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

Sponsor

New York University (Other)

Overall Status

Completed

CT.gov ID

NCT02696109

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Stress Disorders, Post-traumatic Bipolar Disorder	Behavioral: Treatment As Usual Behavioral: Cornerstone	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multimodal psychosocial interventionMultimodal psychosocial intervention

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cornerstone 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 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.
Active Comparator: Treatment as Usual 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 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.

Arm

Intervention/Treatment

Experimental: Cornerstone

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

Active Comparator: Treatment as Usual

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

Outcome Measures

Primary Outcome Measures

Intention to Engage in Mental Health Services [Assessed at baseline]
Standardized scale developed and tested by Fishbein and colleagues
Intention to Engage in Mental Health Services [Assessed one year after baseline]
Standardized scale developed and tested by Fishbein and colleagues
Adherence to Medication [Assessed at baseline]
"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.
Treatment Continuation (or Dropout) [Assessed one year after baseline]
"Has the participant remained in services (or dropped out)?"

Secondary Outcome Measures

Mental Health Recovery [Assessed at baseline]
Recovery Scale Short Form
Mental Health Recovery [Assessed one year after baseline]
Recovery Scale Short Form
Depression Symptoms [Assessed at baseline]
Center for Epidemiological Studies Depression Scale
Depression Symptoms [Assessed one year after baseline]
Center for Epidemiological Studies Depression Scale
Young Adult Employment and Education [Assessed at baseline]
Current employment and/or education
Young Adult Employment and Education [Assessed one year after baseline]
Current employment and/or education

Other Outcome Measures

Cornerstone and Treatment as Usual Fidelity [Twice per group for one year]
6 items per session using Likert scale
Implementation Checklist [Bimonthly for one year]
Group facilitators will be asked questions related to implementation of the intervention, for example, barriers to young adult participation including time, transportation, staffing, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,