Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS): A Multisite Trial With Duke as a Site, and Duke as Single IRB of Record
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 8
- 主要终点
- Suicide Ideation - Stage 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled at the university;
- •18 to 25 years of age;
- •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
- •Agree to video recording of all therapy and assessment sessions.
排除标准
- •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 on campus 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).
研究组 & 干预措施
1
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
干预措施: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 (Behavioral)
2
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
干预措施: Dialectical Behavior Therapy (DBT) - Phase 2 (Behavioral)
6
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
干预措施: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 (Behavioral)
6
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
干预措施: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2 (Behavioral)
2
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
干预措施: Treatment As Usual (TAU) (Behavioral)
3
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
干预措施: Treatment As Usual (TAU) (Behavioral)
3
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
干预措施: Maintenance/Monitoring - Phase 2 (Behavioral)
4
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
干预措施: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 (Behavioral)
4
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
干预措施: Dialectical Behavior Therapy (DBT) - Phase 2 (Behavioral)
5
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
干预措施: Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1 (Behavioral)
5
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
干预措施: Maintenance/Monitoring - Phase 2 (Behavioral)
1
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
干预措施: Treatment As Usual (TAU) (Behavioral)
结局指标
主要结局
Suicide Ideation - Stage 2
时间窗: Baseline to the end of Stage 2 treatment (up to 20 weeks)
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.
Suicide Ideation - 6 month follow-up
时间窗: Baseline to 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.
Suicide Attempts - Stage 1
时间窗: To the end of Stage 1 treatment (up to 8 weeks)
Total Occurrences of Suicide Attempts
Suicide Attempts - Stage 2
时间窗: To the end of Stage 2 treatment (up to 20 weeks)
Total Occurrences of Suicide Attempts
Non-Suicidal Self Injury - Stage 1
时间窗: To the end of Stage 1 treatment (up to 8 weeks)
Total Occurrences of Non-Suicidal Self Injury
Suicide Ideation - Stage 1
时间窗: Baseline to the end of Stage 1 treatment (up to 8 weeks)
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.
Suicide Attempts - 6 month follow-up
时间窗: To 6 month follow-up
Total Occurrences of Suicide Attempts
Non-Suicidal Self Injury - 6 month follow-up
时间窗: To 6 month follow-up
Total Occurrences of Non-Suicidal Self Injury
Non-Suicidal Self Injury - Stage 2
时间窗: To the end of Stage 2 treatment (up to 20 weeks)
Total Occurrences of Non-Suicidal Self Injury
Suicide Ideation - Phase 1
时间窗: Baseline to the end of Phase 1 treatment (up to 6 weeks)
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.
Suicide Ideation - Phase 2
时间窗: Baseline to the end of Stage 2 treatment (up to 14 weeks)
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.
Suicide Ideation - Follow-up (Week 26)
时间窗: Baseline to the end of follow-up (up to 26 weeks)
Change in score of Scale for Suicidal Ideation (SSI). This is a 19 question measure, each item rated from 0-2. Total score is from 0-38, with a higher score indicating greater suicidality concern.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
时间窗: From baseline to the end of Phase 1 (up to 6 weeks)
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
时间窗: From baseline to the end of Phase 2 (up to 14 weeks)
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Total Occurrences of Self-Reported Non-Suicidal Self Injury (NSSI) on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
时间窗: From baseline to the end of follow-up (up to 26 weeks)
Count is based on SITBI NSSI section, item 15 "How many episodes since the last assessment have you hurt yourself without wanting to die?" completed by the independent evaluators.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 1
时间窗: From baseline to the end of Phase 1 (up to 6 weeks)
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Phase 2
时间窗: From baseline to the end of Phase 2 (up to 14 weeks)
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
Total Occurrences of Suicide Attempt on the Self-Injurious Thoughts and Behaviors Interview (SITBI) - Follow-up
时间窗: From baseline to the end of follow-up (up to 26 weeks)
Count is based on SITBI suicide attempt section, items 1 and 6. Item 6 asks "Since the last assessment, have you tried to kill yourself? In other words, have you purposefully hurt yourself with some intent to die?" If they answered yes, then item 6 is asked "How many suicide attempts have you made since the last assessment?" by the independent evaluators.
次要结局
未报告次要终点