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

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ClinicalTrials.gov Identifier: NCT02442869
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : September 27, 2017
Sponsor:
Collaborators:
The Catholic University of America
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Nevada, Reno

Brief Summary:
This pilot study will test 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 would allow 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. If the aims of this project are achieved, this pilot study and a subsequent large-scale trial could eventually significantly impact service delivery to suicidal college students at college counseling centers.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Treatment as usual (TAU) Behavioral: CAMS short Behavioral: CAMS long Behavioral: Dialectical Behavioral Therapy (DBT) long Not Applicable

Detailed Description:
The primary aim of this proposal is 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 will progress through two stages of intervention. In the first stage (S1) 60 participants will be 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, 2006) 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) will be 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 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 will enroll 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 are 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 rate 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Independent Evaluator was blind to condition assignment when conducting the assessments.
Primary Purpose: Treatment
Official Title: Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Actual Study Start Date : June 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Phase I TAU plus Phase II CAMS

Treatment as usual [TAU] -- treatment typically provided by counselor for 4-8 weeks

If participant is responding, treatment ends. If participant is not responding, he is then re-randomized to

Collaborative Assessment and Management of Suicidality (CAMS) long for 4-16 weeks

Behavioral: Treatment as usual (TAU)
4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.

Behavioral: CAMS long
4-16 weeks Collaborative Assessment and Management of Suicidality (CAMS) long course

Experimental: Phase I TAU plus Phase II DBT

Treatment as usual [TAU] -- treatment typically provided by counselor for 4-8 weeks

If participant is responding, treatment ends. If participant is not responding, he is then re-randomized to

Dialectical Behavioral Therapy (DBT) long for 4-16 weeks

Behavioral: Treatment as usual (TAU)
4-8 weeks of treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.

Behavioral: Dialectical Behavioral Therapy (DBT) long
4-16 weeks of Dialectical Behavioral Therapy (DBT) long course

Experimental: Phase I CAMS plus Phase II repeat CAMS

Collaborative Assessment and Management of Suicidality (CAMS) short for 4-8 weeks

If participant is responding, treatment ends. If participant is not responding, he is then re-randomized to

Collaborative Assessment and Management of Suicidality (CAMS) long for 4-16 weeks

Behavioral: CAMS short
4-8 weeks Collaborative Assessment and Management of Suicidality (CAMS) short course

Behavioral: CAMS long
4-16 weeks Collaborative Assessment and Management of Suicidality (CAMS) long course

Experimental: Phase I CAMS plus Phase II DBT

Collaborative Assessment and Management of Suicidality (CAMS) short for 4-8 weeks

If participant is responding, treatment ends. If participant is not responding, he is then re-randomized to

Dialectical Behavioral Therapy (DBT) long for 4-16 weeks

Behavioral: CAMS short
4-8 weeks Collaborative Assessment and Management of Suicidality (CAMS) short course

Behavioral: Dialectical Behavioral Therapy (DBT) long
4-16 weeks of Dialectical Behavioral Therapy (DBT) long course




Primary Outcome Measures :
  1. Feasibility/Acceptability: Number of students approached who accepted to be part of the study [ Time Frame: Baseline ]
    Participation Rate. Note for all primary outcomes: In this proposal, 'feasibility' means both the ability of the investigators to execute the SMART, and the ability to treat participants with the ATSs that comprise it (i.e., the sequence CAMS+DBT). By 'acceptability' we mean the tolerability or appropriateness of the ATSs, such as starting with CAMS and switching to DBT, and the assessment procedures that make up the ATSs being studied from both the perspective of student participants and counselors.

  2. Feasibility/Acceptability: Number of students who declined to participate in study and why [ Time Frame: Baseline ]
    Non-participation rate

  3. Feasibility/Acceptability: Number of students who were retained within each of the four AdaptiveTreatment Strategies - Change over time [ Time Frame: 24 weeks after baseline (end of Stage 2) ]
    Treatment retention

  4. Feasibility/Acceptability: General time to drop-out among students who drop-out within each arm - Change over time [ Time Frame: throughout the 24 weeks treatment will be delivered (Stage 1 and Stage 2) ]
    Time to drop-out

  5. 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 treatment will be delivered (Stage 1 and Stage 2) ]
    CAMS adherence ratings conducted by CAMS experts

  6. 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 ( week 9 through week 24 of treatment) ]
    DBT adherence ratings conducted by DBT adherence experts

  7. Feasibility/Acceptability: Satisfaction with treatment as reported by student clients via the The Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: This will be measured at end of Stage 1 (after 8 weeks of treatment), end of Stage 2 (after 24 weeks of treatment), and at 3-month Follow-up (36 weeks after baseline) ]
    Client satisfaction with treatment

  8. Feasibility/Acceptability: Satisfaction with treatment by counselors via the CSQ-8 (Therapist Version) [ Time Frame: This will be measured at end of Stage 1 (after 8 weeks of treatment), end of Stage 2 (after 24 weeks of treatment), and at 3-month Follow-up (36 weeks after baseline) ]
    Counselor satisfaction with treatment


Secondary Outcome Measures :
  1. Scale for Suicide Ideation—Current (SSI) [ Time Frame: S1 (end of Phase I interventions) -8 weeks after baseline; S2 (end of Phase II interventions) -24 weeks after baseline; and Follow-up (3 months after all treatment has ended) - 36 weeks after baseline ]
    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.


Other Outcome Measures:
  1. The Suicide Attempt and Self-Injury Count (SASI-C) [ Time Frame: The time frame at pretreatment will be both lifetime and past 2 months at baseline: and all other assessments will focus on the last 2 months. This will be assessed at baseline and through follow-up period (36 weeks after baseline). ]
    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.

  2. The Counseling Center Assessment of Psychological Symptoms (CCAPS-34). [ Time Frame: S1 (end of Phase I interventions) - 8 weeks after baseline S2 (end of Phase II interventions) -24 weeks after baseline; and Follow-up (3 months after all treatment has ended) - 36 weeks after baseline ]
    The CCAPS-34 is a measure of psychological distress with several sub-scales (e.g., anxiety, academic distress) specifically designed for college students seeking services.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • enrolled student at 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.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442869


Locations
United States, Nevada
University of Nevada, Reno, Dept. of Psychology
Reno, Nevada, United States, 89439
Sponsors and Collaborators
University of Nevada, Reno
The Catholic University of America
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jacqueline Pistorello, PhD University of Nevada, Reno

Publications:
American College Health Association (ACHA, 2012). ACHA-National College Health Assessment II: Reference group executive summary Spring 2011. Hanover MD: American College Health Association.
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.
Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.

Responsible Party: University of Nevada, Reno
ClinicalTrials.gov Identifier: NCT02442869     History of Changes
Other Study ID Numbers: 603856
R34MH104714 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: July 2018 to July 2023
Access Criteria:
  1. Researcher contacts PI at pistorel@unr.edu
  2. There is justification for the use of the data and this is deemed appropriate by the PI and institution representative
URL: https://scholarworks.unr.edu/

Keywords provided by University of Nevada, Reno:
Suicide

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms