Evaluating Intensive Group Behavioral Treatment for Children With Selective Mutism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Clinical Global Impressions Scales - Improvement (CGI-I)
研究概览
简要总结
This goal of this study is to evaluate an intensive group behavioral treatment (IGBT) program for children with selective mutism, a low base-rate childhood anxiety disorder. 29 children between the ages of 5 and 9 will be randomly assigned to participate in a 5-day IGBT over the summer or to a waitlist control condition, with the opportunity to participate in IGBT 4 weeks later. All children that participate in treatment will be followed up 8 weeks into the following school year.
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)
盲法说明
"Independent evaluators" assigned to assess outcomes will be masked to whether or not families participated in IGBT or were at the end of their waitlist period.
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets diagnostic criteria for selective mutism
- •Verbal with at least 1 parent or caregiver
- •Child fluent in English
排除标准
- •Any mental health difficulty significantly more impairing than selective mutism
研究组 & 干预措施
Treatment
The treatment consists of a 5-day intensive group behavioral treatment program (IGBT)
干预措施: Intensive Group Behavioral Treatment (IGBT) (Behavioral)
Waitlist
The waitlist consists of a 4-week waitlist period where parents will be provided with psychoeducational materials about their child's condition (i.e., selective mutism). After the 4-week waitlist period, families will be provided with the opportunity to participate in IGBT.
结局指标
主要结局
Clinical Global Impressions Scales - Improvement (CGI-I)
时间窗: 5 minutes
CGI-I is the most widely used clinician-rated measure of treatment-related changes in functioning (Guy \& Bonato, 1970) and will be completed by masked independent evaluators in the present study. The CGI-I rates clinical improvement on a 7-point scale, ranging from 1 ("very much improved") to 7 ("very much worse").
次要结局
- Anxiety Disorders Interview Schedule for Children (ADIS)(2 hours)
- Child Behavior Checklist (CBCL)(30 minutes)
- School Speech Questionnaire (SSQ)(5 minutes)
- Selective Mutism Questionnaire (SMQ)(10 minutes)
- Children's Global Assessment Scale (CGAS)(5 minutes)
- Impairment Rating Scale (IRS)(8 minutes)