DepressionNCT02696109
Cornerstone Program for Transition-Age Youth Study Protocol for a Randomized Controlled Trial
A study testing Treatment As Usual and Cornerstone in people with Depression and Stress Disorders, Post-traumatic, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress Disorders, Post-traumatic, Bipolar Disorder
- What is being tested?
- Treatment As Usual and Cornerstone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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,
Who cannot join
- Does not speak English
- Documented IQ lower than 70
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Silver School of Social Work
New York, New York, 10003
About this study
Official title: Cornerstone Program for Transition-Age Youth With Serious Mental Illness: 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.
Read the 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.
- Being tested
- Treatment As Usual, Cornerstone
- Keywords
- Transition age youth, Mental health, Mental health services, Engagement
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic, Bipolar Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As UsualBehavioural
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.
CornerstoneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cornerstone | Experimental | 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. Receives: Behavioral: Cornerstone |
| Treatment as Usual | Active comparator | 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. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
Measured: Assessed at baseline
Intention to Engage in Mental Health Services
Standardized scale developed and tested by Fishbein and colleagues
Measured: 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.
Measured: Assessed at baseline
Treatment Continuation (or Dropout)
"Has the participant remained in services (or dropped out)?"
Measured: Assessed one year after baseline
Secondary outcomes (6)
Mental Health Recovery
Recovery Scale Short Form
Measured: Assessed at baseline
Mental Health Recovery
Recovery Scale Short Form
Measured: Assessed one year after baseline
Depression Symptoms
Center for Epidemiological Studies Depression Scale
Measured: Assessed at baseline
Depression Symptoms
Center for Epidemiological Studies Depression Scale
Measured: Assessed one year after baseline
Young Adult Employment and Education
Current employment and/or education
Measured: Assessed at baseline
Young Adult Employment and Education
Current employment and/or education
Measured: Assessed one year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multimodal psychosocial intervention
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696109
- Sponsor's protocol ID
- R34-MH102525-01A1MRM
- Other IDs
- R34MH102525-01A1
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2015
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36738385Munson 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.
PubMed 27825381
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cornerstone Program for Transition-Age Youth With Serious Mental Illness: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02696109
- Acronym / sponsor ID
- R34-MH102525-01A1MRM
- Keywords
- Transition age youth, Mental health, Mental health services, Engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multimodal psychosocial intervention
| Arm | Type | Receives |
|---|---|---|
| Cornerstone | Experimental | Behavioral: CornerstoneParticipants 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 comparator | Behavioral: Treatment As UsualParticipants 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. |
Who may qualify
- Ages
- 17 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (2 listed)
- Does not speak English
- Documented IQ lower than 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment As UsualParticipants 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. | Behavioural | Treatment as Usual |
| CornerstoneParticipants 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. | Behavioural | Cornerstone |
Primary outcome
Intention to Engage in Mental Health Services
Time frame: Assessed at baseline
Standardized scale developed and tested by Fishbein and colleagues
Intention to Engage in Mental Health Services
Time frame: Assessed one year after baseline
Standardized scale developed and tested by Fishbein and colleagues
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.
Treatment Continuation (or Dropout)
Time frame: Assessed one year after baseline
"Has the participant remained in services (or dropped out)?"
6 secondary outcomes
Mental Health Recovery
Time frame: Assessed at baseline
Mental Health Recovery
Time frame: Assessed one year after baseline
Depression Symptoms
Time frame: Assessed at baseline
Depression Symptoms
Time frame: Assessed one year after baseline
Young Adult Employment and Education
Time frame: Assessed at baseline
Young Adult Employment and Education
Time frame: Assessed one year after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 36738385Cole 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.
- Derived from this study: PubMed 27825381Munson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment As Usual and Cornerstone in people with Depression and Stress Disorders, Post-traumatic, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to Engage in Mental Health Services (time frame: Assessed at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696109, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.