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NCT04728815 · ClinicalTrials.gov registry record · NA

CAMPUS - Feasibility Sub-Study

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
84
Enrollment target

NCT04728815 is a NA study that has completed, run by Duke University. The registered enrollment target is 84 participants.

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The verdict

NCT04728815, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
84 participants
Enrollment target

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.

Interventions

  • BEHAVIORAL TAU - Phase 1
  • BEHAVIORAL CAMS - Phase 1
  • BEHAVIORAL DBT - Phase 1 and 2
  • BEHAVIORAL CAMS - Phase 2
  • BEHAVIORAL DBT - Phase 2

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-01-04
Est. Completion 2022-10-15
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT04728815

The ClinicalTrials.gov registry entry for NCT04728815 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which TAU - Phase 1 is the first listed.

NCT04728815 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04728815 about?

NCT04728815 is a clinical study titled "CAMPUS - Feasibility Sub-Study". 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 co...

What is the current status of trial NCT04728815?

This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2021-01-04. Estimated completion is 2022-10-15.

What interventions are being tested in trial NCT04728815?

The interventions under investigation include: TAU - Phase 1 (BEHAVIORAL), CAMS - Phase 1 (BEHAVIORAL), DBT - Phase 1 and 2 (BEHAVIORAL), CAMS - Phase 2 (BEHAVIORAL), DBT - Phase 2 (BEHAVIORAL).

Who is sponsoring clinical trial NCT04728815?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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