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Trials / Completed

CompletedNCT04728815

CAMPUS - Feasibility Sub-Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
84 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
18 Years – 25 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTAU - Phase 14-8 weeks of TAU treatment
BEHAVIORALCAMS - Phase 14-8 weeks of CAMS treatment
BEHAVIORALDBT - Phase 1 and 2up to 16 weeks of DBT treatment
BEHAVIORALCAMS - Phase 2Up to 8 weeks of CAMS treatment
BEHAVIORALDBT - Phase 2Up to 8 weeks of DBT treatment

Timeline

Start date
2021-01-04
Primary completion
2022-10-15
Completion
2022-10-15
First posted
2021-01-28
Last updated
2024-02-29
Results posted
2024-02-29

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04728815. Inclusion in this directory is not an endorsement.