Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04119648
Other study ID # 00793
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 17, 2023
Est. completion date May 7, 2024

Study information

Verified date May 2024
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date May 7, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Nationwide Children's Hospital The Catholic University of America

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. Up to 12-week follow-up
Secondary Therapeutic Alliance Scale for Children, Revised (TASC-r) The TASC-r is a measure of the working child-therapist working relationship. Up to 12-week follow-up
Secondary Therapeutic Alliance Scale for Caregivers and Parents (TASCP) The TASCP is a measure of the working caregiver-therapist working relationship. Up to 12-week follow-up
Secondary CAMS Rating Scale The CAMS Rating scale measures CAMS treatment fidelity. Each session measured from baseline up to 12-week follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT05334381 - Navigating Mental Health Treatment for Black Youth N/A
Recruiting NCT04653337 - Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression Phase 2
Terminated NCT04254809 - Evaluation of a Computerized Intervention for Learning to Re-Evaluate Suicidal Thoughts N/A
Recruiting NCT05848089 - Real-time Intervention for Suicide Risk Reduction N/A
Recruiting NCT06322199 - Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3
Completed NCT05280756 - Home-based tDCS for Prevention of Suicidal Ideation N/A
Not yet recruiting NCT06454136 - Pilot Trial of Mobile Technology for Adolescent Suicidality N/A
Completed NCT01944293 - Ketamine for Suicidality in Bipolar Depression Phase 1/Phase 2
Completed NCT02021344 - Mental Health First Aid for College Students N/A
Not yet recruiting NCT04686162 - Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal Behavior: Study of Acceptability and Preliminary Results of Efficacy N/A
Recruiting NCT05377177 - Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI N/A
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT05925322 - Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality N/A
Not yet recruiting NCT05427734 - Treating Drivers of Suicide Using Jaspr Health N/A
Recruiting NCT04112368 - Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach Phase 4
Completed NCT04026308 - Written vs Electronic Safety Planning Study N/A
Recruiting NCT05537376 - A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness N/A
Not yet recruiting NCT06311591 - Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B N/A
Recruiting NCT05894980 - How to Reduce Suicidal Thoughts and Impulsivity in Depression N/A
Not yet recruiting NCT05860257 - Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction N/A