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

NCT ID: NCT02696109

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-11-30

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.

Conditions

Depression; Stress Disorders, Post-traumatic; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cornerstone

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York University Silver School of Social Work

New York, New York, United States

Countries

United States

References

Cole AR, Adams DR, Ben-David S, Sapiro B, Villodas ML, Stanhope V, Jaccard J, Munson MR. Feasibility, Acceptability and Preliminary Implementation of the Cornerstone Program for Transition-Age Youth with Mental Health Conditions: A Mixed Methods Study. Adm Policy Ment Health. 2023 May;50(3):506-519. doi: 10.1007/s10488-023-01254-1. Epub 2023 Feb 4.

Reference Type: DERIVED

PMID: 36738385 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27825381 (View on PubMed)

Other Identifiers

R34MH102525-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R34-MH102525-01A1MRM

Identifier Type: -

Identifier Source: org_study_id