Comprehensive Adaptive Multisite Prevention of University Student Suicide

Suicide Clinical Trial

— CAMPUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707066
• Other study ID #: Pro00103346
• Secondary ID: Pro00104815R01MH
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: Ted Snyderman, MSW
• Phone: 919-668-3911
• Email: ted.snyderman[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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).

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Treatment As Usual (TAU)
Treatment As Usual
• Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1
Collaborative Assessment and Management of Suicidality
• Dialectical Behavior Therapy (DBT) - Phase 2
Dialectical Behavior Therapy
• Maintenance/Monitoring - Phase 2
Maintenance/Monitoring
• Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Oregon	Eugene	Oregon
United States	Rutgers University	New Brunswick	New Jersey
United States	University of Nevada - Reno	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	Non-Suicidal Self Injury - Stage 1	Total Occurrences of Non-Suicidal Self Injury	To the end of Stage 1 treatment (up to 8 weeks)
Primary	Non-Suicidal Self Injury - Stage 2	Total Occurrences of Non-Suicidal Self Injury	To the end of Stage 2 treatment (up to 20 weeks)
Primary	Non-Suicidal Self Injury - 6 month follow-up	Total Occurrences of Non-Suicidal Self Injury	To 6 month follow-up
Primary	Suicide Attempts - Stage 1	Total Occurrences of Suicide Attempts	To the end of Stage 1 treatment (up to 8 weeks)
Primary	Suicide Attempts - Stage 2	Total Occurrences of Suicide Attempts	To the end of Stage 2 treatment (up to 20 weeks)
Primary	Suicide Attempts - 6 month follow-up	Total Occurrences of Suicide Attempts	To 6 month follow-up