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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696109
Enrollment
59
Registered
2016-03-02
Start date
2016-02-29
Completion date
2018-11-30
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression, Stress Disorders, Post-traumatic

Keywords

Transition age youth, Mental health, Mental health services, Engagement

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.

Interventions

BEHAVIORALTreatment 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.

BEHAVIORALCornerstone

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.

Sponsors

New York University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Multimodal psychosocial intervention

Eligibility

Sex/Gender
ALL
Age
17 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Continuation (or Dropout)Assessed one year after baselineHas the participant remained in services (or dropped out)?
Adherence to MedicationAssessed at baselineHow often in the past week have you taken your medication? Response options are: 0 - never, 1 - rarely, 2 - sometimes, 3 - all of the time.
Intention to Engage in Mental Health ServicesAssessed at baselineStandardized scale developed and tested by Fishbein and colleagues

Secondary

MeasureTime frameDescription
Young Adult Employment and EducationAssessed at baselineCurrent employment and/or education
Mental Health RecoveryAssessed at baselineRecovery Scale Short Form
Depression SymptomsAssessed at baselineCenter for Epidemiological Studies Depression Scale

Other

MeasureTime frameDescription
Cornerstone and Treatment as Usual FidelityTwice per group for one year6 items per session using Likert scale
Implementation ChecklistBimonthly for one yearGroup facilitators will be asked questions related to implementation of the intervention, for example, barriers to young adult participation including time, transportation, staffing, etc.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026