Clinical trial NCT02442869: Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Official title: Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: The Catholic University of America
name: National Institute of Mental Health (NIMH)
First posted: 2015-05-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Feasibility/Acceptability: Participation Rate
timeFrame: Baseline
measure: Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why
timeFrame: Baseline
measure: Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies
timeFrame: After Stage 2
measure: Feasibility/Acceptability: General Time to Drop-out Among Students Who Dropped Out Within Each Arm
timeFrame: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
measure: Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)
timeFrame: Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)
measure: 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)
timeFrame: During Stage 2 (sessions 9 through 24 of treatment)
measure: Feasibility/Acceptability: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
measure: Feasibility/Acceptability: Satisfaction With Treatment by Counselors Via the CSQ-8 (Therapist Version)
timeFrame: End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)
Secondary outcomes:
measure: Scale for Suicide Ideation-Current (SSI)
timeFrame: 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 outcomes:
measure: The Suicide Attempt and Self-Injury Count (SASI-C)
timeFrame: 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).
measure: The Counseling Center Assessment of Psychological Symptoms (CCAPS-34) Depression Scale.
timeFrame: Baseline and End of Stage 1 interventions - 8 weeks after baseline
Locations:
city: Reno
country: United States
facility: Counseling Services, University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Jacqueline Pistorello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Center for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.
citation: Jobes, D. A. (2006). Managing suicidal risk: A collaborative approach. New York: The Guilford Press.
citation: Linehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.
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citation: Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.
citation: 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.
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.