Just Do You Program for Young Adults With Serious Mental IIlness

Depression Clinical Trial

Official title:

Just Do You Program for Young Adults With Serious Mental IIlness: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03423212
• Other study ID #: R34MH111861-01
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: March 7, 2020

Study information

• Verified date: September 2020
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 7, 2020
• Est. primary completion date: March 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Depression
• Disease
• Psychosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mt Eden Personalized Recovery Oriented Services	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Center for Epidemiological Studies Depression Scale	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.	Assessed 3 months following baseline
Other	Global Measure of Perceived Stress	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.	Assessed 4 weeks following baseline
Other	Inventory of Attitudes Toward Seeking Mental Health Services	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.	Assessed 4 weeks following baseline
Other	Inventory of Attitudes Toward Seeking Mental Health Services	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.	Assessed 3 months following baseline
Other	Group-Based Medical Mistrust Scale	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.	Assessed 4 weeks following baseline
Other	Group-Based Medical Mistrust Scale	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.	Assessed 3 months following baseline
Other	The Hope Scale	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.	Assessed 4 weeks following baseline
Other	The Hope Scale	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.	Assessed 3 months following baseline
Other	Self-Efficacy/Advocacy	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.	Assessed 4 weeks following baseline
Primary	Adherence to PROS program	Past week attendance to mental health appointments at PROS	Assessed 4 weeks following baseline
Primary	Adherence to PROS program	Past week attendance to mental health appointments at PROS	Assessed 3 months following baseline
Secondary	Adherence to medication	Past week adherence to mental health-related medications	Assessed 4 weeks following baseline
Secondary	Adherence to medication	Past week adherence to mental health-related medications	Assessed 3 months following baseline
Secondary	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.	Assessed 4 weeks following baseline
Secondary	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.	Assessed 3 months following baseline