Effects of Parent-based Educational Programme for Sleep Problems in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Child: change of insomnia symptoms (night waking)
研究概览
简要总结
Sleep problems are very common in children with ASD, with a prevalence rate as high as 78%, and often pose significant challenges and stress to the families. Sleep problems in children with ASD are strongly associated with the exacerbation of daytime symptoms, and poor parental sleep quality and mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ASD (aged 3-6). Eligible participants will be randomised to either intervention (three consultation sessions and four follow-up phone calls) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).
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
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of ASD attending paediatric developmental clinic or clinical psychology service at the Duchess of Kent Child Assessment Centre (DKCAC)
- •Clinical diagnosis of ASD would be made by either a Pediatrician or a Clinical Psychologist, using at least one of the following diagnostic tools: Childhood Autism Rating Scale, Second Edition (CARS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R) and clinical interview based on diagnostic criteria of ASD depicted in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
排除标准
- •Parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder
研究组 & 干预措施
Waiting-list control
Children in the waiting-list control group will receive usual clinical care.
Intervention group
The intervention will involve three consultation sessions and four follow-up phone calls with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.
干预措施: Sleep hygiene practices and behavioural intervention (Behavioral)
结局指标
主要结局
Child: change of insomnia symptoms (night waking)
时间窗: Baseline, immediately after the treatment
Change of the child's night waking measured by the Children's Sleep Habits Questionnaire (CSHQ) night waking score (3 items; score range: 3-9)
Child: change of insomnia symptoms (bedtime resistance)
时间窗: Baseline, immediately after the treatment
Change of the child's bedtime resistance measured by the Children's Sleep Habits Questionnaire (CSHQ) bedtime resistance score (6 items; score range: 6-18)
Child: change of insomnia symptoms (sleep onset delay)
时间窗: Baseline, immediately after the treatment
Change of the child's sleep onset delay measured by the Children's Sleep Habits Questionnaire (CSHQ) sleep onset delay score (1 item; score range: 1-3)
Child: Change of child's sleep
时间窗: Baseline, immediately after the treatment
Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ). The total score of CSHQ ranges from 33 to 99. A higher score reflects more sleep disturbance.
次要结局
- Child: Change of child's executive functions reported by parents(Baseline, immediately after the treatment)
- Parent: Change of parental stress(Baseline, immediately after the treatment)
- Parent: Change of parental self-reported sleep quality(Baseline, immediately after the treatment)
- Parent: Change of parental mood symptoms(Baseline, immediately after the treatment)
- Parent: Change of parental insomnia symptoms(Baseline, immediately after the treatment)
- Child: Change of child's behaviour & other clinical symptoms(Baseline, immediately after the treatment)
- Parent: Change of parental sense of competence and satisfactory in parenting(Baseline, immediately after the treatment)
- Parent: Parent's satisfaction to the treatment(Baseline, immediately after the treatment)
- Parent: Parent's overall health status(Baseline, immediately after the treatment)
研究者
Dr. Shirley Xin Li
Assistant Professor
The University of Hong Kong