A Pilot Study of Collaborative Assessment and Management of Suicidality With Suicidal Children ("CAMS-4Kids")

NCT04119648 | Terminated

• 1 other identifier: 00793
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide, Attempted

Keywords

Suicide; Child; CAMS

Outcome Measures

Primary Outcomes (3)

• CAMS-4Kids Suicide Status Form-4 (SSF-4)

  The SSF-4 measures overall suicide risk.

  Each session measured from baseline up to 12-week follow-up

• 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.

  The CIS is a valid 13-item child- and parent- report measure of psychosocial impairment with good internal consistency and test-retest reliability. Scores range from 0 (no problem) to 4 (very bad problem), with higher scores indicating worse outcomes.

  Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up

• 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

  The C-SSRS is a validated, semi-structured interview that assesses both suicidal behavior and suicidal ideation (yes/no, frequency), with flexible timepoints and multiple informants depending on administrator purpose and need. Scores range 0 (no ideation) to 5 (ideation with plan and intent), with higher numbers indicating worse outcomes. Suicidal behavior is present or absent, presence of behavior indicates worse outcomes.

  Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up

Secondary Outcomes (4)

• Client Satisfaction Questionnaire (CSQ-8)

  Up to 12-week follow-up

• Therapeutic Alliance Scale for Children, Revised (TASC-r)

  Up to 12-week follow-up

• Therapeutic Alliance Scale for Caregivers and Parents (TASCP)

  Up to 12-week follow-up

• CAMS Rating Scale

  Each session measured from baseline up to 12-week follow-up

Study Arms (1)

CAMS-4Kids

EXPERIMENTAL

Participants will receive up to 10 sessions of CAMS-4Kids

Behavioral: CAMS-4Kids

Interventions

CAMS-4Kids BEHAVIORAL

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.

CAMS-4Kids

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• The Catholic University of America: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (9)

• Jobes, D. A. (2016). Managing suicidal risk: A collaborative approach 2nd Ed. New York: Guilford Press.

  BACKGROUND

• Anderson, A. R., Keyes, G. M. & Jobes, D. A. (2016). Understanding and treating suicidal risk in young children. Practice Innovations, 1(1), 3-19.

  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

• 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.

  PMID: 22369081 BACKGROUND

• 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.

  PMID: 25581595 BACKGROUND

• 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.

  PMID: 28126581 BACKGROUND

• 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.

  PMID: 16268766 BACKGROUND

• 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.

  PMID: 30771641 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jeffrey A Bridge, PhD

  Abigail Wexner Research Institute at NCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Suicide Prevention and Research

Model Details: This study is an open pilot trial of one treatment without control or comparison group.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: March 17, 2023
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)