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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04707066
- Acronym / sponsor ID
- CAMPUS / Pro00103346
- Conditions
- Suicide
- Keywords
- Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), Sequential, multiple assignment, randomized trials (SMART), University Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 19 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Sequential, multiple assignment, randomized trials (SMART) design
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Treatment As Usual (TAU), Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. |
| 2 | Experimental | Behavioral: Treatment As Usual (TAU), Behavioral: Dialectical Behavior Therapy (DBT) - Phase 2Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. |
| 3 | Experimental | Behavioral: Treatment As Usual (TAU), Behavioral: Maintenance/Monitoring - Phase 2Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. |
| 4 | Experimental | Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1, Behavioral: Dialectical Behavior Therapy (DBT) - Phase 2Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. |
| 5 | Experimental | Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1, Behavioral: Maintenance/Monitoring - Phase 2Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. |
| 6 | Experimental | Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1, Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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 Usual (TAU)Also: TAU - Phase 1Treatment As Usual | Behavioural | 1, 2, 3 |
| Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1Also: CAMSCollaborative Assessment and Management of Suicidality | Behavioural | 4, 5, 6 |
| Dialectical Behavior Therapy (DBT) - Phase 2Dialectical Behavior Therapy | Behavioural | 2, 4 |
| Maintenance/Monitoring - Phase 2Maintenance/Monitoring | Behavioural | 3, 5 |
| Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 | Behavioural | 1, 6 |
Primary outcome
Suicide Ideation - Phase 1
Time frame: Baseline to the end of Phase 1 treatment (up to 6 weeks)
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 - Phase 2
Time frame: Baseline to the end of Stage 2 treatment (up to 14 weeks)
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 - Follow-up (Week 26)
Time frame: Baseline to the end of follow-up (up to 26 weeks)
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.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
Time frame: From baseline to the end of Phase 1 (up to 6 weeks)
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.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
Time frame: From baseline to the end of Phase 2 (up to 14 weeks)
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.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
Time frame: From baseline to the end of follow-up (up to 26 weeks)
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.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
Time frame: From baseline to the end of Phase 1 (up to 6 weeks)
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.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
Time frame: From baseline to the end of Phase 2 (up to 14 weeks)
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.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
Time frame: From baseline to the end of follow-up (up to 26 weeks)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40262131Blalock 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.
- Individual participant dataSharing planned: 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.
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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.
Scott Compton, PhD principal investigator
Duke University
Jacqueline Pistorello, PhD principal investigator
University of Nevada at Reno (UNR)
Shireen Rizvi, PhD principal investigator
Rutgers University
4 sites 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 (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.
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 4 inclusion and 3 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Suicide Ideation - Phase 1 (time frame: Baseline to the end of Phase 1 treatment (up to 6 weeks)). The study lists 9 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 NCT04707066, which also lists 1 linked publication.
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 19 Aug 2026.