Sleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Acceptability of Sleep Restriction Therapy
研究概览
简要总结
The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with autism spectrum disorder (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule and/or Autism Diagnostic Interview-Revised, Childhood Autism Rating Scale-2)
- •with sleep disturbances (based on clinical interview, and Sleep Disturbance Scale for Children score > 38)
- •stable pre-existing medication plans for at least 2 weeks
- •no planned changes in psychosocial and biomedical interventions during the intervention
- •an English-speaking parent able to consistently participate in study procedures
- •reside in California, USA
排除标准
- •parent or child diagnosed with severe psychiatric disorder or unstable medical problem
- •children with active seizures or epilepsy
- •primary sleep disorder is a circadian rhythm sleep-wake disorder, as determined by the sleep interview and Children's ChronoType Questionnaire.
- •current active trial of sleep restriction therapy or history of an adequate trial of sleep restriction therapy.
结局指标
主要结局
Acceptability of Sleep Restriction Therapy
时间窗: At end of treatment (approximately week 10)
Acceptability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least acceptable and 5 being the most acceptable.
Tolerability of Sleep Restriction Therapy
时间窗: At end of treatment (approximately week 10)
Tolerability will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least tolerable and 5 being the most tolerable.
Feasibility of Sleep Restriction Therapy
时间窗: At end of treatment (approximately week 10)
Feasibility will be assessed using a series of questions rated by participants on a 5-point Likert scale (1-5) with 1 being the least feasible and 5 being the most feasible.
次要结局
- Change from baseline on the Sleep Disturbance Scale for Children(Screening, Baseline, End of Week 2 Treatment, End of Treatment (approximately week 10))
- Change in sleep onset latency (Sleep-Wake Diary)(Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10))
- Change in sleep efficiency (Sleep-Wake Diary)(Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10))
- Change in wake after sleep onset duration (Sleep-Wake Diary)(Baseline, Week 1, Week 2, during 4-week follow-up period, End of Treatment (approximately week 10))
- Change in sleep onset latency (Actigraphy)(Baseline, Week 1, Week 2)
- Change in sleep efficiency (Actigraphy)(Baseline, Week 1, Week 2)
- Change in Wake After Sleep Onset (Actigraphy)(Baseline, Week 1, Week 2)
研究者
Antonio Hardan
Principal Investigator
Stanford University