Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

NCT02442869 | Completed Results DMC

• 2 other identifiers: 603856R34MH104714
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• The Suicide Attempt and Self-Injury Count (SASI-C)

  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.

  Baseline and End of Stage 1 interventions - 8 weeks after baseline

Study Arms (4)

Stage 1 TAU plus Stage 2 CAMS

EXPERIMENTAL

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); Behavioral: Stage 2 CAMS

Stage 1 TAU plus Stage 2 DBT

EXPERIMENTAL

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); Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)

Stage 1 CAMS plus Stage 2 CAMS

EXPERIMENTAL

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; Behavioral: Stage 2 CAMS

Stage 1 CAMS plus Stage 2 DBT

EXPERIMENTAL

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; Behavioral: Stage 2 Dialectical Behavioral Therapy (DBT)

Interventions

Stage 1 Treatment as usual (TAU) BEHAVIORAL

4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.

Stage 1 TAU plus Stage 2 CAMS; Stage 1 TAU plus Stage 2 DBT

Stage 1 CAMS BEHAVIORAL

4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

Stage 1 CAMS plus Stage 2 CAMS; Stage 1 CAMS plus Stage 2 DBT

Stage 2 CAMS BEHAVIORAL

4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)

Stage 1 CAMS plus Stage 2 CAMS; Stage 1 TAU plus Stage 2 CAMS

Stage 2 Dialectical Behavioral Therapy (DBT) BEHAVIORAL

4-16 weeks of Dialectical Behavioral Therapy (DBT)

Stage 1 CAMS plus Stage 2 DBT; Stage 1 TAU plus Stage 2 DBT

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Enrolled student at the University of Nevada, Reno (UNR)
• Seeking services at Counseling Services at UNR
• 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."

You may not qualify if:

• Participant cannot have been in treatment at UNR Counseling Services within the previous 3 months.

Sponsors & Collaborators

• University of Nevada, Reno: lead
• The Catholic University of America: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Counseling Services, University of Nevada, Reno

Reno, Nevada, 89557, United States

Location

Related Publications (12)

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

  PMID: 10842426 BACKGROUND

• 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.

  PMID: 22438190 BACKGROUND

• American College Health Association (ACHA, 2012). ACHA-National College Health Assessment II: Reference group executive summary Spring 2011. Hanover MD: American College Health Association.

  BACKGROUND

• 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.

  PMID: 469082 BACKGROUND

• 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.

  PMID: 21948348 BACKGROUND

• Center for Collegiate Mental Health (CCMH, 2012). CCAPS 2012 Technical Manual. University Park, PA.

  BACKGROUND

• Jobes, D. A. (2006). Managing suicidal risk: A collaborative approach. New York: The Guilford Press.

  BACKGROUND

• Linehan, M.M. (1993). Cognitive behavioral therapy of borderline personality disorder. New York: Guilford Press.

  BACKGROUND

• 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.

  PMID: 10259963 BACKGROUND

• Linehan, M.M. (2015). DBT skills training manual (2nd ed.). New York, NY: Guilford Press.

  BACKGROUND

• 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.

  PMID: 32275480 RESULT

• 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.

  PMID: 29220633 RESULT

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

The study focused on acceptability and feasibility. Although data was collected for Stage 2 and analyzed for acceptability and feasibility outcomes (e.g., CSQ), clinical outcomes (e.g., SSI, CCAPS) were only interpreted for Stage 1 due to small sample sizes among the Stage 2 groups. A larger study is needed to identify the most effective sequence of care for suicidal risk treatments at college counseling centers.

Results Point of Contact

• Title: Dr. Jacqueline Pistorello
• Organization: University of Nevada, Reno

pistorel@unr.edu

775-784-4648

Study Officials

• Jacqueline Pistorello, PhD

  University of Nevada, Reno

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Independent Evaluator was blind to condition assignment when conducting the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 13, 2015
• Study Start: June 16, 2015
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: July 2018 to July 2022
• Access Criteria: 1. Researcher contacts PI at pistorel@unr.edu 2. There is justification for the use of the data and this is deemed appropriate by the PI and institution representative

Locations

US (1)