Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Child: Change of child's sleep
研究概览
简要总结
Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6-12 years old;
- •With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- •With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).
排除标准
- •Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ<70);
- •Children with a neurological and/or medical condition that may lead to disordered sleep;
- •Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
- •Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.
研究组 & 干预措施
Intervention group
The intervention will involve two face-to-face consultation sessions and one follow-up phone call 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)
Waiting-list control
Children in the waiting-list control group will receive usual clinical care.
结局指标
主要结局
Child: Change of child's sleep
时间窗: Baseline, 1-week and 3-month posttreatment
Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)
次要结局
- Change of parental self-reported sleep quality(Baseline, 1-week and 3-month posttreatment)
- Child: Change of ADHD symptoms(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (sustained attention)(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (planning skills)(Baseline, 1-week and 3-month posttreatment)
- Change of parental sleep hygiene practice(Baseline, 1-week and 3-month posttreatment)
- Change of parental insomnia symptoms(Baseline, 1-week and 3-month posttreatment)
- Change of parental stress(Baseline, 1-week and 3-month posttreatment)
- Child: Change of daytime sleepiness(Baseline, 1-week and 3-month posttreatment)
- Child: Change of other sleep measures(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (cognitive flexibility)(Baseline, 1-week and 3-month posttreatment)
- Change of parental sleep parameters as measured by actigraphy(Baseline, 1-week and 3-month posttreatment)
- Change of parental mood symptoms(Baseline, 1-week and 3-month posttreatment)
- Child: Change of child's behaviour & other clinical symptoms(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (working memory)(Baseline, 1-week and 3-month posttreatment)
- Change of parental daytime sleepiness(Baseline, 1-week and 3-month posttreatment)
- Change of parental daytime fatigue(Baseline, 1-week and 3-month posttreatment)
- Parent's satisfaction to the treatment(Baseline, 1-week and 3-month posttreatment)
- Child: Change of quality of life(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (auditory attention span)(Baseline, 1-week and 3-month posttreatment)
- Child: Change of cognitive performance (cognitive processing)(Baseline, 1-week and 3-month posttreatment)
研究者
Dr. Shirley Xin Li
Assistant Professor
The University of Hong Kong