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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00104815 | Other Identifier | Duke University IRB | |
| R01MH116062 | U.S. NIH Grant/Contract | View source | |
| R01MH116052 | U.S. NIH Grant/Contract | View source | |
| R01MH116050 | U.S. NIH Grant/Contract | View source | |
| R01MH116061 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. |
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| 2 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. |
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| 3 | Experimental | Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. |
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| 4 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. |
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| 5 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment As Usual (TAU) | Behavioral | Treatment As Usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to the end of Stage 1 treatment (up to 8 weeks) |
| 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. | Baseline to the end of Stage 2 treatment (up to 20 weeks) |
| 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. | Baseline to 6 month follow-up |
| Non-Suicidal Self Injury - Stage 1 | Total Occurrences of Non-Suicidal Self Injury | To the end of Stage 1 treatment (up to 8 weeks) |
| Non-Suicidal Self Injury - Stage 2 | Total Occurrences of Non-Suicidal Self Injury | To the end of Stage 2 treatment (up to 20 weeks) |
| Non-Suicidal Self Injury - 6 month follow-up | Total Occurrences of Non-Suicidal Self Injury | To 6 month follow-up |
| Suicide Attempts - Stage 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada - Reno | Reno | Nevada | 89557 | United States | ||
| Rutgers University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40262131 | Derived | 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. |
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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.
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.
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.
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 4, 2025 | |
| Reset | Nov 14, 2025 | |
| Release | Feb 4, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2024 | Sep 5, 2024 |
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Sequential, multiple assignment, randomized trials (SMART) design
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|
| 6 | Experimental | Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. |
|
| Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 | Behavioral | Collaborative Assessment and Management of Suicidality |
|
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| Dialectical Behavior Therapy (DBT) - Phase 2 | Behavioral | Dialectical Behavior Therapy |
|
| Maintenance/Monitoring - Phase 2 | Behavioral | Maintenance/Monitoring |
|
| Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 | Behavioral | Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 |
|
Total Occurrences of Suicide Attempts
| To the end of Stage 1 treatment (up to 8 weeks) |
| Suicide Attempts - Stage 2 | Total Occurrences of Suicide Attempts | To the end of Stage 2 treatment (up to 20 weeks) |
| Suicide Attempts - 6 month follow-up | Total Occurrences of Suicide Attempts | To 6 month follow-up |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Oregon | Eugene | Oregon | 97403 | United States |
| Reset | Feb 27, 2026 |
| Release | Mar 16, 2026 |
| Reset | Apr 3, 2026 |
| Release | Apr 22, 2026 |
| Reset | May 14, 2026 |
| Release | Jun 8, 2026 |
| Reset | Jul 2, 2026 |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 4, 2025 | Nov 14, 2025 | |||
| Feb 4, 2026 | Feb 27, 2026 | |||
| Mar 16, 2026 | Apr 3, 2026 | |||
| Apr 22, 2026 | May 14, 2026 | |||
| Jun 8, 2026 | Jul 2, 2026 |
| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D015815 | Cell Adhesion Molecules |
| D017321 | Clinical Trials, Phase I as Topic |
| D000077252 | Dialectical Behavior Therapy |
| D017322 | Clinical Trials, Phase II as Topic |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D002986 | Clinical Trials as Topic |
| D000068456 | Clinical Studies as Topic |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D005159 | Health Care Facilities Workforce and Services |
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