Clinical trial NCT04728815: CAMPUS - Feasibility Sub-Study
Official title: Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Dialectical Behavior Therapy (DBT)
Collaborative Assessment and Management of Suicide (CAMS)
University Students
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-01-28
Enrollment: 84
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: Participants 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.

There is an 8th Arm/Group of Consented Study Counselors from each of the 4 sites.
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: 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.

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).

Primary outcomes:
measure: Number of Eligible Students Who Agree to Randomization
timeFrame: To the end of initial Randomization (up to 1 week)
measure: Counselor Recruitment
timeFrame: To the end of initial counselor recruitment (up to 2 weeks)
measure: Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale
timeFrame: To the end of treatment period (up to 16 weeks)
measure: Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale
timeFrame: To the end of treatment period (up to 16 weeks)
measure: Number of Sessions Attended by Students in Each Treatment Condition
timeFrame: To the end of treatment period (up to 16 weeks)
measure: Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial)
timeFrame: To the end of treatment period (up to 16 weeks)
measure: Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: To the end of treatment period (up to 16 weeks)
measure: Counselor Training Satisfaction
timeFrame: To end of initial training period (up to 4 weeks)
measure: Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: To the end of stage 1 (up to 8 weeks)
measure: Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
timeFrame: Beginning to end of Stage 2 (up to 8 weeks)
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: