Comprehensive Adaptive Multisite Prevention of University Student Suicide

Last updated: November 20, 2024
Sponsor: Duke University
Overall Status: Completed

Phase

N/A

Condition

Suicide

Treatment

Maintenance/Monitoring - Phase 2

Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2

Dialectical Behavior Therapy (DBT) - Phase 2

Clinical Study ID

NCT04707066
Pro00103346
R01MH116061
R01MH116062
Pro00104815
R01MH116052
R01MH116050
  • Ages 18-25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Enrolled at the university;

  2. 18 to 25 years of age;

  3. Moderate to severe SI over the last two weeks indicated by a score of ³2 on theCounseling Center Assessment of Psychological Symptoms (CCAPS-34) question, "I havethoughts of ending my life" (range is 0 "not at all like me" to 4 "extremely likeme"); and

  4. Agree to video recording of all therapy and assessment sessions.

Exclusion

Exclusion Criteria:

  1. Students who are deemed clinically inappropriate to receive services at the CCC byan intake counselor because of imminent risk, severe psychosis, or inability toremain enrolled in school (e.g., academic failure);

  2. Students being unable to remain on campus long enough to go through the minimumnumber 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).

Study Design

Total Participants: 227
Treatment Group(s): 5
Primary Treatment: Maintenance/Monitoring - Phase 2
Phase:
Study Start date:
October 25, 2022
Estimated Completion Date:
November 19, 2024

Study 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.

Connect with a study center

  • University of Nevada - Reno

    Reno, Nevada 89557
    United States

    Site Not Available

  • Rutgers University

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • University of Oregon

    Eugene, Oregon 97403
    United States

    Site Not Available

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