ACTRN12620001276943已完成未知
Telehealth Sleeping Sound ASD: A pilot feasibility and acceptability randomized control trial of a brief behavioural sleep intervention program for autistic children aged 5-12 years.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 61
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 5 Years 至 o limit(—)
- 性别
- All
入选标准
- •Eligibility requirements for child:
- •Multidisciplinary diagnosis of DSM-IV Autistic Disorder, Asperger’s Disorder or DSM-5 ASD, as indicated by paediatrician or a confirmed diagnosis as cited in a clinical report AND
- •Aged 5-12 years AND
- •A score above the clinical cut off (11 or more) on the Social Communication Questionnaire Lifetime form (10 minutes completion time) AND
- •Having a moderate or severe sleep problem by parent report and need to meet criteria for at least one of the following behavioural sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria: chronic insomnia (due to problems of sleep onset association, limit setting, prolonged night time waking, primary insomnia, early waking, or anxiety) or delayed sleep phase disorder AND
- •Child has not been diagnosed with an intellectual disability on parent report
- •Living in Australia
- •Participants currently taking melatonin as well as any other medications (SSRI’s etc.) will be included in the trial, if they continue to meet the above eligibility criteria. Information regarding medication will be collected as part of the parent survey.
- •Parent/caregiver eligibility requirements:
- •Parent/caregiver of child who meets child eligibility requirements AND
- •Living in Victoria, Australia AND
- •Have sufficient English proficiency to provide informed consent and answer online questionnaires
排除标准
- •Participants will be excluded if they have any comorbid medical (e.g., tuberous sclerosis, nocturnal seizures, blindness), neuropsychiatric (e.g., Tourette’s) or genetic (e.g., Fragile X disorder) conditions associated with intellectual disability or disturbing regular sleep patterns.
- •Children with suspected obstructive sleep apnoea (OSA) will be identified using 3 OSA items from the Child Sleep Habits Questionnaire. If a parent endorses snoring usually or sometimes and one of the other two items of the OSA screening questions as usually or sometimes), that child will be referred to a paediatric fellow for a follow up assessment sleep apnoea. If the child is determined to have sleep apnoea from this assessment, they will be excluded from the research study and referred to their paediatrician for treatment.
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