Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial
2 other identifiers
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
Started Feb 2016
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedNovember 1, 2022
February 1, 2020
2.8 years
December 10, 2015
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
Assessed at baseline
Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
Assessed one year after baseline
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.
Assessed at baseline
Treatment Continuation (or Dropout)
"Has the participant remained in services (or dropped out)?"
Assessed one year after baseline
Secondary Outcomes (6)
Mental Health Recovery
Assessed at baseline
Mental Health Recovery
Assessed one year after baseline
Depression Symptoms
Assessed at baseline
Depression Symptoms
Assessed one year after baseline
Young Adult Employment and Education
Assessed at baseline
- +1 more secondary outcomes
Other Outcomes (2)
Cornerstone and Treatment as Usual Fidelity
Twice per group for one year
Implementation Checklist
Bimonthly for one year
Study Arms (2)
Cornerstone
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants 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
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 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.
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- Does not speak English
- Documented IQ lower than 70
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Silver School of Social Work
New York, New York, 10003, United States
Related Publications (2)
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.
PMID: 36738385DERIVEDMunson 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.
PMID: 27825381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2015
First Posted
March 2, 2016
Study Start
February 1, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
November 1, 2022
Record last verified: 2020-02