Overview

This trial is active, not recruiting.

Condition suicide
Treatments behavioral therapy (treatment as usual [tau]), cams short, cams long, dialectical behavioral therapy (dbt) long
Sponsor University of Nevada, Reno
Collaborator The Catholic University of America
Start date June 2015
End date December 2016
Trial size 62 participants
Trial identifier NCT02442869, 603856, R34MH104714

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 while maximizing resources in overburdened college counseling centers. If the aims of this project are achieved, this study could significantly impact service delivery to suicidal college students at college counseling centers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment as usual [TAU] Collaborative Assessment and Management of Suicidality (CAMS) long
behavioral therapy (treatment as usual [tau])
4-8 weeks of behavioral therapy
cams long
4-16 weeks Collaborative Assessment and Management of Suicidality (CAMS) long course
(Experimental)
Treatment as usual [TAU] Dialectical Behavioral Therapy (DBT) long
behavioral therapy (treatment as usual [tau])
4-8 weeks of behavioral therapy
dialectical behavioral therapy (dbt) long
4-16 weeks of Dialectical Behavioral Therapy (DBT) long course
(Experimental)
Collaborative Assessment and Management of Suicidality (CAMS) short Collaborative Assessment and Management of Suicidality (CAMS) long
cams short
4-8 weeks Collaborative Assessment and Management of Suicidality (CAMS) short course
cams long
4-16 weeks Collaborative Assessment and Management of Suicidality (CAMS) long course
(Experimental)
Collaborative Assessment and Management of Suicidality (CAMS) short Dialectical Behavioral Therapy (DBT) long
cams short
4-8 weeks Collaborative Assessment and Management of Suicidality (CAMS) short course
dialectical behavioral therapy (dbt) long
4-16 weeks of Dialectical Behavioral Therapy (DBT) long course

Primary Outcomes

Measure
Feasibility/Acceptability: Number of students approached who accepted to be part of the study
time frame: Baseline
Feasibility/Acceptability: Number of students who declined to participate in study and why
time frame: Baseline
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)
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)
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)
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)
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)
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)

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 25 years old.

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 only exclusion criterion). - participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.

Additional Information

Official title Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART
Principal investigator Jacqueline Pistorello, PhD
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 baseline risk factors and/or adjusted based on variables collected mid-treatment, 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Nevada, Reno.