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Completed

NCT Number: NCT02696109

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

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.

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Key information

Age range

17 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Silver School of Social Work

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

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.

Cornerstone

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.

Primary outcomes

  1. Intention to Engage in Mental Health Services

    Time frame: Assessed at baseline

    Standardized scale developed and tested by Fishbein and colleagues

  2. Intention to Engage in Mental Health Services

    Time frame: Assessed one year after baseline

    Standardized scale developed and tested by Fishbein and colleagues

  3. 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.

  4. Treatment Continuation (or Dropout)

    Time frame: Assessed one year after baseline

    "Has the participant remained in services (or dropped out)?"

Secondary outcomes

  1. Mental Health Recovery

    Time frame: Assessed at baseline

    Recovery Scale Short Form

  2. Mental Health Recovery

    Time frame: Assessed one year after baseline

    Recovery Scale Short Form

  3. Depression Symptoms

    Time frame: Assessed at baseline

    Center for Epidemiological Studies Depression Scale

  4. Depression Symptoms

    Time frame: Assessed one year after baseline

    Center for Epidemiological Studies Depression Scale

  5. Young Adult Employment and Education

    Time frame: Assessed at baseline

    Current employment and/or education

  6. Young Adult Employment and Education

    Time frame: Assessed one year after baseline

    Current employment and/or education

Other outcomes

  1. Cornerstone and Treatment as Usual Fidelity

    Time frame: Twice per group for one year

    6 items per session using Likert scale

  2. 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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2016
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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