SuicideSMARTNCT02442869

Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

A study testing Stage 1 Treatment as usual (TAU), Stage 1 CAMS and Stage 2 CAMS in people with Suicide, run by University of Nevada, Reno at 1 site 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?: Stage 1 Treatment as usual (TAU), Stage 1 CAMS and Stage 2 CAMS
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 16 Jun 2015to 30 Dec 2016
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 student at the University of Nevada, Reno (UNR)
Seeking services at Counseling Services at UNR
18 to 25 years of age
Moderate to severe suicidality (indicated by a score of 2 or above (range is 0 "not at all like me" to 4 "extremely like me") on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34; Locke et al., 2012) question, "I have thoughts of ending my life."

Who cannot join

Individual is deemed inappropriate to receive services at UNR Counseling Services by the intake worker (the primary exclusion criterion).
Participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Counseling Services, University of Nevada, Reno
Reno, Nevada, 89557

Other trials in United States

About this study

This pilot study tested the feasibility of utilizing an adaptive intervention strategy for college students who are suicidal when first seeking treatment at a campus clinic. Right now, the typical strategy may rely on a "one size fits all" approach, but in fact suicidal students vary greatly on what and how much they need. This study will pave the way for subsequent larger trials for clinical decision making (trying one approach, and if that doesn't work, another) to be empirically developed and tested in a subsequent large-scale multisite trial with the goal of maximizing resources in overburdened college counseling centers. This pilot study followed by a subsequent large-scale trial could eventually significantly impact service delivery to suicidal college students at college counseling centers.

Read the detailed description

The primary aim of this proposal was to conduct feasibility research to inform the implementation of a future full-scale SMART (sequential, multiple assignment, randomized trial, Almirall et al., 2012) that will be used to construct adaptive treatment strategies (ATSs) to address suicidality in college students seeking services at college counseling centers (CCCs). ATSs individualize treatment via decision rules that can specify how the type and intensity of an intervention should be sequenced based on variables collected mid-treatment (or at baseline), such as response to treatment. Suicidality is a frequent presenting concern among college students seeking treatment; yet, studies with this population show that some students respond rapidly to treatment whereas others may require considerably more resources. However, at this time, CCCs, which are overburdened and often have to resort to waitlists, have no guidance as to how to sequence different approaches with suicidal students in an empirically-based and cost effective manner. Therefore, empirically validated ATSs are needed in the provision of services to suicidal college students to address the heterogeneity of students with this presentation and the variability in response to interventions. In the present pilot SMART, each participant progressed through two stages of intervention. In the first stage (S1) 62 participants were randomized to one of two brief individual therapy interventions for 4-8 weeks: 1) one that is suicidality-focused (Collaborative Assessment and Management of Suicidality (CAMS; Jobes, 2016) and 2) one that relies on Treatment as Usual (TAU) being provided at a CCC. Responders to either program will discontinue services/ be stepped down and be monitored over time for maintenance. Non-responders to either intervention who remain in treatment (estimated n = 18) were re-randomized to one of two second-stage (S2) higher intensity/dosage intervention options for an additional 4-16 weeks: 1) CAMS (either continued but for a longer period of time or administered for the first time) or 2) Comprehensive Dialectical Behavior Therapy (DBT, Linehan, 1993a, 1993b) which includes individual therapy, skills groups, and phone coaching for the clients and DBT peer consultation for the therapists. This study enrolled moderately to severely suicidal (endorsing thoughts of wanting to die of 2 or above on 0-4 scale) college students in the "emerging adulthood" phase (18-25 years of age) seeking services at a CCC. The aims of this feasibility services research project were to 1) develop and refine a SMART design in a CCC setting; 2) assess the feasibility of conducting a SMART and its embedded ATSs in a CCC setting; 3) obtain estimates of overall response rates to S1 interventions; and 4) explore the utility of incorporating secondary tailoring variables (e.g., level of functioning at pre-treatment, ratio of Wish to Live vs. Wish to Die) in the ATSs in the subsequent larger trial.

Conditions: Suicide
Being tested: Stage 1 Treatment as usual (TAU), Stage 1 CAMS, Stage 2 CAMS, Stage 2 Dialectical Behavioral Therapy (DBT)
Keywords: Suicide, College student mental health, CAMS- Collaborative Assessment and Management of Suicidality, SMART -- Sequential Multiple Assignment Randomized Trial, DBT -- Dialectical Behavior Therapy, ATS -- Adaptive Treatment Strategy
Medical subject headings: Suicide

What participants receive

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

Stage 1 Treatment as usual (TAU)Behavioural
4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.
Stage 1 CAMSBehavioural
4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Stage 2 CAMSBehavioural
4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Stage 2 Dialectical Behavioral Therapy (DBT)Behavioural
4-16 weeks of Dialectical Behavioral Therapy (DBT)

Study groups in NCT02442869
Study group	Role	What they receive
Stage 1 TAU plus Stage 2 CAMS	Experimental	Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks Receives: Behavioral: Stage 1 Treatment as usual (TAU); Behavioral: Stage 2 CAMS
Stage 1 TAU plus Stage 2 DBT	Experimental	Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Dialectical Behavioral Therapy (DBT) for 4-16 weeks Receives: Behavioral: Stage 1 Treatment as usual (TAU); Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)
Stage 1 CAMS plus Stage 2 CAMS	Experimental	Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Additional Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks Receives: Behavioral: Stage 1 CAMS; Behavioral: Stage 2 CAMS
Stage 1 CAMS plus Stage 2 DBT	Experimental	Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Dialectical Behavioral Therapy (DBT) for 4-16 weeks Receives: Behavioral: Stage 1 CAMS; Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)

What is being measured

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

Feasibility/Acceptability: Participation Rate
Number of students approached who agreed to participate in the study
Measured: Baseline
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why
Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Measured: Baseline
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies
Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies
Measured: After Stage 2
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm
General time to drop out among students who dropped out within each arm, by number of treatment sessions received
Measured: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)
CAMS adherence ratings conducted by CAMS experts. The CAMS Rating Scale (CRS.3) was used to assess CAMS adherence. The CRS.3 has 14 items rated on a 7-point scale from 0 (Poor) to 6 (Excellent). Therefore, higher scores indicate better adherence. Adherence covers various domains: collaboration (4 items), suicide focus (1 item), risk assessment (1 item), treatment planning (3 items), intervention (2 items), and overall adherence (1 item). Two coders assessed the fidelity of CAMS by observing digitally recorded sessions.
Measured: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003)
DBT adherence ratings conducted by DBT adherence experts. The University of Washington Dialectical Behavior Therapy Adherence Coding Scale (DBTACS) was utilized to check DBT adherence. The DBTACS has various dimensions, each measured on a 5-point scale (ranging from 0.0-5.0, with 5 indicating greater adherence). Therefore, higher scores indicate better adherence. The overall score is an average of these dimensions with a cutoff of 4.0 for adherence.
Measured: During Stage 2 (sessions 9 through 24 of treatment)
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) assesses client satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQ score of 8-20); Medium satisfaction ratings (CSQ score of 21-26); High satisfaction ratings (CSQ score of 27-32).
Measured: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)
The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).
Measured: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)

Secondary outcomes (1)

Scale for Suicide Ideation-Current (SSI)
The SSI is an interviewer-rated measure based on 19 questions related to the highest intensity of suicidal ideation in the past 2 weeks, including attitudes, behaviors, and plans. Each item is rated as 0,1, or 2 and the total scale yields a score of 0-38. Higher scores indicate greater suicide risk.
Measured: End of Stage 1 interventions - ~8 weeks after baseline; End of Stage 2 interventions ~24 weeks after baseline; and Follow-up (3 months after all treatment has ended) ~36 weeks after baseline

Timeline

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

16 Jun 201530 Dec 2016

First posted13 May 2015 (estimated)
Study start16 Jun 2015
Primary completion30 Dec 2016
Study completion30 Dec 2016

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 (12)Papers the sponsor has linked to this study.
Other trials for SuicideStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study used a Sequential Multiple Assignment Randomized Trial (SMART) design to pilot 4 adaptive treatment strategies (ATSs): ATS1 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS2 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 DBT. ATS3 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS4 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 DBT. For Stage 1, we hypothesized that CAMS would show more improvement on suicide-related variables than TAU and would be more effective with suicidal college students presenting with less complexity at baseline. We did not identify hypotheses for clinical outcome variables in Stage 2 because it was exploratory in nature and focused on the feasibility and acceptability of implementing a SMART design to address suicidal risk in college students.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02442869
Sponsor's protocol ID: 603856
Other IDs: R34MH104714
Acronym: SMART
Status last verified: Feb 2021
First submitted: 16 Apr 2015
Last updated: 1 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: After study is complete and data analyzed, interested researchers can contact the PI for data inquiries. Only de-identified data will be released to qualified researchers.

Publications

Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
PubMed 10842426
Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
PubMed 22438190
American College Health Association (ACHA, 2012). ACHA-National College Health Assessment II: Reference group executive summary Spring 2011. Hanover MD: American College Health Association.
Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available.
PubMed 469082
Comtois KA, Jobes DA, S O'Connor S, Atkins DC, Janis K, E Chessen C, Landes SJ, Holen A, Yuodelis-Flores C. Collaborative assessment and management of suicidality (CAMS): feasibility trial for next-day appointment services. Depress Anxiety. 2011 Nov;28(11):963-72. doi: 10.1002/da.20895. Epub 2011 Sep 21.
PubMed 21948348
Center for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.
Jobes, D. A. (2006). Managing suicidal risk: A collaborative approach. New York: The Guilford Press.
Linehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963
Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.
Pistorello J, Jobes DA, Gallop R, Compton SN, Locey NS, Au JS, Noose SK, Walloch JC, Johnson J, Young M, Dickens Y, Chatham P, Jeffcoat T. A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality (CAMS) Versus Treatment as Usual (TAU) for Suicidal College Students. Arch Suicide Res. 2021 Oct-Dec;25(4):765-789. doi: 10.1080/13811118.2020.1749742. Epub 2020 Apr 10.
PubMed 32275480
Pistorello J, Jobes DA, Compton SN, Locey NS, Walloch JC, Gallop R, Au JS, Noose SK, Young M, Johnson J, Dickens Y, Chatham P, Jeffcoat T, Dalto G, Goswami S. Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). Arch Suicide Res. 2017 Oct-Dec;22(4):644-664. doi: 10.1080/13811118.2017.1392915. Epub 2018 Feb 12.
PubMed 29220633

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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
ClinicalTrials.gov ID: NCT02442869
Acronym / sponsor ID: SMART / 603856
Conditions: Suicide
Keywords: Suicide, College student mental health, CAMS- Collaborative Assessment and Management of Suicidality, SMART -- Sequential Multiple Assignment Randomized Trial, DBT -- Dialectical Behavior Therapy, ATS -- Adaptive Treatment Strategy
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of Nevada, RenoUniversity, hospital or other
Collaborators: The Catholic University of America, National Institute of Mental Health (NIMH)
Study start: 16 Jun 2015 (actual)
Primary completion: 30 Dec 2016 (actual)
Study completion: 30 Dec 2016 (actual)
First posted: 13 May 2015 (estimated)
Results: Posted 1 Mar 2021

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: This study used a Sequential Multiple Assignment Randomized Trial (SMART) design to pilot 4 adaptive treatment strategies (ATSs): ATS1 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS2 - Start with Stage 1 CAMS; if responding, end treatment; if not, continue on to Stage 2 DBT. ATS3 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 CAMS. ATS4 - Start with Stage 1 TAU; if responding, end treatment; if not, continue on to Stage 2 DBT. For Stage 1, we hypothesized that CAMS would show more improvement on suicide-related variables than TAU and would be more effective with suicidal college students presenting with less complexity at baseline. We did not identify hypotheses for clinical outcome variables in Stage 2 because it was exploratory in nature and focused on the feasibility and acceptability of implementing a SMART design to address suicidal risk in college students.

Arm	Type	Receives
Stage 1 TAU plus Stage 2 CAMS	Experimental	Behavioral: Stage 1 Treatment as usual (TAU), Behavioral: Stage 2 CAMSTreatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks
Stage 1 TAU plus Stage 2 DBT	Experimental	Behavioral: Stage 1 Treatment as usual (TAU), Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)Treatment as usual [TAU] -- the treatment typically provided by the counselor for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Dialectical Behavioral Therapy (DBT) for 4-16 weeks
Stage 1 CAMS plus Stage 2 CAMS	Experimental	Behavioral: Stage 1 CAMS, Behavioral: Stage 2 CAMSCollaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Additional Collaborative Assessment and Management of Suicidality (CAMS) for 4-16 weeks
Stage 1 CAMS plus Stage 2 DBT	Experimental	Behavioral: Stage 1 CAMS, Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)Collaborative Assessment and Management of Suicidality (CAMS) for 4-8 weeks If participant is responding, treatment ends. Participants who don't respond are then re-randomized to Dialectical Behavioral Therapy (DBT) for 4-16 weeks

Who may qualify

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

Key inclusion criteria (4 listed)

Enrolled student at the University of Nevada, Reno (UNR)
Seeking services at Counseling Services at UNR
18 to 25 years of age
Moderate to severe suicidality (indicated by a score of 2 or above (range is 0 "not at all like me" to 4 "extremely like me") on the Counseling Center Assessment of Psychological Symptoms (CCAPS-34; Locke et al., 2012) question, "I have thoughts of ending my life."

Key exclusion criteria (2 listed)

Individual is deemed inappropriate to receive services at UNR Counseling Services by the intake worker (the primary exclusion criterion).
Participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.

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
Stage 1 Treatment as usual (TAU)4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.	Behavioural	Stage 1 TAU plus Stage 2 CAMS, Stage 1 TAU plus Stage 2 DBT
Stage 1 CAMS4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Behavioural	Stage 1 CAMS plus Stage 2 CAMS, Stage 1 CAMS plus Stage 2 DBT
Stage 2 CAMS4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)	Behavioural	Stage 1 CAMS plus Stage 2 CAMS, Stage 1 TAU plus Stage 2 CAMS
Stage 2 Dialectical Behavioral Therapy (DBT)4-16 weeks of Dialectical Behavioral Therapy (DBT)	Behavioural	Stage 1 CAMS plus Stage 2 DBT, Stage 1 TAU plus Stage 2 DBT

Primary outcome

Feasibility/Acceptability: Participation Rate
Time frame: Baseline
Number of students approached who agreed to participate in the study
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why
Time frame: Baseline
Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies
Time frame: After Stage 2
Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm
Time frame: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
General time to drop out among students who dropped out within each arm, by number of treatment sessions received
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)
Time frame: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
CAMS adherence ratings conducted by CAMS experts. The CAMS Rating Scale (CRS.3) was used to assess CAMS adherence. The CRS.3 has 14 items rated on a 7-point scale from 0 (Poor) to 6 (Excellent). Therefore, higher scores indicate better adherence. Adherence covers various domains: collaboration (4 items), suicide focus (1 item), risk assessment (1 item), treatment planning (3 items), intervention (2 items), and overall adherence (1 item). Two coders assessed the fidelity of CAMS by observing digitally recorded sessions.
Feasibility/Acceptability: Fidelity of the DBT Intervention Delivery by "Real World" CCC Counselors Via the University of Washington DBT Adherence Rating Scale (Linehan & Korslund, 2003)
Time frame: During Stage 2 (sessions 9 through 24 of treatment)
DBT adherence ratings conducted by DBT adherence experts. The University of Washington Dialectical Behavior Therapy Adherence Coding Scale (DBTACS) was utilized to check DBT adherence. The DBTACS has various dimensions, each measured on a 5-point scale (ranging from 0.0-5.0, with 5 indicating greater adherence). Therefore, higher scores indicate better adherence. The overall score is an average of these dimensions with a cutoff of 4.0 for adherence.
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)
Time frame: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
The Client Satisfaction Questionnaire (CSQ-8) assesses client satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQ score of 8-20); Medium satisfaction ratings (CSQ score of 21-26); High satisfaction ratings (CSQ score of 27-32).
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)
Time frame: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
The Client Satisfaction Questionnaire (CSQ-8) Therapist Version assesses therapist satisfaction with treatment on a scale from 8-32, with higher scores indicating greater satisfaction. Low satisfaction ratings (CSQT score of 8-20); Medium satisfaction ratings (CSQT score of 21-26); High satisfaction ratings (CSQT score of 27-32).

1 secondary outcome

Scale for Suicide Ideation-Current (SSI)
Time frame: End of Stage 1 interventions - ~8 weeks after baseline; End of Stage 2 interventions ~24 weeks after baseline; and Follow-up (3 months after all treatment has ended) ~36 weeks after baseline

Results and safety

Results posted to the registry on 1 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 TAU (Participant Responding to Treatment)	18	13
Stage 1 CAMS (Participant Responding to Treatment)	29	20
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)	6	6
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)	2	1
Stage 2 DBT (Didn't Respond to Stage 1 TAU)	5	3
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)	2	2

Primary outcome: Feasibility/Acceptability: Participation Rate

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Agreed to Participate n = 62	Declined to Participate n = 30
Value	18	29

Primary outcome: Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why

Time frame: Baseline. Number. Unit: students

Measure	Num. of Students Declining & Agreeing to Participate n = 92
Declined when approached by counselor	23
Declined during the consenting process	7
Agreed: Enrolled & Randomized in study	62

Population analysed: Note the 'Overall Number of Participants Analyzed' in this context is the total number of eligible students and not the total number who consented to participate (intent to treat).

Primary outcome: Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies

Time frame: After Stage 2. Count of participants. Unit: Participants

Measure	Stage 1 TAU (Participant Responding to Treatment) n = 18	Stage 1 CAMS (Participant Responding to Treatment) n = 29	Stage 2 CAMS (Didn't Respond to Stage 1 TAU) n = 6	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n = 2	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n = 5	Stage 2 DBT (Didn't Respond to Stage 1 CAMS) n = 2
Retained	13	20	6	1	3	2
Dropped	5	9	0	1	2	0

Population analysed: All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not

Primary outcome: Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm

Time frame: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2). Count of participants. Unit: Participants

Measure	Stage 1 TAU (Participant Responding to Treatment) n = 5	Stage 1 CAMS (Participant Responding to Treatment) n = 9	Stage 2 CAMS (Didn't Respond to Stage 1 CAMS) n = 1	Stage 2 DBT (Didn't Respond to Stage 1 TAU) n = 2
Attended 0 sessions	0	2	0	0
Attended 1-2 sessions	2	4	0	0
Attended 3-5 sessions	1	0	0	0
Attended 6 or more sessions	2	3	1	2

Population analysed: Columns/Arms with zero (0) participants indicates that no participants dropped out of that particular Arm of the study, but note the small sample size. All participants were assessed at the end of the Stage 2 (approximately 6 months after baseline), regardless of whether they continued into Stage 2 treatments or not

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected during both Phases of the study through the follow-up assessment (approximately 6 months after baseline, for a total of approximately 6 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 TAU (Participant Responding to Treatment)	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Stage 1 CAMS (Participant Responding to Treatment)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Stage 2 CAMS (Didn't Respond to Stage 1 TAU)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Stage 2 CAMS (Didn't Respond to Stage 1 CAMS)	2 of 2 (100%)	0 of 2 (0%)	0 of 2
Stage 2 DBT (Didn't Respond to Stage 1 TAU)	2 of 5 (40%)	0 of 5 (0%)	0 of 5
Stage 2 DBT (Didn't Respond to Stage 1 CAMS)	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The study focused on acceptability and feasibility. Although data was collected for Stage 2 and analyzed for acceptability and feasibility outcomes (e.g., CSQ), clinical outcomes (e.g., SSI, CCAPS) were only interpreted for Stage 1 due to small sample sizes among the Stage 2 groups. A larger study is needed to identify the most effective sequence of care for suicidal risk treatments at college counseling centers.

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10842426Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
Background: PubMed 22438190Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat Med. 2012 Jul 30;31(17):1887-902. doi: 10.1002/sim.4512. Epub 2012 Mar 22.
BackgroundAmerican College Health Association (ACHA, 2012). ACHA-National College Health Assessment II: Reference group executive summary Spring 2011. Hanover MD: American College Health Association.
Background: PubMed 469082Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available.
Background: PubMed 21948348Comtois KA, Jobes DA, S O'Connor S, Atkins DC, Janis K, E Chessen C, Landes SJ, Holen A, Yuodelis-Flores C. Collaborative assessment and management of suicidality (CAMS): feasibility trial for next-day appointment services. Depress Anxiety. 2011 Nov;28(11):963-72. doi: 10.1002/da.20895. Epub 2011 Sep 21.
BackgroundCenter for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.
BackgroundJobes, D. A. (2006). Managing suicidal risk: A collaborative approach. New York: The Guilford Press.
BackgroundLinehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.
Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
BackgroundLinehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.
Results publication: PubMed 32275480Pistorello J, Jobes DA, Gallop R, Compton SN, Locey NS, Au JS, Noose SK, Walloch JC, Johnson J, Young M, Dickens Y, Chatham P, Jeffcoat T. A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality (CAMS) Versus Treatment as Usual (TAU) for Suicidal College Students. Arch Suicide Res. 2021 Oct-Dec;25(4):765-789. doi: 10.1080/13811118.2020.1749742. Epub 2020 Apr 10.
Results publication: PubMed 29220633Pistorello J, Jobes DA, Compton SN, Locey NS, Walloch JC, Gallop R, Au JS, Noose SK, Young M, Johnson J, Dickens Y, Chatham P, Jeffcoat T, Dalto G, Goswami S. Developing Adaptive Treatment Strategies to Address Suicidal Risk in College Students: A Pilot Sequential, Multiple Assignment, Randomized Trial (SMART). Arch Suicide Res. 2017 Oct-Dec;22(4):644-664. doi: 10.1080/13811118.2017.1392915. Epub 2018 Feb 12.
Individual participant dataSharing planned: Yes. After study is complete and data analyzed, interested researchers can contact the PI for data inquiries. Only de-identified data will be released to qualified researchers.

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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.

Jacqueline Pistorello, PhD principal investigator

University of Nevada, Reno

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

Questions about this trial

What is this clinical trial studying?

A study testing Stage 1 Treatment as usual (TAU), Stage 1 CAMS and Stage 2 CAMS in people with Suicide, run by University of Nevada, Reno at 1 site 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 4 inclusion and 2 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 Mar 2021). 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?

Feasibility/Acceptability: Participation Rate (time frame: Baseline). The study lists 8 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 NCT02442869, which also lists 12 linked publications.

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 1 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.