Thinking in Speech for Children With Autism - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
研究概览
简要总结
This study examines a cognitive therapy for autistic children, Thinking in Speech. Thinking in Speech helps children with autism independently cope with everyday events that cause stress, by developing their ability to use "inner speech".
详细描述
The purpose of this study is to examine the effectiveness of Thinking in Speech (TiS) in teaching children to identify when they are experiencing a problem and learn to ask for help appropriately.
Participants. Participants will be 20 verbal children, aged 7-11, who have been diagnosed with autism or related neurocognitive disorders. Therapists will be experienced and certified speech-language pathologists (SLPs) who will be trained to use TiS For this grant, investigators will develop a standardized training program that can be administered to community SLPs. Training will consist of background reading and discussions, analysis of past therapy sessions, and practice sessions with individualized feedback provided by a trainer. Training will focus on developing the child's ability to ask for help. Asking for help requires a complex combinations of executive functions and being able to adopt the perspective of another person. Training sessions will be recorded for use in further training development and enhancements. A five-week training program is anticipated.
Procedure: Both training and therapy will be delivered remotely. The therapists will plan to conduct sixteen 30-minute remote therapy sessions over 8 weeks - the actual time frame will depend on the health and scheduling demands of the therapists and children. All TiS sessions will be video-recorded. Children will be randomly assigned to either receive therapy immediately or to be placed on a 10-week wait-list after which they will receive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Verbal language ability as reported by the caregiver
- •Ages 7-11
- •Prior autism or related neurocognitive diagnosis
- •Child proficient in English
- •Caregiver proficient in English
- •Residing in Pennsylvania
- •Access to internet at home
排除标准
- •History of major child mental illness (e.g., bipolar, schizophrenia, psychosis)
- •Child visual and/or hearing impairment that interferes with his/her ability to participate in therapy
结局指标
主要结局
Change from Baseline in Emotion Dysregulation Inventory scores to Post-Intervention
时间窗: Up to 20 weeks
This measure assesses participants' emotion dysregulation via a 30-item measure. 24 items measure reactivity and 6 items measure dysphoria. A raw score is created by summing the items for each subscale, and ranges from 0-96. Higher scores indicate greater emotion dysregulation and lower scores indicate less emotional dysregulation. Participants will be assessed using this measure at baseline and after therapy is completed.
次要结局
- Number of Thinking in Speech therapy sessions attended among all participants(Up to 20 weeks)
- Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anger Measure to Post-Intervention(Up to 20 weeks)
- Change from Baseline in Patient-Reported Outcomes Measurement Information System - Anxiety Short Form to Post-Intervention(Up to 20 weeks)
研究者
Barbara Baumann
Research Instructor in Psychiatry
University of Pittsburgh