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CBT for Anger and Aggression in Children: a Pilot Study of Irritability and Suicidality

2026年5月17日 更新者:Geha Mental Health Center

CBT for Anger and Aggression in Children: A Pilot Study of Irritability and Suicidality

This pilot study evaluated whether cognitive behavioral therapy for anger and aggression, added to treatment as usual, was associated with reductions in irritability and suicidal ideation in preteen children with externalizing disorders. Children aged 8 to 12 years who were referred to an outpatient child psychiatry clinic for irritability, anger outbursts, or reactive aggression were assigned to CBT-AA plus treatment as usual or treatment as usual alone. The intervention included individual child sessions focused on emotion regulation, problem-solving, and social skills, with parent guidance sessions. Irritability and suicidal ideation were assessed at baseline, during treatment, at the end of treatment, and at follow-up.

研究概览

详细说明

This was a partially randomized, pragmatic pilot study conducted in a child psychiatric outpatient clinic at Geha Mental Health Center in Israel. The study included children aged 8 to 12 years with externalizing disorders, including ADHD, oppositional defiant disorder, intermittent explosive disorder, disruptive mood dysregulation disorder, or conduct disorder, who were referred because of clinically significant irritability and/or reactive aggression.

Participants were assigned to cognitive behavioral therapy for anger and aggression plus treatment as usual or to treatment as usual alone. During the initial treatment cycle, allocation was conducted using a computerized randomization procedure with sequentially numbered, sealed opaque envelopes and stratification by recent suicidal ideation or suicidal behavior. In later treatment cycles, assignment was constrained by therapist availability and scheduling within the outpatient service. For these later assignments, participants were allocated according to treatment capacity and order of referral rather than by participant clinical characteristics.

CBT-AA was delivered as an individual, in-person, protocol-based treatment. The intervention focused on three main domains: emotion regulation, social problem-solving, and social skills. Treatment as usual consisted of routine psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.

The primary outcome was irritability, assessed with the Irritability and Dysregulation of Emotions Questionnaire-13 and the Affective Reactivity Index. Secondary outcomes included suicidal ideation and suicidal behavior assessed using the Columbia-Suicide Severity Rating Scale. Assessments were conducted at baseline, after treatment modules, at the end of treatment, and during follow-up.

The study was approved by the Institutional Helsinki Committee of Geha Mental Health Center. This record is being submitted retrospectively.

研究类型

介入性

注册 (实际的)

46

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Petah Tikva、以色列、49100
        • Geha Mental Health Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • Child age 8 to 12 years
  • Parent or guardian able to read and write in Hebrew
  • Receiving care in the Geha outpatient child and adolescent clinics
  • Clinical diagnosis of ADHD, oppositional defiant disorder, intermittent explosive disorder, disruptive mood dysregulation disorder, or conduct disorder
  • Irritability and/or reactive aggression as the reason for treatment seeking

Exclusion Criteria:

  • Psychotic disorder or bipolar disorder
  • Substance use
  • Autism spectrum disorder
  • IQ score less than 75 or clinical diagnosis of intellectual disability
  • Immediate suicide risk requiring hospitalization as determined by the referring clinician

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Cognitive Behavioral Therapy for Anger and Aggression (CBT-AA) Plus Treatment as Usual (TAU)
Participants received cognitive behavioral therapy for anger and aggression in addition to treatment as usual.
Protocol-based individual cognitive behavioral therapy for anger and aggression delivered in person in an outpatient child psychiatry clinic. The intervention included three treatment modules: emotion regulation, social problem-solving, and social skills. The emotion regulation module focused on recognizing anger triggers, monitoring emotional intensity, labeling emotions, identifying bodily signs of anger, and using strategies to reduce physiological arousal. The social problem-solving module focused on interpreting social cues, considering other perspectives, generating alternative responses, and managing the effect of anger on thinking and decision-making. The social skills module focused on assertiveness, prosocial responses to interpersonal conflict, role-play, guided practice, and generalization of skills to daily situations. Parent guidance sessions were included, and parents were briefed by therapists during the treatment process. The intervention was delivered in addition to t
其他名称:
  • CBT-AA
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
其他名称:
  • 塔乌
有源比较器:Treatment as Usual (TAU)
Participants received treatment as usual alone, including routine psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
Routine outpatient psychiatric care, including psychiatric consultation, pharmacological treatment when indicated, and non-behavioral psychosocial interventions available through the clinic.
其他名称:
  • 塔乌

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Parent-Reported Irritability Measured by the Irritability and Dysregulation of Emotions Questionnaire-13
大体时间:Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Irritability was assessed using the Irritability and Dysregulation of Emotions Questionnaire-13. Parent-report and child-report versions were administered. Items are rated on a 7-point Likert scale from -3 to +3, and summary scores were calculated as the mean of completed items. Higher scores indicate greater irritability.
Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.

次要结果测量

结果测量
措施说明
大体时间
Change in Irritability Measured by the Affective Reactivity Index
大体时间:Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Irritability was assessed using the Affective Reactivity Index. Parent-report and child-report versions were administered. Items are rated on a 3-point Likert scale, and summary scores were calculated as the mean of completed items. Higher scores indicate greater irritability.
Baseline; end of treatment, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Change in Suicidal Ideation Severity Measured by the Columbia-Suicide Severity Rating Scale
大体时间:Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Suicidal ideation severity was assessed for the relevant C-SSRS reference period at each assessment. The primary suicidal ideation analysis used baseline, end of treatment, 1-month follow-up, and 3-month follow-up assessments.
Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Occurrence of Suicidal Behavior Measured by the Columbia-Suicide Severity Rating Scale
大体时间:Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.
Suicidal behavior was assessed using the Columbia-Suicide Severity Rating Scale. Suicidal behavior was coded as present if a suicide attempt, interrupted attempt, or aborted attempt was reported by either the parent or the child during the assessment period.
Baseline; end of Module 1, approximately Weeks 6 to 9; end of Module 2, approximately Weeks 10 to 15; end of Module 3/treatment completion, approximately Weeks 16 to 23; 1 month after treatment completion; and 3 months after treatment completion.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tomer Levy, MD、Geha Mental Health Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月22日

初级完成 (实际的)

2024年8月4日

研究完成 (实际的)

2025年2月10日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual participant data that underlie the published results may be made available upon reasonable request to the corresponding author, subject to approval by the study investigators and applicable institutional and ethics requirements. Data will not be publicly posted because the dataset includes sensitive pediatric mental health and suicidality information.

IPD 共享时间框架

Beginning 6 months after publication and available for 5 years.

IPD 共享访问标准

De-identified individual participant data underlying the published results and analytic code may be made available to qualified researchers upon reasonable request to the corresponding author. Requests should include a methodologically sound proposal and will be reviewed by the study investigators. Data sharing will be subject to applicable institutional approval, ethics requirements, and a data use agreement. Data will not be publicly posted because they include sensitive pediatric mental health and suicidality information.

IPD 共享支持信息类型

  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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