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临床试验/NCT01551732
NCT01551732Unknown不适用

Anger Control Therapy (ACT) With RAGE-Control: An Outpatient Videogame-assisted Therapy for the Treatment of Anger

Gonzalez-Heydrich, Joseph, M.D.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年8月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
State Trait Anger Expression Inventory - Child and Adolescent

研究概览

简要总结

The purpose of this study is to determine whether adding an interactive biofeedback video game to anger control cognitive behavioral therapy is an effective and feasible treatment.

详细描述

Current treatments for pathological anger and aggression in youth are lacking in their effectiveness to motivate and engage patients in treatment. As a result, mental health providers encounter challenges due to the limited generalizability of treatment effects to real-world situations outside of the therapist's office. When behavioral treatments fail to show lasting results, children and adolescents are often placed on antipsychotic medication to control their behaviors, which may result in significant toxicity levels and for which there is limited knowledge of the long-term effects on pediatric growth and development. This study tests an interactive biofeedback video game called RAGE-Control (for Regulate and Gain Emotional-Control) as a treatment for youth exhibiting anger and aggression. Treatment with RAGE-Control seeks to motivate children and adolescents to learn and practice coping skills taught in therapy within the environment of a fun and enjoyable video game. The game provides patients a venue to practice self-regulation techniques in response to the increasing stress of the game. Providing patients with the opportunity to refine their self-regulation skills in a fast-paced challenging game is hypothesized to result in greater generalization of therapeutic skills to situations outside of the therapist's office. The goal of the treatment is to decrease patients' feelings of anger, and to increase the patients' levels of control in their emotional and behavioral responses.

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
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages 10 to17 years old (inclusive).
  • STAXI-CA score >15 on the Trait Anger subscales.

排除标准

  • Inability to consent, comprehend, or effectively participate in the study.
  • Cognitive impairment, defined as IQ <
  • Change in mood stabilizing and/or anti-psychotic medication dose within 4 weeks of beginning the study or anticipation of medication changes during the study period (10 weeks).

结局指标

主要结局

State Trait Anger Expression Inventory - Child and Adolescent

时间窗: Baseline and two weeks Post treatment

This is a 35 item self-report measure of patients' subjective feelings of anger and aggression administered at the baseline assessment prior to the first session and again two weeks post treatment.

次要结局

  • Disruptive Behavior Disorder Rating Scale (DBDRS)(Baseline and two weeks post treatment)

研究者

发起方
Gonzalez-Heydrich, Joseph, M.D.
申办方类型
Indiv
责任方
Sponsor

研究点 (2)

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