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

May 7, 2024 updated by: Jeff Bridge, Nationwide Children's Hospital

A Pilot Study of Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) With Suicidal Children ("CAMS-4Kids")

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAMS-4Kids
Participants will receive up to 10 sessions of CAMS-4Kids
Behavioral: CAMS-4Kids
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAMS-4Kids Suicide Status Form-4 (SSF-4)
Time Frame: Each session measured from baseline up to 12-week follow-up
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.
Time Frame: Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
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
Time Frame: Baseline, Treatment Completion (up to 12 weeks), 3 month and 6 month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Up to 12-week follow-up
The CSQ-8 is an 8 item measure of treatment satisfaction with services with both a parent and child version.
Up to 12-week follow-up
Therapeutic Alliance Scale for Children, Revised (TASC-r)
Time Frame: Up to 12-week follow-up
The TASC-r is a measure of the working child-therapist working relationship.
Up to 12-week follow-up
Therapeutic Alliance Scale for Caregivers and Parents (TASCP)
Time Frame: Up to 12-week follow-up
The TASCP is a measure of the working caregiver-therapist working relationship.
Up to 12-week follow-up
CAMS Rating Scale
Time Frame: Each session measured from baseline up to 12-week follow-up
The CAMS Rating scale measures CAMS treatment fidelity.
Each session measured from baseline up to 12-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Collaborators

The Catholic University of America

Investigators

  • Principal Investigator: Jeffrey A Bridge, PhD, Abigail Wexner Research Institute at NCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2023

Primary Completion (Actual)

May 7, 2024

Study Completion (Actual)

May 7, 2024

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00793

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suicidal Ideation

Clinical Trials on CAMS-4Kids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe