CAMPUS - Feasibility Sub-Study

Study Overview
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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.

Detailed Description
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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.

Official Title
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Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: TAU - Phase 1
* Behavioral: CAMS - Phase 1
* Behavioral: DBT - Phase 1 and 2
* Behavioral: CAMS - Phase 2
* Behavioral: DBT - Phase 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled at the university; 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). 18 to 25 years of age; 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 Agree to video recording of all therapy and assessment sessions. Exclusion Criteria: 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); Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions); Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAMS to Maintenance<br>Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. | Behavioral: CAMS - Phase 1<br>* 4-8 weeks of CAMS treatment<br>|
| Experimental: CAMS to CAMS<br>Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. | Behavioral: CAMS - Phase 1<br>* 4-8 weeks of CAMS treatment<br>Behavioral: CAMS - Phase 2<br>* Up to 8 weeks of CAMS treatment<br>|
| Experimental: CAMS to DBT<br>Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. | Behavioral: CAMS - Phase 1<br>* 4-8 weeks of CAMS treatment<br>Behavioral: DBT - Phase 2<br>* Up to 8 weeks of DBT treatment<br>|
| Experimental: TAU to Maintenance<br>Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. | Behavioral: TAU - Phase 1<br>* 4-8 weeks of TAU treatment<br>|
| Experimental: TAU to CAMS<br>Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. | Behavioral: TAU - Phase 1<br>* 4-8 weeks of TAU treatment<br>Behavioral: CAMS - Phase 2<br>* Up to 8 weeks of CAMS treatment<br>|
| Experimental: TAU to DBT<br>Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. | Behavioral: TAU - Phase 1<br>* 4-8 weeks of TAU treatment<br>Behavioral: DBT - Phase 2<br>* Up to 8 weeks of DBT treatment<br>|
| Experimental: DBT Only<br>Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. | Behavioral: DBT - Phase 1 and 2<br>* up to 16 weeks of DBT treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Students who agree to randomization | Among students who are eligible to participate in the study and approached about the study by an intake worker, the percentage who agree to randomization to one of three treatments will be calculated. | To the end of initial Randomization (up to 1 week) | 
| Counselor Recruitment | Among the counselors eligible to participate in the study, three counselors from each site will agree to participate. | To the end of initial counselor recruitment (up to 2 weeks) | 
| Treatment Adherence | Existing gold-standard adherence instruments for CAMS and DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. | To the end of treatment period (up to 16 weeks) | 
| Attendance | The mean / median (depending on the distribution) number of sessions attended by students in each treatment condition, as well as the associated 95% confidence intervals, will be calculated. | To the end of treatment period (up to 16 weeks) | 
| Attrition | The mean / median (depending on the distribution) proportion of sessions attended by students in each treatment condition, as well as the associated 95% confidence intervals, will be calculated. | To the end of treatment period (up to 16 weeks) | 
| Student Treatment Satisfaction | An overall mean treatment satisfaction rating, and associated 95% confidence interval, will be calculated for each treatment condition based on students' responses on the Client Satisfaction Questionnaire (CSQ). | To the end of treatment period (up to 16 weeks) | 
| Counselor Training Satisfaction | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS and DBT online trainings. | To end of initial training period (up to 4 weeks) | 
| Counselor Study Satisfaction | An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). | To the end of study (up to 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), University Students