Comprehensive Adaptive Multisite Prevention of University Student Suicide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2024-11-19

Brief Summary

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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.

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Detailed Description

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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

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential, multiple assignment, randomized trials (SMART) design

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.

Group Type EXPERIMENTAL

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

Treatment As Usual

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

Intervention Type BEHAVIORAL

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

2

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.

Group Type EXPERIMENTAL

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

Treatment As Usual

Dialectical Behavior Therapy (DBT) - Phase 2

Intervention Type BEHAVIORAL

Dialectical Behavior Therapy

3

Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.

Group Type EXPERIMENTAL

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

Treatment As Usual

Maintenance/Monitoring - Phase 2

Intervention Type BEHAVIORAL

Maintenance/Monitoring

4

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Collaborative Assessment and Management of Suicidality

Dialectical Behavior Therapy (DBT) - Phase 2

Intervention Type BEHAVIORAL

Dialectical Behavior Therapy

5

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Collaborative Assessment and Management of Suicidality

Maintenance/Monitoring - Phase 2

Intervention Type BEHAVIORAL

Maintenance/Monitoring

6

Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Collaborative Assessment and Management of Suicidality

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

Intervention Type BEHAVIORAL

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

Interventions

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Treatment As Usual (TAU)

Treatment As Usual

Intervention Type BEHAVIORAL

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

Collaborative Assessment and Management of Suicidality

Intervention Type BEHAVIORAL

Dialectical Behavior Therapy (DBT) - Phase 2

Dialectical Behavior Therapy

Intervention Type BEHAVIORAL

Maintenance/Monitoring - Phase 2

Maintenance/Monitoring

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Other Intervention Names

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TAU - Phase 1 CAMS

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Compton, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jacqueline Pistorello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada at Reno (UNR)

Shireen Rizvi, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

John Seeley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

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University of Nevada - Reno

Reno, Nevada, United States

Site Status

Rutgers University

New Brunswick, New Jersey, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

University of Oregon

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 40262131 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document