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Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART (SMART)

Primary Purpose

Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stage 1 Treatment as usual (TAU)
Stage 1 CAMS
Stage 2 CAMS
Stage 2 Dialectical Behavioral Therapy (DBT)
Sponsored by
University of Nevada, Reno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring 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

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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."

Exclusion Criteria:

  • 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.

Sites / Locations

  • Counseling Services, University of Nevada, Reno

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1 TAU plus Stage 2 CAMS

Stage 1 TAU plus Stage 2 DBT

Stage 1 CAMS plus Stage 2 CAMS

Stage 1 CAMS plus Stage 2 DBT

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Feasibility/Acceptability: Participation Rate
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
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
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
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)
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)
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)
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)
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).

Secondary Outcome Measures

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.

Full Information

First Posted
April 16, 2015
Last Updated
February 9, 2021
Sponsor
University of Nevada, Reno
Collaborators
The Catholic University of America, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02442869
Brief Title
Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Acronym
SMART
Official Title
Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 16, 2015 (Actual)
Primary Completion Date
December 30, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nevada, Reno
Collaborators
The Catholic University of America, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The Independent Evaluator was blind to condition assignment when conducting the assessments.
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 TAU plus Stage 2 CAMS
Arm Type
Experimental
Arm Description
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
Arm Title
Stage 1 TAU plus Stage 2 DBT
Arm Type
Experimental
Arm Description
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
Arm Title
Stage 1 CAMS plus Stage 2 CAMS
Arm Type
Experimental
Arm Description
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
Arm Title
Stage 1 CAMS plus Stage 2 DBT
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stage 1 Treatment as usual (TAU)
Intervention Description
4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.
Intervention Type
Behavioral
Intervention Name(s)
Stage 1 CAMS
Intervention Description
4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Intervention Type
Behavioral
Intervention Name(s)
Stage 2 CAMS
Intervention Description
4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Intervention Type
Behavioral
Intervention Name(s)
Stage 2 Dialectical Behavioral Therapy (DBT)
Intervention Description
4-16 weeks of Dialectical Behavioral Therapy (DBT)
Primary Outcome Measure Information:
Title
Feasibility/Acceptability: Participation Rate
Description
Number of students approached who agreed to participate in the study
Time Frame
Baseline
Title
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why
Description
Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Time Frame
Baseline
Title
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies
Description
Feasibility/Acceptability (Treatment Retention): Number of students who were retained within each of the four Adaptive Treatment Strategies
Time Frame
After Stage 2
Title
Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm
Description
General time to drop out among students who dropped out within each arm, by number of treatment sessions received
Time Frame
Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
Title
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)
Description
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.
Time Frame
Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
Title
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)
Description
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.
Time Frame
During Stage 2 (sessions 9 through 24 of treatment)
Title
Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)
Description
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).
Time Frame
End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
Title
Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)
Description
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).
Time Frame
End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
Secondary Outcome Measure Information:
Title
Scale for Suicide Ideation-Current (SSI)
Description
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.
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
Other Pre-specified Outcome Measures:
Title
The Suicide Attempt and Self-Injury Count (SASI-C)
Description
The SASI-C is a very brief interview of past self-inflicted injuries, categorized into suicide attempts and nonsuicidal acts. The SASI-C creates counts of self-inflicted injuries by method, medical risk severity, and lethality.
Time Frame
The time frame at pretreatment was both lifetime and past 2 months at baseline: and all other assessments focused on the last 2 months. This was assessed at baseline and after Stage 1 (~ 8 weeks later).
Title
The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.
Description
The CCAPS-34 is a measure of psychological distress with several sub-scales (Depression) specifically designed for college students seeking services. Depression subscale scores range from 0.1-5.0 with lower scores representing less depression
Time Frame
Baseline and End of Stage 1 interventions - 8 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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." Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Pistorello, PhD
Organizational Affiliation
University of Nevada, Reno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Counseling Services, University of Nevada, Reno
City
Reno
State/Province
Nevada
ZIP/Postal Code
89557
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
July 2018 to July 2022
IPD Sharing Access Criteria
Researcher contacts PI at pistorel@unr.edu There is justification for the use of the data and this is deemed appropriate by the PI and institution representative
IPD Sharing URL
https://scholarworks.unr.edu/
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Center for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.
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Linehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.
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Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.
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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.
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Citation
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.
Results Reference
result

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Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

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