Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial

Study Overview
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Brief Summary
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The purpose of this study is exploring a theoretically guided intervention, Cornerstone, which provides system 'boundary-spanning' services, including therapeutic services and mentorship, to transition-age youth with mental disorders. Cornerstone is designed to improve mental health service engagement and outcomes. The study uses a mixed methods approach to refine Cornerstone, and a hybrid design examining feasibility, acceptability, and preliminary impact with a randomized trial, alongside implementation.

Detailed Description
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The goal of this RCT is to refine and examine the feasibility, acceptability and preliminary impact of a theoretically guided intervention that provides system 'boundary-spanning' services to improve mental health service use and outcomes for low-income, transition-age youth with mental disorders (TAYMD). Through the refinement and testing of this intervention, called Cornerstone, we aim to address mental health challenges as well as the practical obstacles, such as lack of education, housing, and employment, that impede successful transition to adulthood. Cornerstone addresses these challenges by providing a service delivery strategy that spans the transition from the child to the adult system. Cornerstone centers on addressing three pressing problems: (1) the discontinuation, or at best fragmentation, of mental health care for TAYMD, (2) the lack of evidence-based interventions for TAYMD, and (3) the reality that promising practices for TAYMD, many of which Cornerstone builds upon, have not been tested with a sample that moves from child to adult services. Cornerstone deals with these problems in innovative ways at a time of transformation in health care. First, Cornerstone provides a 'boundary spanning case manager' (BSCM) across the transition. That is, rather than extending the age of service provision in the child system, we prioritize collaboration with the adult system and practical assistance to assure that the transition to developmentally and clinically appropriate adult services and independent adulthood happen at age 18. Second, Cornerstone incorporates an innovative form of social support, namely a recovery role model mentor (RRM) who is a decade older than TAYMD. The RRM co-facilitates weekly groups and provides important information and mentoring (i.e., modeling, connection) for TAYMD. Third, the development of Cornerstone is aligned with policy and practice transformation, particularly Affordable Care Act and New York State Medicaid Redesign, prioritizing coordinated, evidence-informed care for TAYMD, expansion of the workforce, and an emphasis on achieving functional outcomes and wellness. The aims are 1) to develop and refine all manuals and protocols for Cornerstone, 2) to determine the feasibility, acceptability, and preliminary impact of 'Cornerstone' relative to treatment as usual (TAU) on mediating outcomes (e.g., stigma), service use, and improved mental health and functioning outcomes, and 3) to explore implementation of Cornerstone through individual and group interviews with key stakeholder partners on aspects of the transforming local, state and national service context (e.g., staffing, payment). As a multidisciplinary team of professionals on the local, state, and national level we are committed to bridging the science to service gap for youth transitioning to adulthood with mental health challenges. Using qualitative methods and an RCT, this study is the first to examine a true transition intervention. We believe mental health services research that focuses on the transition to adulthood with innovative service delivery strategies that span developmental silos will decrease the number of TAYMD with unmet mental health needs.

Official Title
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Cornerstone Program for Transition-Age Youth With Serious Mental Illness: Study Protocol for a Randomized Controlled Trial

Conditions
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Depression, Stress Disorders, Post-traumatic, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Treatment As Usual
* Behavioral: Cornerstone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between ages 17 and 18 at time of enrollment in the study, Diagnosed with a mental disorder, including those who are diagnosed with any other co-morbid disorders, Exclusion Criteria: Does not speak English Documented IQ lower than 70

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multimodal psychosocial intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cornerstone<br>Participants in the experimental arm will be assigned a Transition Facilitator, a clinician with whom the client will meet one-on-one, and will be asked to attend once-a-week groups with other transition age youth. The groups will focus on issues relevant to successful transition to independent adulthood including stress and anger management and healthy relationships. | Behavioral: Cornerstone<br>* Participants in the experimental arm will be assigned a Transition Facilitator, a clinician with whom the client will meet one-on-one, and will be asked to attend once-a-week groups with other transition age youth. The groups will focus on issues relevant to successful transition to independent adulthood including stress and anger management and healthy relationships.<br>|
| Active Comparator: Treatment as Usual<br>Participants in the TAU arm will be assigned to standard care at our partnering mental health agency. These clients are free to attend one-on-one counseling or any other services available at the clinic or elsewhere to address mental health challenges. | Behavioral: Treatment As Usual<br>* Participants in the TAU arm will be assigned to standard care at our partnering mental health agency. These clients are free to attend one-on-one counseling or any other services available at the clinic or elsewhere to address mental health challenges.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to Engage in Mental Health Services | Standardized scale developed and tested by Fishbein and colleagues | Assessed at baseline | 
| Intention to Engage in Mental Health Services | Standardized scale developed and tested by Fishbein and colleagues | Assessed one year after baseline | 
| Adherence to Medication | How often in the past week have you taken your medication? Response options are: 0 - never, 1 - rarely, 2 - sometimes, 3 - all of the time. | Assessed at baseline | 
| Treatment Continuation (or Dropout) | Has the participant remained in services (or dropped out)? | Assessed one year after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Recovery | Recovery Scale Short Form | Assessed at baseline | 
| Mental Health Recovery | Recovery Scale Short Form | Assessed one year after baseline | 
| Depression Symptoms | Center for Epidemiological Studies Depression Scale | Assessed at baseline | 
| Depression Symptoms | Center for Epidemiological Studies Depression Scale | Assessed one year after baseline | 
| Young Adult Employment and Education | Current employment and/or education | Assessed at baseline | 
| Young Adult Employment and Education | Current employment and/or education | Assessed one year after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition age youth, Mental health, Mental health services, Engagement