Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-28 @ 12:56 PM
Study NCT ID:
NCT04707066
Status:
COMPLETED
Last Update Posted:
2024-11-22
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Adaptive Multisite Prevention of University Student Suicide
Sponsor:
Duke University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMPUS
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Pro00104815 | OTHER | Duke University IRB | View | |
| R01MH116062 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01MH116052 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01MH116050 | NIH | None | https://reporter.nih.gov/quic… | View |
| R01MH116061 | NIH | None | https://reporter.nih.gov/quic… | View |