Clinical trial NCT04707066: Comprehensive Adaptive Multisite Prevention of University Student Suicide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Dialectical Behavior Therapy (DBT)
Collaborative Assessment and Management of Suicide (CAMS)
Sequential, multiple assignment, randomized trials (SMART)
University Students
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-13
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential, multiple assignment, randomized trials (SMART) design
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Suicide Ideation - Stage 1
timeFrame: Baseline to the end of Stage 1 treatment (up to 8 weeks)
measure: Suicide Ideation - Stage 2
timeFrame: Baseline to the end of Stage 2 treatment (up to 20 weeks)
measure: Suicide Ideation - 6 month follow-up
timeFrame: Baseline to 6 month follow-up
measure: Non-Suicidal Self Injury - Stage 1
timeFrame: To the end of Stage 1 treatment (up to 8 weeks)
measure: Non-Suicidal Self Injury - Stage 2
timeFrame: To the end of Stage 2 treatment (up to 20 weeks)
measure: Non-Suicidal Self Injury - 6 month follow-up
timeFrame: To 6 month follow-up
measure: Suicide Attempts - Stage 1
timeFrame: To the end of Stage 1 treatment (up to 8 weeks)
measure: Suicide Attempts - Stage 2
timeFrame: To the end of Stage 2 treatment (up to 20 weeks)
measure: Suicide Attempts - 6 month follow-up
timeFrame: To 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada - Reno
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: Duke University
name: Scott Compton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada at Reno (UNR)
name: Jacqueline Pistorello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Shireen Rizvi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oregon
name: John Seeley, PhD
role: PRINCIPAL_INVESTIGATOR
References: