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CAMPUS - Feasibility Sub-Study (CAMPUS-Feas)

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ClinicalTrials.gov Identifier: NCT04728815
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Brief 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.


Condition or disease Intervention/treatment Phase
Suicide Behavioral: TAU - Phase 1 Behavioral: CAMS - Phase 1 Behavioral: DBT - Phase 1 and 2 Behavioral: CAMS - Phase 2 Behavioral: DBT - Phase 2 Not Applicable

Detailed Description:

We will enroll moderately to severely suicidal college students in the "emerging adulthood" phase (ages 18-25) seeking services at CCCs. Forty-four participants (N=44) 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=16); (2) Treatment as Usual (TAU) for 4-8 weeks (n=16); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=12), 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Participants 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=16); (2) Treatment as Usual (TAU) for 4-8 weeks (n=16); or (3) Comprehensive Dialectical Behavior Therapy (DBT) for 16 weeks (n=12), 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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
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: TAU - Phase 1
4-8 weeks of TAU treatment

Behavioral: CAMS - Phase 2
Up to 8 weeks of CAMS 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: TAU - Phase 1
4-8 weeks of TAU treatment

Behavioral: DBT - Phase 2
Up to 8 weeks of DBT 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




Primary Outcome Measures :
  1. Percentage of 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 percentage who agree to randomization to one of three treatments will be calculated.

  2. Counselor Recruitment [ Time Frame: To the end of initial counselor recruitment (up to 2 weeks) ]
    Among the counselors eligible to participate in the study, three counselors from each site will agree to participate.

  3. Treatment Adherence [ Time Frame: To the end of treatment period (up to 16 weeks) ]
    Existing gold-standard adherence instruments for CAMS and DBT will be used to rate a selection of sessions to assess counselors' fidelity to implementing the adaptive treatment strategies.

  4. Attendance [ Time Frame: To the end of treatment period (up to 16 weeks) ]
    The mean / median (depending on the distribution) number of sessions attended by students in each treatment condition, as well as the associated 95% confidence intervals, will be calculated.

  5. Attrition [ Time Frame: To the end of treatment period (up to 16 weeks) ]
    The mean / median (depending on the distribution) proportion of sessions attended by students in each treatment condition, as well as the associated 95% confidence intervals, will be calculated.

  6. Student Treatment Satisfaction [ Time Frame: To the end of treatment period (up to 16 weeks) ]
    An overall mean treatment satisfaction rating, and associated 95% confidence interval, will be calculated for each treatment condition based on students' responses on the Client Satisfaction Questionnaire (CSQ).

  7. 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 and DBT online trainings.

  8. Counselor Study Satisfaction [ Time Frame: To the end of study (up to 9 months) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728815


Contacts
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Contact: Ted Snyderman, MSW 919-668-3911 ted.snyderman@duke.edu
Contact: Kyla Blaylock, PhD 919-684-4686 kyla.blalock@duke.edu

Locations
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United States, Nevada
University of Nevada - Reno Recruiting
Reno, Nevada, United States, 89557
Contact: Francesca Kassing, PhD       fkassing@unr.edu   
Principal Investigator: Jacque Pistorello, PhD         
United States, New Jersey
Rutgers University Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Madison Taylor       mt1077@gsapp.rutgers.edu   
Principal Investigator: Shireen Rizvi, PhD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Ted Snyderman, MSW       ted.snyderman@duke.edu   
Principal Investigator: Scott Compton, PhD         
United States, Oregon
University of Oregon Recruiting
Eugene, Oregon, United States, 97403
Contact: James Sinclair, PhD       jamesin@uoregon.edu   
Principal Investigator: John Seeley, PhD         
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Investigators
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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
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04728815    
Other Study ID Numbers: Pro00104815
Pro00103346 ( Other Identifier: 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 )
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://nda.nih.gov/about/about-us.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Dialectical Behavior Therapy (DBT)
Collaborative Assessment and Management of Suicide (CAMS)
University Students
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms