CAMPUS - Feasibility Sub-Study (CAMPUS-Feas)

February 2, 2024 updated by: Duke University

Comprehensive Adaptive Multisite Prevention of University Student Suicide (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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Reno, Nevada, United States, 89557
        • University of Nevada - Reno
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Oregon
      • Eugene, Oregon, United States, 97403
        • University of Oregon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Enrolled at the university;
  2. Eligible to receive counseling services either in person or remotely at the campus CCC (e.g., some students who are living in specific states may not be eligible for therapeutic services).
  3. 18 to 25 years of age;
  4. Moderate to severe SI over the last two weeks indicated by a score of greater than or equal to 2 on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34) question, "I have thoughts of ending my life" (range is 0 "not at all like me" to 4 "extremely like me"); and
  5. Agree to video recording of all therapy and assessment sessions.

Exclusion Criteria:

  1. Students who are deemed clinically inappropriate to receive services at the CCC by an intake counselor because of imminent risk, severe psychosis, or inability to remain enrolled in school (e.g., academic failure);
  2. Students being unable to remain enrolled in their university long enough to go through the minimum number 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAMS to Maintenance
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
Behavioral: CAMS - Phase 1
4-8 weeks of CAMS treatment
Experimental: CAMS to CAMS
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
Behavioral: CAMS - Phase 1
4-8 weeks of CAMS treatment
Behavioral: CAMS - Phase 2
Up to 8 weeks of CAMS treatment
Experimental: CAMS to DBT
Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
Behavioral: CAMS - Phase 1
4-8 weeks of CAMS treatment
Behavioral: DBT - Phase 2
Up to 8 weeks of DBT treatment
Experimental: TAU to Maintenance
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
Behavioral: TAU - Phase 1
4-8 weeks of TAU treatment
Experimental: TAU to CAMS
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
Behavioral: CAMS - Phase 2
Up to 8 weeks of CAMS treatment
Behavioral: TAU - Phase 1
4-8 weeks of TAU treatment
Experimental: TAU to DBT
Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
Behavioral: DBT - Phase 2
Up to 8 weeks of DBT treatment
Behavioral: TAU - Phase 1
4-8 weeks of TAU treatment
Experimental: DBT Only
Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
Behavioral: DBT - Phase 1 and 2
up to 16 weeks of DBT treatment
No Intervention: Study Counselors
Consented Study Counselors from each of the 4 sites. Data collected regarding the Counselors is minimal and is maintained completely separately from the other 7 Student Participant Arms/Groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Eligible Students Who Agree to Randomization
Time Frame: To the end of initial Randomization (up to 1 week)
Among students who are eligible to participate in the study and approached about the study by an intake worker, the number who agree to randomization to one of three treatments will be reported.
To the end of initial Randomization (up to 1 week)
Counselor Recruitment
Time Frame: To the end of initial counselor recruitment (up to 2 weeks)
Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate.
To the end of initial counselor recruitment (up to 2 weeks)
Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale
Time Frame: To the end of treatment period (up to 16 weeks)
Existing gold-standard adherence instruments for DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. Each item is rated on a scale where 0 = not used/not necessary, 1-3 = below adherence, 4 = minimum threshold for adherence, and 5 = adherent with high sufficiency. The DBT ACS is scored by averaging all non-zero items to create a computed global score where 3.8 and higher is considered "adherent."
To the end of treatment period (up to 16 weeks)
Treatment Adherence as Measured by CAMS (Collaborative Assessment and Management of Suicidality) Adherence Rating Scale
Time Frame: To the end of treatment period (up to 16 weeks)
Existing gold-standard adherence instruments for CAMS will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies. The measure consists of 14 items evaluating clinician performance, all rated on a seven-point Likert scale ranging from 0 ("Poor") to 6 ("Excellent"). A session is rated as adherent with a score of 3.5 or greater.
To the end of treatment period (up to 16 weeks)
Number of Sessions Attended by Students in Each Treatment Condition
Time Frame: To the end of treatment period (up to 16 weeks)
To the end of treatment period (up to 16 weeks)
Number of Students Who Attrite From the Study (by Withdrawing Early From Treatment or Dropping Out of the Trial)
Time Frame: To the end of treatment period (up to 16 weeks)
To the end of treatment period (up to 16 weeks)
Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
Time Frame: To the end of treatment period (up to 16 weeks)
CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction.
To the end of treatment period (up to 16 weeks)
Counselor Training Satisfaction
Time Frame: To end of initial training period (up to 4 weeks)
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the Continuing Education Unit (CEU) evaluation surveys for the CAMS (Collaborative Assessment and Management of Suicidality) and DBT (Dialectical Behavior Therapy) online trainings. Item scores range from 1 (Not at all valuable) to 5 (Extremely valuable).
To end of initial training period (up to 4 weeks)
Counselor Assessment of Participant Study Satisfaction During Stage 1 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
Time Frame: To the end of stage 1 (up to 8 weeks)
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.
To the end of stage 1 (up to 8 weeks)
Counselor Assessment of Participant Study Satisfaction During Stage 2 of Treatment as Measured by the Client Satisfaction Questionnaire (CSQ)
Time Frame: Beginning to end of Stage 2 (up to 8 weeks)
An overall mean treatment satisfaction rating and the associated 95% confidence interval will be calculated based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). Items rated from 1-4, with higher scores reflecting greater satisfaction. Participants were assessed for overall mean treatment satisfaction rating based on counselors' responses on the counselor version of the Client Satisfaction Questionnaire (CSQ). The counselor version of the CSQ is completed by the counselor, based on their assessment of how the subject appreciated and benefited from treatment.
Beginning to end of Stage 2 (up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Compton, PhD, Duke University
  • Principal Investigator: Jacqueline Pistorello, PhD, University of Nevada at Reno (UNR)
  • Principal Investigator: Shireen Rizvi, PhD, Rutgers University
  • Principal Investigator: John Seeley, PhD, University of Oregon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00104815 (Other Identifier: Duke University IRB)
  • Pro00103346 (Duke IRB)
  • R01MH116062 (U.S. NIH Grant/Contract)
  • R01MH116052 (U.S. NIH Grant/Contract)
  • R01MH116050 (U.S. NIH Grant/Contract)
  • R01MH116061 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will participant de-identified data (linked only by GUID) with the National Institute of Mental Health Data Archive (NDA). The NDA is an informatics system and research data repository developed by the National Institutes of Health (NIH) to share research data. The NDA provides the infrastructure to store, search across, and analyze various types of data. In addition, The NDA provides longitudinal storage of a research participant's information generated by one or more research studies. In other words, the NDA is able to associate a single research participant's genomic, imaging, clinical assessment and other information even if the data were collected at different locations or through different studies. By doing so, the NDA gives researchers access to more data than they can collect on their own, making it easier and faster for researchers to gather, evaluate, and share research information from a variety of sources.

IPD Sharing Time Frame

All subject data will be submitted for inclusion in the NDA, through the conclusion of data collection activities. Data is to be submitted cumulatively, every 6 months.

IPD Sharing Access Criteria

The NIH will provide access to scientific investigators for research purposes. Qualified researchers who have completed a Data Use Certification and received approval from the NDA Data Access Committee (DAC) may be approved to access broadly shared data. A separate request process exists for access to data in federated sources. Additionally, the DAC and support staff at NIH have access to NDA shared data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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