Comprehensive Adaptive Multisite Prevention of University Student Suicide
CAMPUS
6 other identifiers
interventional
253
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2021
CompletedFirst Posted
Study publicly available on registry
January 13, 2021
CompletedStudy Start
First participant enrolled
October 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2024
CompletedResults Posted
Study results publicly available
August 19, 2026
CompletedAugust 19, 2026
July 1, 2026
2.1 years
January 11, 2021
November 4, 2025
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Suicide Ideation - Phase 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.
Baseline to the end of Phase 1 treatment (up to 6 weeks)
Suicide Ideation - Phase 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.
Baseline to the end of Stage 2 treatment (up to 14 weeks)
Suicide Ideation - Follow-up (Week 26)
Change in score of Scale for Suicidal Ideation (SSI). This is a 19 question measure, each item rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Baseline to the end of follow-up (up to 26 weeks)
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
From baseline to the end of Phase 1 (up to 6 weeks)
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
From baseline to the end of Phase 2 (up to 14 weeks)
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
From baseline to the end of follow-up (up to 26 weeks)
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
From baseline to the end of Phase 1 (up to 6 weeks)
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
From baseline to the end of Phase 2 (up to 14 weeks)
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
From baseline to the end of follow-up (up to 26 weeks)
Study Arms (6)
1
EXPERIMENTALSubject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
2
EXPERIMENTALSubject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
3
EXPERIMENTALSubject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
4
EXPERIMENTALSubject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
5
EXPERIMENTALSubject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
6
EXPERIMENTALSubject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Interventions
Collaborative Assessment and Management of Suicidality
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
Eligibility Criteria
You may qualify if:
- Enrolled at the university;
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (4)
University of Nevada - Reno
Reno, Nevada, 89557, United States
Rutgers University
New Brunswick, New Jersey, 08901, United States
Duke University
Durham, North Carolina, 27705, United States
University of Oregon
Eugene, Oregon, 97403, United States
Related Publications (1)
Blalock K, Pistorello J, Rizvi SL, Seeley JR, Kassing F, Sinclair J, Oshin LA, Gallop RJ, Fry CM, Snyderman T, Jobes DA, Crumlish J, Krall HR, Stadelman S, Gozenman-Sapin F, Davies K, Steele D, Goldston DB, Compton SN. The Comprehensive Adaptive Multisite Prevention of University Student Suicide Trial: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 22;14:e68441. doi: 10.2196/68441.
PMID: 40262131DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Goldston, Ph.D.
- Organization
- Duke University
Study Officials
- PRINCIPAL INVESTIGATOR
Scott Compton, PhD
Duke University
- PRINCIPAL INVESTIGATOR
Jacqueline Pistorello, PhD
University of Nevada at Reno (UNR)
- PRINCIPAL INVESTIGATOR
Shireen Rizvi, PhD
Rutgers University
- PRINCIPAL INVESTIGATOR
John Seeley, PhD
University of Oregon
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2021
First Posted
January 13, 2021
Study Start
October 25, 2022
Primary Completion
November 19, 2024
Study Completion
November 19, 2024
Last Updated
August 19, 2026
Results First Posted
August 19, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.