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Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS)

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment As Usual (TAU)
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Dialectical Behavior Therapy (DBT) - Phase 2
Maintenance/Monitoring - Phase 2
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), Sequential, multiple assignment, randomized trials (SMART), University Students

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Enrolled at the university;
  2. 18 to 25 years of age;
  3. Moderate to severe SI over the last two weeks indicated by a score of ³2 on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34) question, "I have thoughts of ending my life" (range is 0 "not at all like me" to 4 "extremely like me"); and
  4. Agree to video recording of all therapy and assessment sessions.

Exclusion Criteria:

  1. Students who are deemed clinically inappropriate to receive services at the CCC by an intake counselor because of imminent risk, severe psychosis, or inability to remain enrolled in school (e.g., academic failure);
  2. Students being unable to remain on campus long enough to go through the minimum number of sessions for Stage 1 (4 sessions);
  3. Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Sites / Locations

  • University of Nevada - RenoRecruiting
  • Rutgers UniversityRecruiting
  • Duke UniversityRecruiting
  • University of OregonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.

Outcomes

Primary Outcome Measures

Suicide Ideation - Stage 1
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Suicide Ideation - Stage 2
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Suicide Ideation - 6 month follow-up
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Non-Suicidal Self Injury - Stage 1
Total Occurrences of Non-Suicidal Self Injury
Non-Suicidal Self Injury - Stage 2
Total Occurrences of Non-Suicidal Self Injury
Non-Suicidal Self Injury - 6 month follow-up
Total Occurrences of Non-Suicidal Self Injury
Suicide Attempts - Stage 1
Total Occurrences of Suicide Attempts
Suicide Attempts - Stage 2
Total Occurrences of Suicide Attempts
Suicide Attempts - 6 month follow-up
Total Occurrences of Suicide Attempts

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
October 25, 2022
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04707066
Brief Title
Comprehensive Adaptive Multisite Prevention of University Student Suicide
Acronym
CAMPUS
Official Title
Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS): A Multisite Trial With Duke as a Site, and Duke as Single IRB of Record
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Suicide is the 2nd leading cause of death among college students and suicidal ideation and suicide-related behaviors are a frequent presenting problem at college counseling centers (CCCs), which are overburdened. Studies show that some students respond rapidly to treatment, whereas others require considerably more resources. Evidence-based adaptive treatment strategies (ATSs) are needed to address this heterogeneity in responsivity and complexity. ATSs individualize treatment via decision rules specifying how the type and intensity of an intervention can be sequenced based on risk factors, response, or compliance. The purpose of this multisite study is to investigate the effectiveness of four adaptive treatment strategies (ATSs) to treat college students who report suicidal ideation when first seeking services at their college counseling center This multisite study will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. This Sequential Multi-Assignment Randomized Trial (SMART) will have two stages of intervention. In Stage 1, 700 participants from four CCCs will be randomized to 4-8 weeks of: 1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) or 2) Treatment as Usual (TAU). Sufficient responders to either intervention will discontinue services/be stepped down. Non-responders will be re-randomized to one of two Stage 2 higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT), which includes individual therapy, skills group, and phone/text coaching for the clients and peer consultation for the counselors.
Detailed Description
This study will utilize a Sequential Multi-Assignment Randomized Trial (SMART) design. College students seeking counseling services through the College Counseling Centers (CCCs) will be recruited. In Stage 1, student participants will be initially randomized into either treatment as usual (TAU) or Collaborative Assessment and Management of Suicidality (CAMS). Student participants receiving TAU will receive the customary treatment they would receive at the CCC at a frequency typical to the site (e.g., once a week). Student participants receiving the CAMS intervention will receive CAMS through weekly sessions with a counselor that will last for 50-60 minutes. Responders to either CAMS or TAU may stop intervention after three consecutive weeks of non-engagement in suicidal acts combined with the ability to cope with suicidal ideation, if present, based on counselor's clinical global impression ratings of improvement and severity. Stage 1 has an intended duration of between 4 and 8 weeks. Non-responders to Stage 1 treatments, will be re-randomized to one of two Stage 2 treatments: CAMS or Dialectical Behavior Therapy (DBT). Student participants receiving DBT will engage in individual therapy and a skills training group. Stage 2 has an intended treatment duration between 4 and 16 weeks. All treatment in Stage 1 and Stage 2 (TAU, CAMS, and DBT) will usually be administered in person. Counselors will provide TAU, CAMS, and DBT to study participants. They will also participate in CAMS and DBT trainings and ongoing consultation teams for each. The project estimates 36 months (3 years) total duration from beginning of recruitment until final data collection. The duration of treatment will vary from 4 to 24 weeks and is based on response. Total participant duration in study, due to the assessments, is approximately 48 weeks (which includes the 24-week follow-up assessment). Counselor participants will participate for 1-3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), Sequential, multiple assignment, randomized trials (SMART), University Students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Sequential, multiple assignment, randomized trials (SMART) design
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Arm Title
2
Arm Type
Experimental
Arm Description
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Arm Title
3
Arm Type
Experimental
Arm Description
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Arm Title
4
Arm Type
Experimental
Arm Description
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Arm Title
5
Arm Type
Experimental
Arm Description
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Arm Title
6
Arm Type
Experimental
Arm Description
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Other Intervention Name(s)
TAU - Phase 1
Intervention Description
Treatment As Usual
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Other Intervention Name(s)
CAMS
Intervention Description
Collaborative Assessment and Management of Suicidality
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy (DBT) - Phase 2
Intervention Description
Dialectical Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Maintenance/Monitoring - Phase 2
Intervention Description
Maintenance/Monitoring
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
Intervention Description
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
Primary Outcome Measure Information:
Title
Suicide Ideation - Stage 1
Description
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Time Frame
Baseline to the end of Stage 1 treatment (up to 8 weeks)
Title
Suicide Ideation - Stage 2
Description
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Time Frame
Baseline to the end of Stage 2 treatment (up to 20 weeks)
Title
Suicide Ideation - 6 month follow-up
Description
Change in score of CAMS Scale for Suicidal Ideation (SSI). This is a 19 question measure, each rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Time Frame
Baseline to 6 month follow-up
Title
Non-Suicidal Self Injury - Stage 1
Description
Total Occurrences of Non-Suicidal Self Injury
Time Frame
To the end of Stage 1 treatment (up to 8 weeks)
Title
Non-Suicidal Self Injury - Stage 2
Description
Total Occurrences of Non-Suicidal Self Injury
Time Frame
To the end of Stage 2 treatment (up to 20 weeks)
Title
Non-Suicidal Self Injury - 6 month follow-up
Description
Total Occurrences of Non-Suicidal Self Injury
Time Frame
To 6 month follow-up
Title
Suicide Attempts - Stage 1
Description
Total Occurrences of Suicide Attempts
Time Frame
To the end of Stage 1 treatment (up to 8 weeks)
Title
Suicide Attempts - Stage 2
Description
Total Occurrences of Suicide Attempts
Time Frame
To the end of Stage 2 treatment (up to 20 weeks)
Title
Suicide Attempts - 6 month follow-up
Description
Total Occurrences of Suicide Attempts
Time Frame
To 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled at the university; 18 to 25 years of age; Moderate to severe SI over the last two weeks indicated by a score of ³2 on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34) question, "I have thoughts of ending my life" (range is 0 "not at all like me" to 4 "extremely like me"); and Agree to video recording of all therapy and assessment sessions. Exclusion Criteria: Students who are deemed clinically inappropriate to receive services at the CCC by an intake counselor because of imminent risk, severe psychosis, or inability to remain enrolled in school (e.g., academic failure); Students being unable to remain on campus long enough to go through the minimum number of sessions for Stage 1 (4 sessions); Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ted Snyderman, MSW
Phone
919-668-3911
Email
ted.snyderman@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kyla Blalock, PhD
Phone
919-684-4686
Email
kyla.blalock@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Compton, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacqueline Pistorello, PhD
Organizational Affiliation
University of Nevada at Reno (UNR)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shireen Rizvi, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Seeley, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nevada - Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Kassing, PhD
Email
fkassing@unr.edu
First Name & Middle Initial & Last Name & Degree
Jacque Pistorello, PhD
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Krall
Email
hk952@gsapp.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Shireen Rizvi, PhD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ted Snyderman, MSW
Email
ted.snyderman@duke.edu
First Name & Middle Initial & Last Name & Degree
Scott Compton, PhD
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Sinclair, PhD
Email
jamesin@uoregon.edu
First Name & Middle Initial & Last Name & Degree
John Seeley, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will participant de-identified data (linked only by GUID) with the National Institute of Mental Health Data Archive (NDA). The NDA is an informatics system and research data repository developed by the National Institutes of Health (NIH) to share research data. The NDA provides the infrastructure to store, search across, and analyze various types of data. In addition, The NDA provides longitudinal storage of a research participant's information generated by one or more research studies. In other words, the NDA is able to associate a single research participant's genomic, imaging, clinical assessment and other information even if the data were collected at different locations or through different studies. By doing so, the NDA gives researchers access to more data than they can collect on their own, making it easier and faster for researchers to gather, evaluate, and share research information from a variety of sources.
IPD Sharing Time Frame
All subject data will be submitted for inclusion in the NDA, through the conclusion of data collection activities. Data is to be submitted cumulatively, every 6 months.
IPD Sharing Access Criteria
The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.
IPD Sharing URL
https://nda.nih.gov/about/about-us.html

Learn more about this trial

Comprehensive Adaptive Multisite Prevention of University Student Suicide

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