Suicidal Ideation Clinical Trial
— CAMS-4KidsOfficial title:
A Pilot Study of Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) With Suicidal Children ("CAMS-4Kids")
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 |
Verified date | May 2024 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Nationwide Children's Hospital | The Catholic University of America |
United States,
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
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 |
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