Clinical trial NCT04119648: A Pilot Study of Collaborative Assessment and Management of Suicidality With Suicidal Children ("CAMS-4Kids")
Official title: A Pilot Study of Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) With Suicidal Children ("CAMS-4Kids")
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Keywords: Suicide
Child
CAMS
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of America
First posted: 2019-10-08
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is an open pilot trial of one treatment without control or comparison group.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the feasibility and acceptability of CAMS-4Kids for children with suicidal ideation and/or behavior. During this open pilot trial, we will enhance treatment procedures, refine adherence measures, and develop a treatment manual. Our study sample will include 10 children, ages 5 - 11 years old, seeking outpatient services for suicidal ideation and/or behavior.

Detailed description: The Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) is an evidence-based, therapeutic framework for addressing suicide risk in the adult population. CAMS-4Kids, the research intervention used in this study, is a 10-session developmentally-sensitive adaptation of CAMS for children ages 5 - 11 years old.

Within the CAMS framework, clinicians treat patient-identified issues that contribute to their suicidal thoughts and/or behavior called "suicidal drivers." A "clinical road map" is provided through the Suicide Status Form (SSF) that guides treatment as an assessment, treatment planning, tracking and clinical outcome tool. Clinicians and children engage in the assessment and treatment planning sections of the SSF - Initial Form at the outset of treatment. A CAMS Stabilization Plan is also collaboratively developed which focuses on reducing access to lethal means, coping strategies, decreasing interpersonal isolation, and ways to address potential barriers to care.

Subsequent CAMS-4Kids sessions include ongoing assessment and treatment plan reviews using the SSF - Interim Sessions Form. The CAMS Stabilization Plan is also reviewed and updated as clinically indicated. Treatment involves clinical interventions most appropriate to treat the patient's "suicidal drivers." Clinical interventions may include coping cards, "Hope Journal," behavioral activation, Virtual Hope Box, increasing social support, guided imagery, DBT relaxation skills, positive self-talk, and other cognitive-behavioral techniques.

The conclusion of CAMS-4Kids occurs after 3 consecutive sessions of effectively managing suicidal ideation and behavior. The SSF Outcome/Dispositional Final Session Form is completed at the end of treatment.

Eligibility criteria: Inclusion Criteria:

* children between the ages of 5 - 11 years old, inclusive, at the time of consent;
* current suicidal ideation and/or behavior;
* resides with primary caregiver who has legal authority to consent to research participation
* client of outpatient Behavioral Health Services
* Outpatient or Mood and Anxiety Program visit scheduled at least 4 weeks from the diagnostic assessment and/or discharge from the Crisis Stabilization Unit.

Exclusion Criteria:

* the inability to understand study procedures (e.g. developmental disabilities, severe cognitive impairments, actively psychotic)
* inability of the child and/or parent to speak or read English
* current participation in weekly therapy sessions with outpatient Behavioral Health Crisis Team

Primary outcomes:
measure: CAMS-4Kids Suicide Status Form-4 (SSF-4)
timeFrame: Each session measured from baseline up to 12-week follow-up
measure: Change from baseline in psychosocial functioning and impairment on the Columbia Impairment Scale (CIS) at treatment completion (up to 12 weeks), 3 months and 6 months.
timeFrame: Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
measure: Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at treatment completion (up to 12 weeks) 3 months and 6 months
timeFrame: Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
Secondary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Up to 12-week follow-up
measure: Therapeutic Alliance Scale for Children, Revised (TASC-r)
timeFrame: Up to 12-week follow-up
measure: Therapeutic Alliance Scale for Caregivers and Parents (TASCP)
timeFrame: Up to 12-week follow-up
measure: CAMS Rating Scale
timeFrame: Each session measured from baseline up to 12-week follow-up
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at NCH
name: Jeffrey A Bridge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jobes, D. A. (2016). Managing suicidal risk: A collaborative approach 2nd Ed. New York: Guilford Press.
citation: Anderson, A. R., Keyes, G. M. & Jobes, D. A. (2016). Understanding and treating suicidal risk in young children. Practice Innovations, 1(1), 3-19.
citation: 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.
citation: Ellis TE, Green KL, Allen JG, Jobes DA, Nadorff MR. Collaborative assessment and management of suicidality in an inpatient setting: results of a pilot study. Psychotherapy (Chic). 2012 Mar;49(1):72-80. doi: 10.1037/a0026746.
citation: Ellis TE, Rufino KA, Allen JG, Fowler JC, Jobes DA. Impact of a Suicide-Specific Intervention within Inpatient Psychiatric Care: The Collaborative Assessment and Management of Suicidality. Suicide Life Threat Behav. 2015 Oct;45(5):556-566. doi: 10.1111/sltb.12151. Epub 2015 Jan 12.
citation: Ellis TE, Rufino KA, Allen JG. A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. Psychiatry Res. 2017 Mar;249:252-260. doi: 10.1016/j.psychres.2017.01.032. Epub 2017 Jan 14.
citation: Jobes DA, Wong SA, Conrad AK, Drozd JF, Neal-Walden T. The collaborative assessment and management of suicidality versus treatment as usual: a retrospective study with suicidal outpatients. Suicide Life Threat Behav. 2005 Oct;35(5):483-97. doi: 10.1521/suli.2005.35.5.483.
citation: Ryberg W, Zahl PH, Diep LM, Landro NI, Fosse R. Managing suicidality within specialized care: A randomized controlled trial. J Affect Disord. 2019 Apr 15;249:112-120. doi: 10.1016/j.jad.2019.02.022. Epub 2019 Feb 7.
citation: O'Connor, S. S., Brausch, A. M., Anderson, A. R., & Jobes, D. A. (2014). Applying the Collaborative Assessment and Management of Suicidality (CAMS) to suicidal adolescents. International Journal of Behavioral Consultation and Therapy, 9(3), 53-58.