- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696109
Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial
Cornerstone Program for Transition-Age Youth With Serious Mental Illness: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- New York University Silver School of Social Work
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intention to Engage in Mental Health Services
Time Frame: Assessed at baseline
|
Standardized scale developed and tested by Fishbein and colleagues
|
Assessed at baseline
|
Intention to Engage in Mental Health Services
Time Frame: Assessed one year after baseline
|
Standardized scale developed and tested by Fishbein and colleagues
|
Assessed one year after baseline
|
Adherence to Medication
Time Frame: 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.
|
Assessed at baseline
|
Treatment Continuation (or Dropout)
Time Frame: Assessed one year after baseline
|
"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
Time Frame: Assessed at baseline
|
Recovery Scale Short Form
|
Assessed at baseline
|
Mental Health Recovery
Time Frame: Assessed one year after baseline
|
Recovery Scale Short Form
|
Assessed one year after baseline
|
Depression Symptoms
Time Frame: Assessed at baseline
|
Center for Epidemiological Studies Depression Scale
|
Assessed at baseline
|
Depression Symptoms
Time Frame: Assessed one year after baseline
|
Center for Epidemiological Studies Depression Scale
|
Assessed one year after baseline
|
Young Adult Employment and Education
Time Frame: Assessed at baseline
|
Current employment and/or education
|
Assessed at baseline
|
Young Adult Employment and Education
Time Frame: Assessed one year after baseline
|
Current employment and/or education
|
Assessed one year after baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cornerstone and Treatment as Usual Fidelity
Time Frame: Twice per group for one year
|
6 items per session using Likert scale
|
Twice per group for one year
|
Implementation Checklist
Time Frame: 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.
|
Bimonthly for one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34-MH102525-01A1MRM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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