Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Stage 1 Treatment as usual (TAU)
* Behavioral: Stage 1 CAMS
* Behavioral: Stage 2 CAMS
* Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1 TAU plus Stage 2 CAMS<br>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)<br>* 4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.<br>Behavioral: Stage 2 CAMS<br>* 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)<br>|
| Experimental: Stage 1 TAU plus Stage 2 DBT<br>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)<br>* 4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.<br>Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)<br>* 4-16 weeks of Dialectical Behavioral Therapy (DBT)<br>|
| Experimental: Stage 1 CAMS plus Stage 2 CAMS<br>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 1 CAMS<br>* 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)<br>Behavioral: Stage 2 CAMS<br>* 4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)<br>|
| Experimental: Stage 1 CAMS plus Stage 2 DBT<br>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 1 CAMS<br>* 4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)<br>Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)<br>* 4-16 weeks of Dialectical Behavioral Therapy (DBT)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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