discussion, and 4) Recovery Goals (and role of services in that). The second session consists of: 1) What are services \& how can they help? 2) Visual art exercise -- Cause of SMI and validation, 3) Maintaining my Medicaid Insurance, and 4) Discussion of Systemic Barriers.

Experimental Condition
Active ControlBEHAVIORAL

The active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.

Active Control Condition

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • between the ages of 18 and 28
  • living with a serious mental illness (i.e., mood, anxiety, schizophrenia-spectrum)
  • attending personalized recovery-oriented services (PROS)
  • formerly involved with public systems of care

You may not qualify if:

  • cognitive impairments (i.e., young adult cannot understand consent process or IQ\<70)
  • non-English speaking (we will include individuals whose primary language is not English, but are able to comprehend and speak English).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mt Eden Personalized Recovery Oriented Services

New York, New York, 10457, United States

Location

Related Publications (2)

  • Munson MR, Jaccard J, Scott LD Jr, Moore KL, Narendorf SC, Cole AR, Shimizu R, Rodwin AH, Jenefsky N, Davis M, Gilmer T. Outcomes of a Metaintervention to Improve Treatment Engagement Among Young Adults With Serious Mental Illnesses: Application of a Pilot Randomized Explanatory Design. J Adolesc Health. 2021 Nov;69(5):790-796. doi: 10.1016/j.jadohealth.2021.04.023. Epub 2021 Jun 4.

  • Munson MR, Jaccard JJ, Scott LD Jr, Narendorf SC, Moore KL, Jenefsky N, Cole A, Davis M, Gilmer T, Shimizu R, Pleines K, Cooper K, Rodwin AH, Hylek L, Amaro A. Engagement intervention versus treatment as usual for young adults with serious mental illness: a randomized pilot trial. Pilot Feasibility Stud. 2020 Jul 23;6:107. doi: 10.1186/s40814-020-00650-w. eCollection 2020.

MeSH Terms

Conditions

DepressionBipolar DisorderPsychotic DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Michelle R Munson, PhD

    New York University

    PRINCIPAL INVESTIGATOR
  • James Jaccard, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 4, 2018

First Posted

February 6, 2018

Study Start

January 31, 2018

Primary Completion

March 7, 2020

Study Completion

March 7, 2020

Last Updated

November 3, 2022

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations