Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

Not Applicable

Completed

Conditions: Suicide

Interventions: Behavioral: Stage 1 Treatment as usual (TAU)
Behavioral: Stage 1 CAMS
Behavioral: Stage 2 CAMS
Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)

Registration Number: NCT02442869

Lead Sponsor: University of Nevada, Reno

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 62

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1 TAU plus Stage 2 CAMS	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
Stage 1 TAU plus Stage 2 CAMS	Stage 1 Treatment as usual (TAU)	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
Stage 1 CAMS plus Stage 2 CAMS	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
Stage 1 TAU plus Stage 2 DBT	Stage 2 Dialectical Behavioral Therapy (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
Stage 1 CAMS plus Stage 2 DBT	Stage 2 Dialectical Behavioral Therapy (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
Stage 1 CAMS plus Stage 2 CAMS	Stage 1 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
Stage 1 TAU plus Stage 2 DBT	Stage 1 Treatment as usual (TAU)	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
Stage 1 CAMS plus Stage 2 DBT	Stage 1 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 Dialectical Behavioral Therapy (DBT) for 4-16 weeks

Primary Outcome Measures

Name	Time	Method
Feasibility/Acceptability: Number of Students Who Declined to Participate in the Study and Why	Baseline	Two typologies as to when students declined to participate emerged: Declined when approached, and Declined during the consenting process.
Feasibility/Acceptability: Fidelity of the CAMS Intervention Delivery by "Real World" CCC Counselors Via the CAMS Rating Scale 3 (CRS.3)	Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)	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: Satisfaction With Treatment as Reported by Student Participants Via the the Client Satisfaction Questionnaire (CSQ-8)	End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)	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: Participation Rate	Baseline	Number of students approached who agreed to participate in the study
Feasibility/Acceptability: Number of Students Who Were Retained Within Each of the Four Adaptive Treatment Strategies	After Stage 2	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	Throughout the 24 weeks of treatment delivery (Stage 1 and Stage 2)	General time to drop out among students who dropped out within each arm, by number of treatment sessions received
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)	During Stage 2 (sessions 9 through 24 of treatment)	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 by Counselors Via the CSQ-8 (Therapist Version)	End of Stage 1 (after 8 weeks of treatment) and end of Stage 2 (after 24 weeks of treatment)	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

Name	Time	Method
Scale for Suicide Ideation-Current (SSI)	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	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.