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临床试验/NCT07603986
NCT07603986已完成不适用

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

Geha Mental Health Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

None (Open Label). Participants and research staff were not blinded to treatment allocation. Therapists were not involved in outcome measurement. Outcomes were based primarily on parent- and child-report questionnaires, with suicidality assessed by research clinicians.

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Geha Mental Health Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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