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

Primary Purpose

Depression, Stress Disorders, Post-traumatic, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment As Usual
Cornerstone
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Transition age youth, Mental health, Mental health services, Engagement

Eligibility Criteria

17 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Be between ages 17 and 18 at time of enrollment in the study,
  2. Diagnosed with a mental disorder, including those who are diagnosed with any other co-morbid disorders,

Exclusion Criteria:

  1. Does not speak English
  2. Documented IQ lower than 70

Sites / Locations

  • New York University Silver School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cornerstone

Treatment as Usual

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
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.
Treatment Continuation (or Dropout)
"Has the participant remained in services (or dropped out)?"

Secondary Outcome Measures

Mental Health Recovery
Recovery Scale Short Form
Mental Health Recovery
Recovery Scale Short Form
Depression Symptoms
Center for Epidemiological Studies Depression Scale
Depression Symptoms
Center for Epidemiological Studies Depression Scale
Young Adult Employment and Education
Current employment and/or education
Young Adult Employment and Education
Current employment and/or education

Full Information

First Posted
December 10, 2015
Last Updated
October 31, 2022
Sponsor
New York University
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1. Study Identification

Unique Protocol Identification Number
NCT02696109
Brief Title
Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial
Official Title
Cornerstone Program for Transition-Age Youth With Serious Mental Illness: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Stress Disorders, Post-traumatic, Bipolar Disorder
Keywords
Transition age youth, Mental health, Mental health services, Engagement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multimodal psychosocial intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cornerstone
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cornerstone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intention to Engage in Mental Health Services
Description
Standardized scale developed and tested by Fishbein and colleagues
Time Frame
Assessed at baseline
Title
Intention to Engage in Mental Health Services
Description
Standardized scale developed and tested by Fishbein and colleagues
Time Frame
Assessed one year after baseline
Title
Adherence to Medication
Description
"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.
Time Frame
Assessed at baseline
Title
Treatment Continuation (or Dropout)
Description
"Has the participant remained in services (or dropped out)?"
Time Frame
Assessed one year after baseline
Secondary Outcome Measure Information:
Title
Mental Health Recovery
Description
Recovery Scale Short Form
Time Frame
Assessed at baseline
Title
Mental Health Recovery
Description
Recovery Scale Short Form
Time Frame
Assessed one year after baseline
Title
Depression Symptoms
Description
Center for Epidemiological Studies Depression Scale
Time Frame
Assessed at baseline
Title
Depression Symptoms
Description
Center for Epidemiological Studies Depression Scale
Time Frame
Assessed one year after baseline
Title
Young Adult Employment and Education
Description
Current employment and/or education
Time Frame
Assessed at baseline
Title
Young Adult Employment and Education
Description
Current employment and/or education
Time Frame
Assessed one year after baseline
Other Pre-specified Outcome Measures:
Title
Cornerstone and Treatment as Usual Fidelity
Description
6 items per session using Likert scale
Time Frame
Twice per group for one year
Title
Implementation Checklist
Description
Group facilitators will be asked questions related to implementation of the intervention, for example, barriers to young adult participation including time, transportation, staffing, etc.
Time Frame
Bimonthly for one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
New York University Silver School of Social Work
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27825381
Citation
Munson MR, Cole A, Stanhope V, Marcus SC, McKay M, Jaccard J, Ben-David S. Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial. Trials. 2016 Nov 8;17(1):537. doi: 10.1186/s13063-016-1654-0.
Results Reference
derived

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

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