Clinical trial NCT03423212: Just Do You Program for Young Adults With Serious Mental IIlness
Official title: Just Do You Program for Young Adults With Serious Mental IIlness: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Bipolar Disorder
Psychosis
Anxiety Disorders
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Background

Young adults have elevated rates of serious mental illnesses and they often do not receive consistent mental health care. This is a considerable challenge for public health, as most often mental health conditions persist into adulthood. Continuing to engage this population in their professional mental health treatment has been a pervasive challenge globally. Few mental health interventions have been designed specifically for young adults and none are conceptualized as meta-interventions or orientation programs. 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).

Methods/design

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, the investigators 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.

Discussion

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. Continuity of care among this population is a serious challenge and Just Do You has the potential to address this challenge in the service system for poor, young adults living in low-resourced communities. If it is shown to be successful in this setting, it could likely be used to address the continuity of care issue more broadly in additional settings that serve young adults with serious mental illness. It may enhance the menu of care options for those who have been recently diagnosed with a serious mental health condition, providing them with an orientation for how professional mental health care can help them. The program is recovery-oriented, builds on the best evidence to date, and is in line with both local and national health care reform efforts.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Adherence to PROS program
timeFrame: Assessed 4 weeks following baseline
measure: Adherence to PROS program
timeFrame: Assessed 3 months following baseline
Secondary outcomes:
measure: Adherence to medication
timeFrame: Assessed 4 weeks following baseline
measure: Adherence to medication
timeFrame: Assessed 3 months following baseline
measure: Client Engagement in Child Protective Services Scale
timeFrame: Assessed 4 weeks following baseline
measure: Client Engagement in Child Protective Services Scale
timeFrame: Assessed 3 months following baseline
Other outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: Assessed 3 months following baseline
measure: Global Measure of Perceived Stress
timeFrame: Assessed 4 weeks following baseline
measure: Inventory of Attitudes Toward Seeking Mental Health Services
timeFrame: Assessed 4 weeks following baseline
measure: Inventory of Attitudes Toward Seeking Mental Health Services
timeFrame: Assessed 3 months following baseline
measure: Group-Based Medical Mistrust Scale
timeFrame: Assessed 4 weeks following baseline
measure: Group-Based Medical Mistrust Scale
timeFrame: Assessed 3 months following baseline
measure: The Hope Scale
timeFrame: Assessed 4 weeks following baseline
measure: The Hope Scale
timeFrame: Assessed 3 months following baseline
measure: Self-Efficacy/Advocacy
timeFrame: Assessed 4 weeks following baseline
Locations:
city: New York
country: United States
facility: Mt Eden Personalized Recovery Oriented Services
state: New York
Study officials:
affiliation: New York University
name: Michelle R Munson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: James Jaccard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.