Developing Adaptive Interventions for Suicidal College Students Seeking Treatment - SMART

NCT ID: NCT02442869

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-16
• Study Completion Date: 2016-12-30

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.

Conditions

Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stage 1 TAU plus 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

Group Type: EXPERIMENTAL

Stage 1 Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

Stage 2 CAMS

Intervention Type: BEHAVIORAL

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

Stage 1 TAU plus Stage 2 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

Group Type: EXPERIMENTAL

Stage 1 Treatment as usual (TAU)

Intervention Type: BEHAVIORAL

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

Stage 2 Dialectical Behavioral Therapy (DBT)

Intervention Type: BEHAVIORAL

4-16 weeks of Dialectical Behavioral Therapy (DBT)

Stage 1 CAMS plus 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

Group Type: EXPERIMENTAL

Stage 1 CAMS

Intervention Type: BEHAVIORAL

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

Stage 2 CAMS

Intervention Type: BEHAVIORAL

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

Stage 1 CAMS plus Stage 2 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

Group Type: EXPERIMENTAL

Stage 1 CAMS

Intervention Type: BEHAVIORAL

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

Stage 2 Dialectical Behavioral Therapy (DBT)

Intervention Type: BEHAVIORAL

4-16 weeks of Dialectical Behavioral Therapy (DBT)

Interventions

Stage 1 Treatment as usual (TAU)

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

Intervention Type: BEHAVIORAL

Stage 1 CAMS

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

Intervention Type: BEHAVIORAL

Stage 2 CAMS

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

Intervention Type: BEHAVIORAL

Stage 2 Dialectical Behavioral Therapy (DBT)

4-16 weeks of Dialectical Behavioral Therapy (DBT)

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of America

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Nevada, Reno

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline Pistorello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Reno

Locations

Counseling Services, University of Nevada, Reno

Reno, Nevada, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 10842426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22438190 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 469082 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21948348 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10259963 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 32275480 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29220633 (View on PubMed)

Other Identifiers

R34MH104714

Identifier Type: NIH

Identifier Source: secondary_id

View Link

603856

Identifier Type: -

Identifier Source: org_study_id