Development and Validation of a Comprehensive Module for Management of Sleep Disorders in Children With Autism Spectrum Disorder Aged 4-10 Years: a Pre and Post Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- To validate the above module in children of ASD with sleep disorders by comparing change in sleep onset latency
研究概览
简要总结
Sleep disorder in autism children is common and it affects the physical, behavior and mental health. There is lack of comprehensive management program/module to treat the sleep disorders in children with ASD. Limited studies evaluating the utility of actigraphy to diagnose sleep disorders in ASD and its validation with PSG are present. Rationale of this study is to develop the comprehensive module and validate it for children with autism spectrum disorders, so as to improve the behavioral outcomes as well. This study also helps to utilize actigraphy as a modality to diagnose sleep disorders in children with autism spectrum disorder as performing PSG in these children is cumbersome and difficult as ASD children tend to have sensory abnormalities.
详细描述
Development of module for management of sleep disorders in children with ASD will be done by Delphi method:
Proposed components of Module include
Behavioral intervention
- Modifying stimulus by change in location of sleep onset, using bedtime stories.
- Giving schedules to activities which interfere with sleep before bedtime itself so they don't disturb the sleep onset now .
- Using a bedtime pass which allows children to make a predetermined number of requests for parental attention while in bed.
- Giving sleep items like cuddle toys to replace the parental presence
- Delaying the bedtime so the child feels urge to sleep and slowly decreasing that time
- Sleep hygiene by providing suitable environment for child to sleep, providing proper bedtime routine, sleep wake schedules
- Providing rewards for children who followed the good bedtime routine as positive reinforcement.
Pharmacological 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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4-10 years with diagnosis of ASD and ICSD based sleep disorder
- •At-least 6 months of behavioral therapy and follow-up at AIIMS
排除标准
- •Refractory epilepsy
- •Secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis
- •ASD with metabolic disorders
研究组 & 干预措施
Children [4-10 years] with ASD with sleep disorder
Development of module by Delphi method:components of Module include Behavioural intervention Modifying stimulus by change in location,using bedtime stories. Giving schedules to activities which interfere with sleep before bedtime. Using a bedtime pass to allow child to make a prefixed number of requests for parental attention while in bed.
Giving sleep items like cuddle toys to replace parental presence. Gradually delaying the bedtime so the child feels urge to sleep. Sleep hygiene by providing suitable environment to sleep, proper bedtime routine, sleep wake schedules Providing rewards for following good bedtime routine as positive reinforcement. Pharmacological intervention Sleep disorders due to underlying ENT, pulmonary conditions, to be treated as per standard protocol Usage of melatonin if required for sleep onset difficulty An 80%agreement over an intervention will be included in the module
干预措施: Comprehensive module for management of sleep disorders[Behavioral and pharmacological therapy] (Behavioral)
结局指标
主要结局
To validate the above module in children of ASD with sleep disorders by comparing change in sleep onset latency
时间窗: From baseline to 6 months
Change in sleep onset latency(time duration)as measured by PSG and actigraphy pre and post intervention.
To validate the above module in children of ASD with sleep disorders by measuring change in Children's Sleep Habits Questionnaire(CSHQ) score pre and post intervention.
时间窗: From baseline to 6 months
The CSHQ is a parent-rated questionnaire comprised of 45 items; 33 scored questions, and 7 additional items intended to provide other relevant information pertaining to sleep behavior (e.g., nocturnal body pains) Each scored question is rated on a 3-point scale as occurring "usually" (i.e., 5-7 times within the past week), "sometimes" (i.e., 2-4 times within the past week), or "rarely" (i.e., never or 1 time within the past week). A number of items on the questionnaire are reverse-scored, so that higher scores consistently indicate problem behaviors. Ratings are combined to form eight subscales: Bedtime Resistance, Sleep Onset Delay, Sleep Duration, Sleep Anxiety, Night Wakings, Parasomnias, Sleep Disordered Breathing, and Daytime Sleepiness. A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99.
Development of comprehensive module for management of sleep disorders in autism spectrum disorders
时间窗: 3 months from onset of study
The comprehensive module will be developed for management of sleep disorders. The proposed components in the module are Behavioral intervention like modifying stimulus by change in location of sleep onset,Giving schedule activities which interfere with sleep before bedtime,Using a bedtime pass which allows children to make a predetermined number of requests for parental attention while in bed,Giving sleep items,Delaying the bedtime,Sleep hygiene by providing suitable environment for child to sleep, providing proper bedtime routine , sleep wake schedules,Providing rewards as positive reinforcement.Pharmacological intervention to treat them accordingly as per standard protocol available,The components of the module will be decided based on Delphi method. Experts opinion will be taken and comprehensive module will be developed accordingly.
To validate the above module in children of ASD with sleep disorders by comparing sleep efficiency
时间窗: From baseline to 6 months
Change in sleep efficiency (%) as measured by PSG and actigraphy pre and post intervention.
次要结局
- To evaluate the agreement of actigraphy with polysomnography in determining sleep onset latency duration for evaluation of sleep disorders in children with autism spectrum disorder(6 months)
- Change in autism severity using CBCL (child behavior checklist) behavioral scales.(6 months)
- Change in autism severity using CARS-2(childhood autism rating scale -2).(6 months)
- Change in autism severity using ATEC (Autism treatment evaluation checklist) score(6 months)
- Change in autism severity using Development Profile 3 (DP3)(6 months)
- Change in autism severity using sensory profile.(6 months)
- Change in autism severity using Autism Behaviour Checklist (ABC) score(6 months)
- To evaluate the agreement of actigraphy with polysomnography in sleep efficiency for evaluation of sleep disorders in children with autism spectrum disorder(6 months)
研究者
Sheffali Gulati
Professor
All India Institute of Medical Sciences, New Delhi