ClinicalTrials.gov
ClinicalTrials.gov Menu

Just Do You Program for Young Adults With Serious Mental IIlness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03423212
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Munson, New York University

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.


Condition or disease Intervention/treatment Phase
Depression Bipolar Disorder Psychosis Anxiety Disorders Behavioral: Just Do You Behavioral: Active Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Just Do You Program for Young Adults With Serious Mental IIlness: A Randomized Controlled Trial
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Condition
Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere.
Behavioral: Just Do You
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.

No Intervention: Treatment as Usual Condition
Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention.
Active Comparator: Active Control Condition
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
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 Measures :
  1. Adherence to PROS program [ Time Frame: Baseline ]
    Past week attendance to mental health appointments at PROS

  2. Adherence to PROS program [ Time Frame: Assessed 2 weeks following baseline ]
    Past week attendance to mental health appointments at PROS

  3. Adherence to PROS program [ Time Frame: Assessed 4 weeks following baseline ]
    Past week attendance to mental health appointments at PROS

  4. Adherence to PROS program [ Time Frame: Assessed 3 months following baseline ]
    Past week attendance to mental health appointments at PROS


Secondary Outcome Measures :
  1. Adherence to medication [ Time Frame: Baseline ]
    Past week adherence to mental health-related medications

  2. Adherence to medication [ Time Frame: Assessed 2 weeks following baseline ]
    Past week adherence to mental health-related medications

  3. Adherence to medication [ Time Frame: Assessed 4 weeks following baseline ]
    Past week adherence to mental health-related medications

  4. Adherence to medication [ Time Frame: Assessed 3 months following baseline ]
    Past week adherence to mental health-related medications

  5. Just Do You group attendance [ Time Frame: Assessed once, 3 months after randomization ]
    Standardized attendance sheets

  6. Client Engagement in Child Protective Services Scale [ Time Frame: Baseline ]
    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.

  7. Client Engagement in Child Protective Services Scale [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  8. Client Engagement in Child Protective Services Scale [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  9. Client Engagement in Child Protective Services Scale [ Time Frame: Assessed 3 months following baseline ]
    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.


Other Outcome Measures:
  1. Center for Epidemiological Studies Depression Scale [ Time Frame: Baseline ]
    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.

  2. Center for Epidemiological Studies Depression Scale [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  3. Center for Epidemiological Studies Depression Scale [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  4. Center for Epidemiological Studies Depression Scale [ Time Frame: Assessed 3 months following baseline ]
    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.

  5. Global Measure of Perceived Stress [ Time Frame: Baseline ]
    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.

  6. Global Measure of Perceived Stress [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  7. Global Measure of Perceived Stress [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  8. Global Measure of Perceived Stress [ Time Frame: Assessed 3 months following baseline ]
    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.

  9. Young Adult Future Plans Open-Ended Question [ Time Frame: Baseline ]
    What are the participant's plans for the future with regards to employment? Education?

  10. Young Adult Future Plans Open-Ended Question [ Time Frame: Assessed 2 weeks following baseline ]
    What are the participant's plans for the future with regards to employment? Education?

  11. Young Adult Future Plans Open-Ended Question [ Time Frame: Assessed 4 weeks following baseline ]
    What are the participant's plans for the future with regards to employment? Education?

  12. Young Adult Future Plans Open-Ended Question [ Time Frame: Assessed 3 months following baseline ]
    What are the participant's plans for the future with regards to employment? Education?

  13. Inventory of Attitudes Toward Seeking Mental Health Services [ Time Frame: Baseline ]
    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.

  14. Inventory of Attitudes Toward Seeking Mental Health Services [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  15. Inventory of Attitudes Toward Seeking Mental Health Services [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  16. Inventory of Attitudes Toward Seeking Mental Health Services [ Time Frame: Assessed 3 months following baseline ]
    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.

  17. Group-Based Medical Mistrust Scale [ Time Frame: Baseline ]
    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.

  18. Group-Based Medical Mistrust Scale [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  19. Group-Based Medical Mistrust Scale [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  20. Group-Based Medical Mistrust Scale [ Time Frame: Assessed 3 months following baseline ]
    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.

  21. The Hope Scale [ Time Frame: Baseline ]
    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.

  22. The Hope Scale [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  23. The Hope Scale [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  24. The Hope Scale [ Time Frame: Assessed 3 months following baseline ]
    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.

  25. Self-Efficacy/Advocacy [ Time Frame: Baseline ]
    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.

  26. Self-Efficacy/Advocacy [ Time Frame: Assessed 2 weeks following baseline ]
    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.

  27. Self-Efficacy/Advocacy [ Time Frame: Assessed 4 weeks following baseline ]
    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.

  28. Self-Efficacy/Advocacy [ Time Frame: Assessed 3 months following baseline ]
    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.

  29. Social Norms [ Time Frame: Baseline ]
    Two scales created by the investigators to measure social norm perceptions around attending mental health treatment and taking mental health medications. Scores will be summed. Range for both measures is 0 to 42 with higher scores indicating more perceiving social support around treatment and medication.

  30. Social Norms [ Time Frame: Assessed 2 weeks following baseline ]
    Two scales created by the investigators to measure social norm perceptions around attending mental health treatment and taking mental health medications. Scores will be summed. Range for both measures is 0 to 42 with higher scores indicating more perceiving social support around treatment and medication.

  31. Social Norms [ Time Frame: Assessed 4 weeks following baseline ]
    Two scales created by the investigators to measure social norm perceptions around attending mental health treatment and taking mental health medications. Scores will be summed. Range for both measures is 0 to 42 with higher scores indicating more perceiving social support around treatment and medication.

  32. Social Norms [ Time Frame: Assessed 3 months following baseline ]
    Two scales created by the investigators to measure social norm perceptions around attending mental health treatment and taking mental health medications. Scores will be summed. Range for both measures is 0 to 42 with higher scores indicating more perceiving social support around treatment and medication.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423212


Contacts
Contact: Michelle R Munson, PhD 212.992.9731 michelle.munson@nyu.edu
Contact: Andrea R Cole, PhD 617.335.0480 arc483@nyu.edu

Locations
United States, New York
Mt Eden Personalized Recovery Oriented Services Recruiting
New York, New York, United States, 10457
Contact: Christina Mango    718-282-3425 ext 512397    michelle.munson@nyu.edu   
Sponsors and Collaborators
New York University
Investigators
Principal Investigator: Michelle R Munson, PhD New York University
Principal Investigator: James Jaccard, PhD New York University

Responsible Party: Michelle Munson, Associate Professor, New York University
ClinicalTrials.gov Identifier: NCT03423212     History of Changes
Other Study ID Numbers: R34MH111861-01 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Anxiety Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders