SuicideCAMPUSNCT04707066
Comprehensive Adaptive Multisite Prevention of University Student Suicide
A study testing Treatment As Usual (TAU), Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 and Dialectical Behavior Therapy (DBT) - Phase 2 in people with Suicide, run by Duke University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Suicide
- What is being tested?
- Treatment As Usual (TAU), Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 and Dialectical Behavior Therapy (DBT) - Phase 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Oct 2022to 19 Nov 2024
- Phase
- Interventional
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke University
Durham, North Carolina, 27705
University of Oregon
Eugene, Oregon, 97403
Rutgers University
New Brunswick, New Jersey, 08901
University of Nevada - Reno
Reno, Nevada, 89557
About this study
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
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.
Read the 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.
- Conditions
- Suicide
- Being tested
- 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
- Keywords
- Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), Sequential, multiple assignment, randomized trials (SMART), University Students
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment As Usual (TAU)Behavioural
Also called TAU - Phase 1
Treatment As Usual
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1Behavioural
Also called CAMS
Collaborative Assessment and Management of Suicidality
Dialectical Behavior Therapy (DBT) - Phase 2Behavioural
Dialectical Behavior Therapy
Maintenance/Monitoring - Phase 2Behavioural
Maintenance/Monitoring
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2Behavioural
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. Receives: Behavioral: Treatment As Usual (TAU); Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 |
| 2 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. Receives: Behavioral: Treatment As Usual (TAU); Behavioral: Dialectical Behavior Therapy (DBT) - Phase 2 |
| 3 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. Receives: Behavioral: Treatment As Usual (TAU); Behavioral: Maintenance/Monitoring - Phase 2 |
| 4 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. Receives: Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1; Behavioral: Dialectical Behavior Therapy (DBT) - Phase 2 |
| 5 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. Receives: Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1; Behavioral: Maintenance/Monitoring - Phase 2 |
| 6 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. Receives: Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1; Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of follow-up (up to 26 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start25 Oct 2022
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential, multiple assignment, randomized trials (SMART) design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Scott Compton, PhD, Principal investigator, Duke UniversityJacqueline Pistorello, PhD, Principal investigator, University of Nevada at Reno (UNR)Shireen Rizvi, PhD, Principal investigator, Rutgers UniversityJohn Seeley, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707066
- Sponsor's protocol ID
- Pro00103346
- Other IDs
- Pro00104815, R01MH116062, R01MH116052, R01MH116050, R01MH116061
- Acronym
- CAMPUS
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2021
- Last updated
- 19 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40262131