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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119648
Recruitment Status : Not yet recruiting
First Posted : October 8, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
The Catholic University of America
Information provided by (Responsible Party):
Jeff Bridge, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Suicide, Attempted Behavioral: CAMS-4Kids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study is an open pilot trial of one treatment without control or comparison group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) With Suicidal Children ("CAMS-4Kids")
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. 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.

  2. Columbia Impairment Scale (CIS) [ Time Frame: Baseline and up to 12-week follow-up ]
    The CIS is a widely used measure of functional impairment.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. CAMS Rating Scale [ Time Frame: Each session measured from baseline up to 12-week follow-up ]
    The CAMS Rating scale measures CAMS treatment fidelity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119648


Contacts
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Contact: Jeffrey A Bridge, PhD 614-722-3081 jeff.bridge@nationwidechildrens.org
Contact: Sandra M McBee-Strayer, PhD 614-355-3596 sandy.mcbee-strayer@nationwidechildrens.org

Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Contact: Jeffrey A Bridge, PhD    614-722-3081    jeff.bridge@nationwidechildrens.org   
Sponsors and Collaborators
Nationwide Children's Hospital
The Catholic University of America
Investigators
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Principal Investigator: Jeffrey A Bridge, PhD Abigail Wexner Research Institute at NCH
Publications:
Jobes, D. A. (2016). Managing suicidal risk: A collaborative approach 2nd Ed. New York: Guilford Press.
Anderson, A. R., Keyes, G. M. & Jobes, D. A. (2016). Understanding and treating suicidal risk in young children. Practice Innovations, 1(1), 3-19.
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.

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Responsible Party: Jeff Bridge, Director, Center for Suicide Prevention and Research, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT04119648    
Other Study ID Numbers: 00793
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeff Bridge, Nationwide Children's Hospital:
Suicide
Child
CAMS
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms