Skip to content

Comprehensive Adaptive Multisite Prevention of University Student Suicide

Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS): A Multisite Trial With Duke as a Site, and Duke as Single IRB of Record

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04707066
Acronym
CAMPUS
Enrollment
253
Registered
2021-01-13
Start date
2022-10-25
Completion date
2024-11-19
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide

Keywords

Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), Sequential, multiple assignment, randomized trials (SMART), University Students

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.

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.

Interventions

BEHAVIORALTreatment As Usual (TAU)

Treatment As Usual

BEHAVIORALCollaborative Assessment and Management of Suicidality (CAMS) - Phase 1

Collaborative Assessment and Management of Suicidality

BEHAVIORALDialectical Behavior Therapy (DBT) - Phase 2

Dialectical Behavior Therapy

BEHAVIORALMaintenance/Monitoring - Phase 2

Maintenance/Monitoring

BEHAVIORALCollaborative Assessment and Management of Suicidality (CAMS) - Phase 2

Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2

Sponsors

Duke University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Sequential, multiple assignment, randomized trials (SMART) design

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1. Enrolled at the university; 2. 18 to 25 years of age; 3. 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 4. Agree to video recording of all therapy and assessment sessions.

Exclusion criteria

1. 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); 2. Students being unable to remain on campus long enough to go through the minimum number of sessions for Stage 1 (4 sessions); 3. Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Design outcomes

Primary

MeasureTime frameDescription
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1From 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 2From 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.
Suicide Ideation - Phase 1Baseline 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 2Baseline 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)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 1From 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 2From 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-upFrom 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) - Follow-upFrom 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORScott Compton, PhD

Duke University

PRINCIPAL_INVESTIGATORJacqueline Pistorello, PhD

University of Nevada at Reno (UNR)

PRINCIPAL_INVESTIGATORShireen Rizvi, PhD

Rutgers University

PRINCIPAL_INVESTIGATORJohn Seeley, PhD

University of Oregon

Participant flow

Pre-assignment details

For each Arm/Group, Phase 1 refers to Baseline through Week 6 while Phase 2 refers to the end of Phase 1 up to Week 14.

Baseline characteristics

Characteristic
Age, Continuous20.04 years
STANDARD_DEVIATION 1.95
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
Race (NIH/OMB)
Asian
32 Participants
Race (NIH/OMB)
Black or African American
5 Participants
Race (NIH/OMB)
More than one race
31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
126 Participants
Region of Enrollment
United States
227 Participants
Sex/Gender, Customized
Sex/Gender
Female
32 Participants
Sex/Gender, Customized
Sex/Gender
Male
15 Participants
Sex/Gender, Customized
Sex/Gender
Unknown or Not Reported
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
0 / 1130 / 1140 / 470 / 400 / 660 / 740 / 0
other
Total, other adverse events
5 / 1137 / 1146 / 474 / 406 / 669 / 740 / 0
serious
Total, serious adverse events
4 / 1138 / 1145 / 478 / 404 / 6610 / 740 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026