SuicideCAMPUS-FeasNCT04728815

CAMPUS - Feasibility Sub-Study

A study testing TAU - Phase 1, CAMS - Phase 1 and DBT - Phase 1 and 2 in people with Suicide, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 25 years
Conditions the study is for: Suicide
What is being tested?: TAU - Phase 1, CAMS - Phase 1 and DBT - Phase 1 and 2
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 4 sitesUnited States
Study dates: 4 Jan 2021to 15 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Enrolled at the university;
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).
18 to 25 years of age;
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
Agree to video recording of all therapy and assessment sessions.

Who cannot join

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);
Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions);
Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Suicide
Being tested: TAU - Phase 1, CAMS - Phase 1, DBT - Phase 1 and 2, CAMS - Phase 2, DBT - Phase 2
Keywords: Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), University Students
Medical subject headings: Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAU - Phase 1Behavioural
4-8 weeks of TAU treatment
CAMS - Phase 1Behavioural
4-8 weeks of CAMS treatment
DBT - Phase 1 and 2Behavioural
up to 16 weeks of DBT treatment
CAMS - Phase 2Behavioural
Up to 8 weeks of CAMS treatment
DBT - Phase 2Behavioural
Up to 8 weeks of DBT treatment

Study groups in NCT04728815
Study group	Role	What they receive
CAMS to Maintenance	Experimental	Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring. Receives: Behavioral: CAMS - Phase 1
CAMS to CAMS	Experimental	Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS. Receives: Behavioral: CAMS - Phase 1; Behavioral: CAMS - Phase 2
CAMS to DBT	Experimental	Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT. Receives: Behavioral: CAMS - Phase 1; Behavioral: DBT - Phase 2
TAU to Maintenance	Experimental	Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring. Receives: Behavioral: TAU - Phase 1
TAU to CAMS	Experimental	Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS. Receives: Behavioral: TAU - Phase 1; Behavioral: CAMS - Phase 2
TAU to DBT	Experimental	Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT. Receives: Behavioral: TAU - Phase 1; Behavioral: DBT - Phase 2
DBT Only	Experimental	Subject Assigned to DBT for Phase 1, continuing up to 16 weeks. Receives: Behavioral: DBT - Phase 1 and 2
Study Counselors	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Number of Eligible Students Who Agree to Randomization
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.
Measured: To the end of initial Randomization (up to 1 week)
Counselor Recruitment
Among the counselors eligible to participate in the study, the number of counselors from each site who agree to participate.
Measured: To the end of initial counselor recruitment (up to 2 weeks)
Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale
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."
Measured: 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
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.
Measured: To the end of treatment period (up to 16 weeks)
Number of Sessions Attended by Students in Each Treatment Condition
Measured: 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)
Measured: To the end of treatment period (up to 16 weeks)
Student Treatment Satisfaction as Measured by the Client Satisfaction Questionnaire (CSQ)
CSQ items are rated from 1-4, with higher scores reflecting greater satisfaction.
Measured: To the end of treatment period (up to 16 weeks)
Counselor Training Satisfaction
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: Beginning to end of Stage 2 (up to 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202115 Oct 2022

First posted28 Jan 2021
Study start4 Jan 2021
Primary completion15 Oct 2022
Study completion15 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SuicideStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
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=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. There is an 8th Arm/Group of Consented Study Counselors from each of the 4 sites.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04728815
Sponsor's protocol ID: Pro00104815
Other IDs: Pro00103346, R01MH116062, R01MH116052, R01MH116050, R01MH116061
Acronym: CAMPUS-Feas
Status last verified: Feb 2024
First submitted: 25 Jan 2021
Last updated: 29 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Kassing F, Seeley JR, Rizvi SL, Compton SN, Sinclair J, Oshin LA, Blalock K, Jobes DA, Crumlish J, Stadelman S, Gozenman-Sapin F, Snyderman T, Ruork AK, Fry CM, Gallop RJ, Goodrich J, Pistorello J. Assessing the implementation of suicide-focused treatments delivered in hybrid telemental health format in a real-world setting. Psychother Res. 2025 Sep;35(7):1198-1212. doi: 10.1080/10503307.2024.2415104. Epub 2024 Oct 22.
PubMed 39439041

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Suicide trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comprehensive Adaptive Multisite Prevention of University Student Suicide (CAMPUS) - Feasibility Sub-Study
ClinicalTrials.gov ID: NCT04728815
Acronym / sponsor ID: CAMPUS-Feas / Pro00104815
Conditions: Suicide
Keywords: Dialectical Behavior Therapy (DBT), Collaborative Assessment and Management of Suicide (CAMS), University Students
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 4 Jan 2021 (actual)
Primary completion: 15 Oct 2022 (actual)
Study completion: 15 Oct 2022 (actual)
First posted: 28 Jan 2021 (actual)
Results: Posted 29 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 8
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=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. There is an 8th Arm/Group of Consented Study Counselors from each of the 4 sites.

Arm	Type	Receives
CAMS to Maintenance	Experimental	Behavioral: CAMS - Phase 1Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Responder, thus placed into ongoing Maintenance/Monitoring.
CAMS to CAMS	Experimental	Behavioral: CAMS - Phase 1, Behavioral: CAMS - Phase 2Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 CAMS.
CAMS to DBT	Experimental	Behavioral: CAMS - Phase 1, Behavioral: DBT - Phase 2Subject assigned to CAMS for Phase 1. Subject is a Phase 1 CAMS Insufficient Responder, then assigned to Phase 2 DBT.
TAU to Maintenance	Experimental	Behavioral: TAU - Phase 1Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Responder, thus placed into ongoing Maintenance/Monitoring.
TAU to CAMS	Experimental	Behavioral: TAU - Phase 1, Behavioral: CAMS - Phase 2Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 CAMS.
TAU to DBT	Experimental	Behavioral: TAU - Phase 1, Behavioral: DBT - Phase 2Subject assigned to TAU for Phase 1. Subject is a Phase 1 TAU Insufficient Responder, then assigned to Phase 2 DBT.
DBT Only	Experimental	Behavioral: DBT - Phase 1 and 2Subject Assigned to DBT for Phase 1, continuing up to 16 weeks.
Study Counselors	No intervention	–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.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Enrolled at the university;
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).
18 to 25 years of age;
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
Agree to video recording of all therapy and assessment sessions.

Key exclusion criteria (3 listed)

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);
Students being unable to remain enrolled in their university long enough to go through the minimum number of sessions for Stage 1 (4 sessions);
Students who have received services at the CCC within the last three months (i.e., ATSs must be based on a new treatment episode).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAU - Phase 14-8 weeks of TAU treatment	Behavioural	TAU to CAMS, TAU to DBT, TAU to Maintenance
CAMS - Phase 14-8 weeks of CAMS treatment	Behavioural	CAMS to CAMS, CAMS to DBT, CAMS to Maintenance
DBT - Phase 1 and 2up to 16 weeks of DBT treatment	Behavioural	DBT Only
CAMS - Phase 2Up to 8 weeks of CAMS treatment	Behavioural	CAMS to CAMS, TAU to CAMS
DBT - Phase 2Up to 8 weeks of DBT treatment	Behavioural	CAMS to DBT, TAU to DBT

Primary outcome

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.
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.
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."
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.
Number of Sessions Attended by Students in Each Treatment Condition
Time frame: 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)
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.
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).
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.
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.

Results and safety

Results posted to the registry on 29 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAMS to Maintenance	12	9
CAMS to CAMS	8	3
CAMS to DBT	10	5
TAU to Maintenance	4	3
TAU to CAMS	7	3
TAU to DBT	1	0
DBT Only	26	14
Study Counselors	16	16

Primary outcome: Number of Eligible Students Who Agree to Randomization

Time frame: To the end of initial Randomization (up to 1 week). Count of participants. Unit: Participants

Measure	Duke University n = 12	Rutgers University n = 40	University of Nevada, Reno n = 54	University of Oregon n = 37
Value	8	24	20	16

Population analysed: Students meeting all inclusion criteria and no exclusion criteria.

Primary outcome: Counselor Recruitment

Time frame: To the end of initial counselor recruitment (up to 2 weeks). Count of participants. Unit: Participants

Measure	Duke University n = 4	Rutgers University n = 4	University of Nevada, Reno n = 4	University of Oregon n = 4
Value	4	4	4	4

Population analysed: Counselors meeting all inclusion criteria and no exclusion criteria.

Primary outcome: Treatment Adherence as Measured by DBT (Dialectical Behavior Therapy) Adherence Rating Scale

Time frame: To the end of treatment period (up to 16 weeks). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Duke University n = 2	Rutgers University n = 4	University of Nevada, Reno n = 4	University of Oregon n = 4
Value	3.5 (3.18 to 3.82)	3.68 (3.61 to 3.75)	3.72 (3.62 to 3.81)	3.81 (3.74 to 3.89)

Population analysed: Participants whose DBT sessions were rated.

Primary outcome: 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). Mean (95% Confidence Interval). Unit: score on a scale

Measure	Duke University n = 2	Rutgers University n = 4	University of Nevada, Reno n = 3	University of Oregon n = 4
Value	4.05 (3.37 to 4.73)	4.66 (4.32 to 5.01)	4.45 (4.05 to 4.86)	4.77 (4.39 to 5.15)

Population analysed: Participants whose CAMS sessions were rated.

Adverse events

Time frame: To the end of study (up to 9 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 2 - CAMS to Maintenance	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Stage 2 - CAMS to CAMS	0 of 8 (0%)	0 of 5 (0%)	0 of 5
Stage 2 - CAMS to DBT	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Stage 2 - TAU to Maintenance	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Stage 2 - TAU to CAMS	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Stage 2 - TAU to DBT	0 of 1 (0%)	0 of 1 (0%)	0 of 1
DBT Only	4 of 26 (15.4%)	3 of 26 (11.5%)	0 of 26
Stage 1 CAMS	4 of 30 (13.3%)	9 of 30 (30%)	0 of 30
Stage 1 TAU	1 of 12 (8.3%)	3 of 12 (25%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39439041Kassing F, Seeley JR, Rizvi SL, Compton SN, Sinclair J, Oshin LA, Blalock K, Jobes DA, Crumlish J, Stadelman S, Gozenman-Sapin F, Snyderman T, Ruork AK, Fry CM, Gallop RJ, Goodrich J, Pistorello J. Assessing the implementation of suicide-focused treatments delivered in hybrid telemental health format in a real-world setting. Psychother Res. 2025 Sep;35(7):1198-1212. doi: 10.1080/10503307.2024.2415104. Epub 2024 Oct 22.
Individual participant dataSharing planned: Yes. 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.

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Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Compton, PhD principal investigator

Duke University

Jacqueline Pistorello, PhD principal investigator

University of Nevada at Reno (UNR)

Shireen Rizvi, PhD principal investigator

Rutgers University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TAU - Phase 1, CAMS - Phase 1 and DBT - Phase 1 and 2 in people with Suicide, run by Duke University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Eligible Students Who Agree to Randomization (time frame: To the end of initial Randomization (up to 1 week)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04728815, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.