Better Nights, Better Days: Improving Psychosocial Health Outcomes in Children With Behavioural Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 534
- 试验地点
- 2
- 主要终点
- Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Actigraphy
研究概览
简要总结
Up to 25% of children suffer from sleep problems categorized as "insomnia": difficulty settling, falling asleep, and staying asleep. This leads to daytime sleepiness and negatively effects behaviour, mood, and academic performance. It also has negative effects on primary caregiver's sleep and their daytime functioning. Despite robust evidence supporting the efficacy of behavioural treatments for insomnia in children, very few receive these treatments. The most common treatment for insomnia in children is medication. This pattern of care is troubling because there are no approved medications for insomnia in children, and there are concerns about the safety and side effects of these medications. One of the primary reasons for the low rate of evidence-based treatment is the shortage of available treatment resources for both parents and health care providers.
When evidence-based treatments are available, they are usually provided in a traditional service delivery framework. These traditional approaches are often very difficult for parents to access due to scheduling conflicts, incidental costs, and travel difficulties. Thus, there is a critical need for access to effective interventions focused on insomnia for children, and increased knowledge for parents and health care providers about appropriate treatments for insomnia.
The Better Nights, Better Days (BNBD) program will provide a potential solution to one of the most common treatment barriers: access to care. BNBD will provide a readily accessible distance treatment via the internet, to increase access to evidence-based care for insomnia in typically developing children aged 1 to 10. BNBD was developed based on evidence-based programs and extant literature. The investigators will conduct a randomized controlled trial (RCT) in which participants (primary caregivers of children ages 1 to 10 years with insomnia) will be assigned to Intervention or Usual Care based on a 1-to-1 allocation. The effects of this behavioural sleep intervention will be assessed at 4 and 8 months post baseline assessment. Assessment will include both sleep and daytime functioning of the children, and daytime functioning of their caregivers.
This study aligns with the recognized need to more rapidly transfer new scientific knowledge to improve patient care and population health, and targets the validation of new treatment delivery models to increase availability of effective treatment.
详细描述
Rationale:
Evidence demonstrates that behavioural interventions should be the first line of treatment for children with insomnia, but this is not typically the case. Evidence-based behavioural intervention protocols are not readily available for clinical use, and their lack of implementation indicates inadequate knowledge translation. When evidence-based treatments are available, they are usually provided in a traditional service delivery framework (i.e., face-to-face therapy, small group therapy). These traditional approaches are often very difficult for parents to access due to scheduling conflicts, incidental costs, and travel difficulties. Thus, there is a critical need for access to effective interventions focused on insomnia for children, and increased knowledge for parents and health care providers about appropriate treatments for insomnia. The Better Nights, Better Days (BNBD) program will bridge this gap as we will provide a potential solution to one of the most common treatment barriers, access to care.
Intervention:
The BNBD intervention for children aged 1 to 10 years with insomnia is a bilingual, self-guided program delivered online. The intervention incorporates evidence-based strategies, including sleep education, positive routines, faded bedtime with response cost, sleep restriction, extinction/graduated extinction, stimulus fading, and scheduled awakenings. The intervention is comprised of five sessions made available sequentially to participants. The completion time of the intervention will range from 5-10 weeks. Each session will provide factual information to parents, strategies for implementation of best practices to address sleep problems, and access to additional help and advice. There is also a "Reward Centre" where parents can learn how to use reinforcement for children (e.g., sticker charts) to help support the implementation of these sleep intervention strategies. Participants complete a short Sleep Diary for a minimum of 5 days for each session throughout this intervention so that they can receive feedback on their progress. The intervention delivers the interactive, personalized cognitive and behavioural change strategies accessed through participants' desktops, laptops, tablets and smartphones. The program can be used at a time that is convenient for the participants, removing barriers to care and providing services in the comfort and privacy of their own homes.
Objectives and Hypotheses:
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
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential participants must meet the following criteria to be eligible to participate in the study:
- •Primary caregiver of a child aged 1 to 10 years.
- •Live in any province or territory in Canada.
- •Have regular access to high speed internet connection and an email account.
- •Comfortable communicating in English or French for day-to-day tasks (e.g., listening to the news on the radio or watching TV, reading books, magazines, etc.).
- •Child has insomnia, defined as having Sleep Onset Disturbance. For Sleep Onset Disturbance, child must meet two of the following three criteria. These episodes must have been occurring for at least one month:
- •More than three reunions for 12-24 month olds/more than two reunions for >24 month olds that occur two or more nights per week
- •30 or more minutes to fall asleep for 12-24 month olds/20 or more minutes to fall asleep for >24 month olds
- •Parent remains in room for sleep onset for two or more nights per week
排除标准
- •Potential participants who meet any of the following criteria are not eligible to participate in the study:
- •Parent wishes to "bed-share" with his/her child.
- •Child has a probable intrinsic sleep disorder (e.g., sleep apnea) as assessed using the Pediatric Sleep Questionnaire (PSQ).
- •Child has a significant medical disorder that interferes with sleep (e.g., asthma attacks during night, tube feeding, non-ambulatory, severe developmental disability affecting sensory systems such as vision).
- •Child has a mental health disorder that has required hospitalization or residential care and/or current use of psychotropic medications which are known to interfere with sleep (e.g., stimulant medication for ADHD).
结局指标
主要结局
Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Actigraphy
时间窗: 8 months
Actigraphy involves measurement of motor activity using an accelerometer-based, battery-operated device. The investigators will use actigraphy to collect information about changes in children's sleep efficiency (captured from lights out to awakening), sleep onset, total sleep time, and night wakings from baseline to 4 month and 8 month follow-up. Actigraphy data have been shown to be highly concordant with polysomnographic (PSG) data for identifying sleep and waking (85-90%) and to distinguish effectively between sleep-disturbed children and controls. The investigators will use Philps Respironics Actiwatch 2 actigraphs. Actigraphy data will be collected for a one week period at baseline, and 4 months and 8 months post randomization. Participants are instructed to ensure their child wears their actigraph during the 7 days of Sleep Diary collection.
Change in Sleep Efficiency and Onset Latency from Baseline to 8 Month Follow-up with Sleep Diary
时间窗: 8 months
Sleep Diaries will be used to document sleep variables over a number of days/nights. A composite score will capture bedtime resistance, difficulties falling asleep and night wakings, as these are the key features of insomnia in children. Parents record information about their children's sleep and sleep behaviours for a one week. The Sleep Diary contains 25 items specifically measuring; sleep duration, night time sleep duration, daytime sleep duration, sleep onset latency, bedtime, wake time, presence and frequency of night awakening, and the presence and frequency of bedtime resistance. Sleep Diaries also provide a measure of time spent in bed extracted from the time the light was turned off ("Down for the night") to the time lights were turned on ("Up for the day"). Sleep Diaries are administered to participants at the 3 assessment periods to assess change over baseline to 4 month and 8 month follow-up. Sleep diaries have demonstrated good face validity and high internal consistency.
次要结局
- Tayside Children's Sleep Questionnaire (TCSQ)(8 months)
- Pediatric Quality of Life (Peds-QL)(8 months)
- Single Item Fatigue Impact Scale (SIFIS)(8 months)
- Parenting Scale (PS)(8 months)
- Depression Anxiety Stress Scale (DASS-21)(8 months)
- Child Behaviour Checklist (CBCL)(8 months)
- Teacher Report Form (TRF)(8 months)
- Sleep Disturbance Scale for Children (SDSC)(8 months)