跳至主要内容
临床试验/NCT04119648
NCT04119648终止不适用

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

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
CAMS-4Kids Suicide Status Form-4 (SSF-4)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

CAMS-4Kids Suicide Status Form-4 (SSF-4)

时间窗: 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.

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff Bridge

Director, Center for Suicide Prevention and Research

Nationwide Children's Hospital

研究点 (2)

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