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Clinical Trials/NCT04119648
NCT04119648TerminatedNot Applicable

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

Nationwide Children's Hospital1 site in 1 country3 target enrollmentStarted: March 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
CAMS-4Kids Suicide Status Form-4 (SSF-4)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CAMS-4Kids

Experimental

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

Intervention: CAMS-4Kids (Behavioral)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Therapeutic Alliance Scale for Caregivers and Parents (TASCP)(Up to 12-week follow-up)
  • 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)
  • CAMS Rating Scale(Each session measured from baseline up to 12-week follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeff Bridge

Director, Center for Suicide Prevention and Research

Nationwide Children's Hospital

Study Sites (1)

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