Development, Implementation, and Evaluation of an Internet-based Behavioural Sleep Intervention for Children With NDD and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 2
- 主要终点
- Disorder of Initiating and Maintaining Sleep (DIMS) Score
研究概览
简要总结
More than 90% of children with neurodevelopmental disorders (NDD) experience sleep problems, whereas less than 25% of typically developing children experience sleep problems. Poor sleep can have significant consequences for children's physical and psychosocial health, as well their caregivers' well-being. The impact of sleep problems on daytime functioning is even greater in children with NDD. Although there are a range of factors that may disturb sleep in children with NDD, the most frequent cause of sleep disturbance is behavioural insomnia. There is some evidence that behavioural interventions can be effective in improving sleep in children with NDD. However, this has not been tested through well-designed, large-scale randomized controlled trials (RCTs). Moreover, there are a number of significant barriers to access for insomnia treatment for children; most importantly, sleep interventions are often only provided by specialists, limiting access to treatment services. Instead, behavioural insomnia is often treated with advice about sleep hygiene and with the supplement melatonin, which is, at best, a short-term solution. The investigators, an interdisciplinary team of researchers, will develop and evaluate the effectiveness of an online sleep intervention that will be widely accessible and sustainable and will have the potential to dramatically improve the health of children with NDD and their families.
详细描述
The purpose of the study is to develop and evaluate a web-based intervention for insomnia among children with neurodevelopmental disabilities (NDD), including Autism Spectrum Disorder (ASD), Fetal Alcohol Spectrum Disorder (FASD), Cerebral Palsy (CP), and Attention-Deficit/Hyperactivity Disorder (ADHD). Using the internet to deliver an intervention program for insomnia in children will address access barriers and provide evidence-based treatment to large numbers of children with NDD.
This study will adapt the Better Nights, Better Days (BNBD) e-intervention that was developed for typically developing children ages 1-10 years. The adaptation of BNBD will be led by a team of experts in the fields of sleep in children with NDD, including ASD, FASD, CP, and ADHD. The adaption will focus on behaviours that pose challenges to implementation of the evidence-based sleep intervention strategies (e.g., anxiety, parental stress, sensory sensitivities, language impairments, attention difficulties, etc.), rather than disorder-specific symptoms. The finalized intervention is tailored for primary caregives of children between the ages of 4-12 years, with mild to moderate NDD impairment.
The effectiveness of this intervention in improving children's sleep and daytime functioning, as well as secondary effects on the well-being of caregivers, will be evaluated through a randomized controlled trial (RCT). A parallel-design RCT (one per diagnostic group) will be conducted to determine if the web-based sleep intervention for NDD improves children's sleep and is associated with improved psychosocial outcomes for children and their caregivers.
This study is comprised of a development phase and an RCT phase.
Phase 1: Adaptation of web-based intervention and usability testing. A 3-step process will be used to adapt the BNBD e-intervention for use by caregivers of children with NDD.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are the primary caregiver of a child aged 4 to 12 years
- •live in any province/territory in Canada
- •have regular access to a high-speed internet connection and an email account
- •fluent in English or French
- •have self-reported listening and reading comprehension level of grade 6 or higher
- •have a child with ASD, CP, FASD, or ADHD, with level of impairment ranging from mild to moderate, in addition to insomnia
排除标准
- •caregiver wishes to "bed-share" with child
- •child has a probable intrinsic sleep disorder (e.g., sleep apnea)
- •child has a significant medical disorder that interferes with sleep (e.g., nighttime asthma attacks, tube-feeding, severe developmental disability affecting sensory systems such as vision)
- •child has a mental health disorder that has required hospitalization or residential care
- •child is non-ambulatory
- •child experiences enuresis at least 3 times per week that requires parental intervention during the night
- •child has a functional impairment below the 2nd percentile as determined by a caregiver report measure, the Adaptive Behavior Assessment System, 2nd Edition (ABAS-II)
- •child is currently being treated with anti-epileptic and/or psychotropic medications (e.g., stimulant medication for ADHD) and the medication or dose is not stable and/or expected to change within 6 months
结局指标
主要结局
Disorder of Initiating and Maintaining Sleep (DIMS) Score
时间窗: 8 months
Disorder of Initiating and Maintaining Sleep (DIMS) score calculated based on parent-report questionnaire data. DIMS is a measure that captures the degree of severity of sleeping problems, and is calculated using a sum of select questions from the Tayside Children's Sleep Questionnaire (administered to parents of children ages 4-5 years old) or the Sleep Disturbance Scale for Children (administered to parents of children ages 6-12 years old).
次要结局
- Actigraphy(8 months)
- Pediatric Quality of Life (Peds-QL)(8 months)
- Single Item Fatigue Impact Scale (SIFIS) to assess Caregiver Fatigue(8 months)
- Depression Anxiety Stress Scale (DASS-21) to assess Caregiver Psychological Health(8 months)
- Sleep Diary(8 months)
- Child Behavior Checklist (CBCL) to assess Child Psychosocial Health(8 months)
- Parenting Scale (PS) to assess Parenting Practices(8 months)