Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Treatment As Usual (TAU)
- Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
- Behavioral: Dialectical Behavior Therapy (DBT) - Phase 2
- Behavioral: Maintenance/Monitoring - Phase 2
- Behavioral: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Reno, Nevada, United States, 89557
- University of Nevada - Reno
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers University
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- University of Oregon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
|
Treatment As Usual
Other Names:
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
|
|
Experimental: 2
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
|
Treatment As Usual
Other Names:
Dialectical Behavior Therapy
|
|
Experimental: 3
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
|
Treatment As Usual
Other Names:
Maintenance/Monitoring
|
|
Experimental: 4
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
|
Dialectical Behavior Therapy
Collaborative Assessment and Management of Suicidality
Other Names:
|
|
Experimental: 5
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
|
Maintenance/Monitoring
Collaborative Assessment and Management of Suicidality
Other Names:
|
|
Experimental: 6
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 2
Collaborative Assessment and Management of Suicidality
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to the end of Phase 1 treatment (up to 6 weeks)
|
|
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.
|
Baseline to the end of Stage 2 treatment (up to 14 weeks)
|
|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
From baseline to the end of follow-up (up to 26 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Self-Injurious Behavior
- Behavior
- Suicide
- Health Care Quality, Access, and Evaluation
- Amino Acids, Peptides, and Proteins
- Proteins
- Investigative Techniques
- Epidemiologic Methods
- Biological Factors
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Carbohydrates
- Health Care Facilities Workforce and Services
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Membrane Proteins
- Glycoproteins
- Glycoconjugates
- Epidemiologic Study Characteristics
- Antigens
- Antigens, Surface
- Clinical Trials as Topic
- Clinical Studies as Topic
- Membrane Glycoproteins
- Therapeutics
- Maintenance
- Clinical Trials, Phase I as Topic
- Clinical Trials, Phase II as Topic
- Dialectical Behavior Therapy
- Cell Adhesion Molecules
Other Study ID Numbers
- Pro00103346 (Duke IRB)
- Pro00104815 (Other Identifier: Duke University IRB)
- R01MH116062 (U.S. NIH Grant/Contract)
- R01MH116052 (U.S. NIH Grant/Contract)
- R01MH116050 (U.S. NIH Grant/Contract)
- R01MH116061 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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