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

Primary Purpose

Suicidal Ideation, Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAMS-4Kids
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Suicide, Child, CAMS

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nationwide Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAMS-4Kids

Arm Description

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

Outcomes

Primary Outcome Measures

CAMS-4Kids Suicide Status Form-4 (SSF-4)
The SSF-4 measures overall suicide risk.
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.
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.

Secondary Outcome Measures

Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is an 8 item measure of treatment satisfaction with services with both a parent and child version.
Therapeutic Alliance Scale for Children, Revised (TASC-r)
The TASC-r is a measure of the working child-therapist working relationship.
Therapeutic Alliance Scale for Caregivers and Parents (TASCP)
The TASCP is a measure of the working caregiver-therapist working relationship.
CAMS Rating Scale
The CAMS Rating scale measures CAMS treatment fidelity.

Full Information

First Posted
October 7, 2019
Last Updated
September 15, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
The Catholic University of America
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1. Study Identification

Unique Protocol Identification Number
NCT04119648
Brief Title
A Pilot Study of Collaborative Assessment and Management of Suicidality With Suicidal Children ("CAMS-4Kids")
Acronym
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
The Catholic University of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Attempted
Keywords
Suicide, Child, CAMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is an open pilot trial of one treatment without control or comparison group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAMS-4Kids
Arm Type
Experimental
Arm Description
Participants will receive up to 10 sessions of CAMS-4Kids
Intervention Type
Behavioral
Intervention Name(s)
CAMS-4Kids
Intervention 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.
Primary Outcome Measure Information:
Title
CAMS-4Kids Suicide Status Form-4 (SSF-4)
Description
The SSF-4 measures overall suicide risk.
Time Frame
Each session measured from baseline up to 12-week follow-up
Title
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.
Description
The CIS is a valid 13-item child- and parent- report measure of psychosocial impairment with good internal consistency and test-retest reliability.
Time Frame
Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
Title
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
Description
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.
Time Frame
Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
Secondary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
The CSQ-8 is an 8 item measure of treatment satisfaction with services with both a parent and child version.
Time Frame
Up to 12-week follow-up
Title
Therapeutic Alliance Scale for Children, Revised (TASC-r)
Description
The TASC-r is a measure of the working child-therapist working relationship.
Time Frame
Up to 12-week follow-up
Title
Therapeutic Alliance Scale for Caregivers and Parents (TASCP)
Description
The TASCP is a measure of the working caregiver-therapist working relationship.
Time Frame
Up to 12-week follow-up
Title
CAMS Rating Scale
Description
The CAMS Rating scale measures CAMS treatment fidelity.
Time Frame
Each session measured from baseline up to 12-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey A Bridge, PhD
Phone
614-722-3081
Email
jeff.bridge@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jaclyn L Tissue, MSW
Phone
614-355-1529
Email
jaclyn.tissue@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Bridge, PhD
Organizational Affiliation
Abigail Wexner Research Institute at NCH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Bridge, PhD
Phone
614-722-3081
Email
jeff.bridge@nationwidechildrens.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Jobes, D. A. (2016). Managing suicidal risk: A collaborative approach 2nd Ed. New York: Guilford Press.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
21948348
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.
Results Reference
background
PubMed Identifier
22369081
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.
Results Reference
background
PubMed Identifier
25581595
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.
Results Reference
background
PubMed Identifier
28126581
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.
Results Reference
background
PubMed Identifier
16268766
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.
Results Reference
background
PubMed Identifier
30771641
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.
Results Reference
background
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.
Results Reference
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A Pilot Study of Collaborative Assessment and Management of Suicidality With Suicidal Children ("CAMS-4Kids")

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