Just Do You Program for Young Adults With Serious Mental IIlness
Primary Purpose
Depression, Bipolar Disorder, Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Just Do You
Active Control
Sponsored by
About this trial
This is an interventional other trial for Depression
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).
Sites / Locations
- Mt Eden Personalized Recovery Oriented Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Active Comparator
Arm Label
Experimental Condition
Treatment as Usual Condition
Active Control Condition
Arm Description
Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere.
Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention.
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.
Outcomes
Primary Outcome Measures
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Secondary Outcome Measures
Adherence to medication
Past week adherence to mental health-related medications
Adherence to medication
Past week adherence to mental health-related medications
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS 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.
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03423212
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
March 7, 2020 (Actual)
Study Completion Date
March 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar Disorder, Psychosis, Anxiety Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Condition
Arm Type
Experimental
Arm Description
Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere.
Arm Title
Treatment as Usual Condition
Arm Type
No Intervention
Arm Description
Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention.
Arm Title
Active Control Condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Just Do You
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence to PROS program
Description
Past week attendance to mental health appointments at PROS
Time Frame
Assessed 4 weeks following baseline
Title
Adherence to PROS program
Description
Past week attendance to mental health appointments at PROS
Time Frame
Assessed 3 months following baseline
Secondary Outcome Measure Information:
Title
Adherence to medication
Description
Past week adherence to mental health-related medications
Time Frame
Assessed 4 weeks following baseline
Title
Adherence to medication
Description
Past week adherence to mental health-related medications
Time Frame
Assessed 3 months following baseline
Title
Client Engagement in Child Protective Services Scale
Description
This scale is altered to measure young adult engagement in PROS 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.
Time Frame
Assessed 4 weeks following baseline
Title
Client Engagement in Child Protective Services Scale
Description
This scale is altered to measure young adult engagement in PROS 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.
Time Frame
Assessed 3 months following baseline
Other Pre-specified Outcome Measures:
Title
Center for Epidemiological Studies Depression Scale
Description
This is a standardized measure of depression. The range on the scale is 0 to 60. Scores will be summed. Higher scores indicated higher levels of depression.
Time Frame
Assessed 3 months following baseline
Title
Global Measure of Perceived Stress
Description
This is a standardized measure of recent stress. The range on the scale is 0 to 56. Scores will be summed. Higher scores indicated higher levels of stress.
Time Frame
Assessed 4 weeks following baseline
Title
Inventory of Attitudes Toward Seeking Mental Health Services
Description
The investigators will use the stigma subscale of the Inventory of Attitudes Toward Seeking Mental Health Services. The range of the measure is 0 to 48, with higher scores indicating higher levels of stigma. For this study the score will be summed.
Time Frame
Assessed 4 weeks following baseline
Title
Inventory of Attitudes Toward Seeking Mental Health Services
Description
The investigators will use the stigma subscale of the Inventory of Attitudes Toward Seeking Mental Health Services. The range of the measure is 0 to 48, with higher scores indicating higher levels of stigma. For this study the score will be summed.
Time Frame
Assessed 3 months following baseline
Title
Group-Based Medical Mistrust Scale
Description
Standardized measure of mistrust of mental health services. The range for the measure is 4 to 20. For this study the scores will be summed, with higher scores indicating more mistrust.
Time Frame
Assessed 4 weeks following baseline
Title
Group-Based Medical Mistrust Scale
Description
Standardized measure of mistrust of mental health services. The range for the measure is 4 to 20. For this study the scores will be summed, with higher scores indicating more mistrust.
Time Frame
Assessed 3 months following baseline
Title
The Hope Scale
Description
This is a standardized measure of hope. The scores will be summed. The range is 8 to 96, with higher scores indicating higher levels of hope.
Time Frame
Assessed 4 weeks following baseline
Title
The Hope Scale
Description
This is a standardized measure of hope. The scores will be summed. The range is 8 to 96, with higher scores indicating higher levels of hope.
Time Frame
Assessed 3 months following baseline
Title
Self-Efficacy/Advocacy
Description
Perceived Behavioral Control (4-items adapted from autonomy factor and 3-items from capacity factor). The scores will be summed. For the autonomy factor, the range is 4 to 16, with higher scores indicating more control and autonomy. For the capacity factor, the range is 3 to 12, with higher scores indicating less capacity.
Time Frame
Assessed 4 weeks following baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle R Munson, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Jaccard, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt Eden Personalized Recovery Oriented Services
City
New York
State/Province
New York
ZIP/Postal Code
10457
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34099390
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.
Results Reference
derived
PubMed Identifier
32714561
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.
Results Reference
derived
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Just Do You Program for Young Adults With Serious Mental IIlness
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