CAMPUS - Feasibility Sub-Study

NCT04728815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-02-29

Study results available
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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.

Conditions

  • Suicide

Interventions

BEHAVIORAL

TAU - Phase 1

4-8 weeks of TAU treatment

BEHAVIORAL

CAMS - Phase 1

4-8 weeks of CAMS treatment

BEHAVIORAL

DBT - Phase 1 and 2

up to 16 weeks of DBT treatment

BEHAVIORAL

CAMS - Phase 2

Up to 8 weeks of CAMS treatment

BEHAVIORAL

DBT - Phase 2

Up to 8 weeks of DBT treatment

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Scott Compton, PhD · Duke University

  • Jacqueline Pistorello, PhD · University of Nevada at Reno (UNR)

  • Shireen Rizvi, PhD · Rutgers University

  • John Seeley, PhD · University of Oregon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-10-15
Completion
2022-10-15

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728815 on ClinicalTrials.gov