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

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Stage 1 Treatment as usual (TAU); Behavioral: Stage 2 CAMS; Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT); Behavioral: Stage 1 CAMS

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89557
      • Counseling Services, University of Nevada, Reno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 TAU plus Stage 2 CAMS; 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	Behavioral: 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.; Behavioral: Stage 2 CAMS; 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Experimental: Stage 1 TAU plus Stage 2 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	Behavioral: 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.; Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT); 4-16 weeks of Dialectical Behavioral Therapy (DBT)
Experimental: Stage 1 CAMS plus Stage 2 CAMS; 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	Behavioral: Stage 2 CAMS; 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS); Behavioral: Stage 1 CAMS; 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
Experimental: Stage 1 CAMS plus Stage 2 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	Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT); 4-16 weeks of Dialectical Behavioral Therapy (DBT); Behavioral: Stage 1 CAMS; 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility/Acceptability: Participation Rate	Number of students approached who agreed to participate in the study	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.	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	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	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.	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.	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).	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).	End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Suicide Attempt and Self-Injury Count (SASI-C)	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.	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).
The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.	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	Baseline and End of Stage 1 interventions - 8 weeks after baseline

Collaborators and Investigators

• Sponsor: University of Nevada, Reno
• Collaborators: National Institute of Mental Health (NIMH); The Catholic University of America
• Investigators: Principal Investigator: Jacqueline Pistorello, PhD, University of Nevada, Reno

Publications and helpful links

General Publications

• 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.
• 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.
• Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: April 16, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 603856; R34MH104714 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No