CAMPUS - Feasibility Sub-Study

NCT ID: NCT04728815

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-10-15

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

We will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. Eighty-Five participants (N=85) from four CCCs will be randomized to one of three treatments delivered via a hybrid model: (1) a suicide-focused treatment - Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks (n=35); (2) Treatment as Usual (TAU) for 4-8 weeks (n=15); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=35), which includes individual therapy, skills training, phone/text coaching for the clients, and peer consultation for the counselors.

Sufficient responders to CAMS or TAU will discontinue services/be stepped down after 4-8 weeks. Non-responders to CAMS or TAU will be re-randomized to one of two higher intensity/dosage intervention options for an additional 8 weeks of treatment: (1) CAMS (either continued or administered for the first time) or (2) Comprehensive DBT.

For the feasibility study, we will also enroll 12 CCC counselors (3 per site) who will serve as study counselor participants and periodically complete measures focused on the experience of counselors working with suicidal college students.

Conditions

Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CAMS to Maintenance

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

Group Type: EXPERIMENTAL

CAMS - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of CAMS treatment

CAMS to CAMS

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

Group Type: EXPERIMENTAL

CAMS - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of CAMS treatment

CAMS - Phase 2

Intervention Type: BEHAVIORAL

Up to 8 weeks of CAMS treatment

CAMS to DBT

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

Group Type: EXPERIMENTAL

CAMS - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of CAMS treatment

DBT - Phase 2

Intervention Type: BEHAVIORAL

Up to 8 weeks of DBT treatment

TAU to Maintenance

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

Group Type: EXPERIMENTAL

TAU - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of TAU treatment

TAU to CAMS

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

Group Type: EXPERIMENTAL

TAU - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of TAU treatment

CAMS - Phase 2

Intervention Type: BEHAVIORAL

Up to 8 weeks of CAMS treatment

TAU to DBT

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

Group Type: EXPERIMENTAL

TAU - Phase 1

Intervention Type: BEHAVIORAL

4-8 weeks of TAU treatment

DBT - Phase 2

Intervention Type: BEHAVIORAL

Up to 8 weeks of DBT treatment

DBT Only

Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.

Group Type: EXPERIMENTAL

DBT - Phase 1 and 2

Intervention Type: BEHAVIORAL

up to 16 weeks of DBT treatment

Study Counselors

Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TAU - Phase 1

4-8 weeks of TAU treatment

Intervention Type: BEHAVIORAL

CAMS - Phase 1

4-8 weeks of CAMS treatment

Intervention Type: BEHAVIORAL

DBT - Phase 1 and 2

up to 16 weeks of DBT treatment

Intervention Type: BEHAVIORAL

CAMS - Phase 2

Up to 8 weeks of CAMS treatment

Intervention Type: BEHAVIORAL

DBT - Phase 2

Up to 8 weeks of DBT treatment

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Enrolled at the university;

2. Eligible to receive counseling services either in person or remotely at the campus CCC (e.g., some students who are living in specific states may not be eligible for therapeutic services).

3. 18 to 25 years of age;

4. Moderate to severe SI over the last two weeks indicated by a score of greater than or equal to 2 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

5. 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 enrolled in their university 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

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

University of Nevada - Reno

Reno, Nevada, United States

Rutgers University

New Brunswick, New Jersey, United States

Duke University

Durham, North Carolina, United States

University of Oregon

Eugene, Oregon, United States

Countries

United States

References

Kassing F, Seeley JR, Rizvi SL, Compton SN, Sinclair J, Oshin LA, Blalock K, Jobes DA, Crumlish J, Stadelman S, Gozenman-Sapin F, Snyderman T, Ruork AK, Fry CM, Gallop RJ, Goodrich J, Pistorello J. Assessing the implementation of suicide-focused treatments delivered in hybrid telemental health format in a real-world setting. Psychother Res. 2025 Sep;35(7):1198-1212. doi: 10.1080/10503307.2024.2415104. Epub 2024 Oct 22.

Reference Type: DERIVED

PMID: 39439041 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00103346

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH116062

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH116052

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH116050

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH116061

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00104815

Identifier Type: -

Identifier Source: org_study_id