Phase 1 Study of Anger Control Therapy Augmented With RAGE-Control (Regulate and Gain Emotional-Control)Delivered on an Inpatient Psychiatric Unit
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in 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 Anger Control Therapy (ACT) with Regulate and Gain Emotional-Control (RAGE-Control) is a feasible behavioral therapy to provide on a pediatric inpatient psychiatric unit.
详细描述
Aggression and disruptive behavior are the most common reasons for child and adolescent inpatient psychiatric hospitalization. Aggressive children and adolescents who merit admission to inpatient psychiatric hospitals for treatment typically display dramatic problems with self-regulation that interfere with global adaptive functioning. The goal of this study is to teach self-regulation techniques by combining Cognitive Behavioral Therapy with a biofeedback video game in effort to motivate patients to learn and practice these coping skills, which will translate to decreased feelings of anger and aggression while hospitalized.
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
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive admissions to the psychiatric inpatient unit between the ages of 9 and 17 years of age
- •who were not expected to begin or undergo a change >25% to their antipsychotic or mood stabilizing medications
- •elevated levels of anger as demonstrated by baseline score on the State Trait Anger Expression Inventory - Child and Adolescent (STAXI-CA) combined State-anger and Trait-anger score greater than 30.
排除标准
- •Inability to consent, comprehend, and effectively participate in the study.
- •Gross cognitive impairment due to mental retardation, dementia, or intoxication.
- •Started on an antipsychotic or mood stabilizing drug within 5 days of beginning the study
结局指标
主要结局
Change from baseline in State Trait Anger Expression Inventory - Child and Adolescent
时间窗: change from baseline to just after 5th daily session of the study treatment
次要结局
- Change in Percentage of time playing videogame with heart rate under preset threshold(During videogame play at end of each of the 5 daily sessions of the study treatment)
- Therapeutic Helpfulness Questionnaire(after session number 5 of the 5 daily study treatment sessions)