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临床试验/NCT05097703
NCT05097703已完成不适用

The Development and Pilot of a Sleep Resource for Carers of Pre-school Aged Children to be Used as Part of the Bedtime Routine

University of Surrey2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Change in Resource use diaries

研究概览

简要总结

Evidence suggests sleep difficulties in pre-school children (aged 3-6 years) are highly prevalent and that carer knowledge of good sleep hygiene practices and the importance of them is relatively poor. Establishing a regular bedtime routine, involving activities shown to induce relaxation and prepare the child for sleep, is important in promoting optimal sleep duration and quality. However, there appears to be a lack of evidence-based resources that are empirically evaluated for carers to use with children within the family home. This study proposes to co-develop and pilot a new sleep resource. This will be an interactive storybook which guides children and their carers through a number of activities, designed to increase relaxation and prepare the child for sleep. A randomised control trial (RCT) design will be used, with an intervention group and a waitlist control group who will receive the resource at the end of the intervention period. Both groups will be asked to complete pre-intervention, post-intervention and follow-up measures; as well as keep sleep diaries for their children for the duration of the intervention period. The intervention group will also be asked to keep a diary of resource use and then to complete a feedback survey post-intervention. They will be asked to use the resource for a minimum of three days a week for a one-month period. This pilot aims to assess the acceptability of the resource and provide initial findings in terms of its efficacy on a range of sleep related outcomes.

详细描述

Typically, 3-6-year olds are estimated to require around 10-12 hours of sleep per day (The Sleep Council, 2019). This is thought to be essential for healthy growth and wellbeing, and is significantly associated with predictors of adult health (Bathory & Tomopoulos, 2017). Sleep disturbances and difficulties are found to be highly prevalent amongst infants and young children (Honaker & Meltzer, 2014). The literature estimates between 25% to 50% of pre-school aged children get too little sleep (Owens & Mindell, 2011), and a quarter of parents report sleep difficulties in their child's first five years of life (Bathory & Tomopoulos, 2017). This is a concern as evidence suggests early childhood to be a critical time for establishing sleep habits which have implications for sleep quality throughout the lifespan (Bonuck, Blank, True-Felt & Chervin, 2016). Research also shows a well-established link between sleep and long-term health outcomes for children. A recent review shows poor sleep to negatively effect physical health factors such as weight problems, as well as cognitive development, cognitive performance and behavioural functioning (Spruyt, 2019). Thinking more broadly about the impact on families, sleep problems in children have been found to impact the quality of maternal sleep, which then acts as a significant predictor of maternal mood, stress and fatigue (Meltzer & Mindell, 2007). Mindell and Williamson (2018) highlight that investing in not only interventions for disordered sleep but preventative strategies to promote healthy sleep is therefore essential in promoting positive health outcomes for children and their family systems.

Implementing sleep hygiene practices with children has been found to be positively associated with better sleep across a range of ages (Mindell, Meltzer, Carskadon & Chervin, 2009). Sleep hygiene can be defined as a set of specific behaviours and activities that are conducive to increasing healthy and adequate sleep (Perlis, Smith & Pigeon, 2005). This includes the consideration of factors such as environmental noise, bedroom environment, light exposure, exercise, temperature and electronic device use (Richdale & Schreck, 2019). Mindell and Williamson (2018) also suggest appropriate communication and contact with carer as an important aspect of sleep hygiene. The literature suggests that such techniques should be encompassed within a regular and structured bedtime routine to be most effective. Following a bedtime routine is associated with positive sleep outcomes; such as earlier bedtimes, increased sleep duration, reduced night time awakenings and reported caregiver sleep quality (Mindell and Williamson, 2018). Such outcomes have been observed in as little as two weeks from implementing sleep hygiene practices (Mindell, Leichman, Lee, Williamson & Walters, 2017). Encouraging bedtime routines that include sleep hygiene practices could therefore be a cost-effective way to promote positive childhood sleep outcomes, which could then have beneficial effects on a broad range of child development factors. Despite this, research suggests that caregiver knowledge in regards to their children's sleep habits is poor (McDowall, Galland, Campbell & Elder, 2017). Studies have shown increased knowledge of sleep hygiene to be associated with an increased number of positive sleep practices and increased sleep duration in young children (Owens & Jones, 2011). It has therefore been suggested that caregiver education on sleep hygiene could be used as a first line intervention for sleep problems in young children (McDowall, Galland, Campbell & Elder, 2017). This indicates that preventative interventions and resources for childhood sleep problems would likely benefit by including a degree of caregiver education.

Evidence-based interventions to promote healthy sleep habits in young children have largely focused on sub-groups of children and so may not be transferable to the general population (Busch, Altenburg, Harmsen and Chinapaw, 2017). For example, sleep interventions have been developed for children with autistic spectrum condition (Johnson et al., 2013; Turner & Johnson, 2013), intellectual disabilities (Stuttard, Beresford, Clarke, Beecham & Curtis, 2015), children with lymphoblastic leukaemia (Zupanec, Jones, McRae, Papaconstantinou, Weston & Stremler, 2017), those with specific sleep difficulties (Schlarb & Brandhorst, 2012; Kuhle, Urschitz, Eitner & Poets, 2009), as well as children living in socioeconomic adversity (Caldwell, Ordway, Sadler & Redeker, 2020; Ordway et al., 2020). In terms of interventions for the general population to promote healthy sleep, Busch, Altenburg, Harmsen and Chinapaw (2017) provide a review of those developed for children aged 4-12 years. They conclude that due to few high-quality studies, the effectiveness of any specific intervention strategy is inconclusive. They recommend the need for further evaluation of systematically developed interventions to encourage positive sleep habits in children. This current study's investigators argue the need for further research evidence examining which methods are effective in promoting healthy sleep in pre-school aged children, to then aid the development of widely accessible evidence-based resources.

Resources (e.g. storybooks, games) designed to be used with young children before bed are widely available. However, the efficacy of these in terms of promoting positive sleep outcomes relies mainly on anecdotal evidence from carer in the form of online reviews and blogs. Resources that have been evaluated in research for this age group tend to be in the form of educational interventions rather than ones that can be used at home. For example, the 'Sweet Dreamzzz Early Childhood Sleep Education program (Wilson, Miller, Bonuck, Lumeng & Chevrin, 2014) was developed for pre-school children and parents. This included a one-off workshop for parents and a two-week classroom curriculum for children to help establish bedtime routines involving positive sleep hygiene activities. Results included an increase of 30 minutes per night for children's sleep at one-month follow-up and increased parental knowledge of sleep hygiene practices; though this effect was not lasting. Schlarb and Branhorst (2012) developed an internet-based intervention, 'Mini-KiSS Online', for sleep disturbances in children aged 6-months to 4-years and their parents. Parents attended six online intervention sessions which included psychoeducation on sleep and implementing strategies to promote sleep hygiene including; imaginational exercises, bedtime stories, improving sleep environment; cognitive-behavioural techniques and relaxation exercises. Results indicate the intervention was highly accepted by parents and included improvements in falling asleep, less night time awakenings and less bedtime resistance. Though effect sizes were small to medium and results were limited by a high dropout rate (46%). Educational treatment programs rely on carer to independently implement learnt techniques which may be a reason for high dropout rates, as well as a high variation in how the strategies are implemented. This suggests that carer may benefit from resources they can use within the home, to help scaffold the bedtime routine and promote sleep hygiene activities in 'real time' with their children.

In terms of an evaluated resource that can be used at home, one study evaluated the game 'Perfect Bedroom: learn to sleep well'. This is a digital interactive game for 7-9-year olds, which encourages children to map out their bedtime routine to include sleep promoting activities and limit negative sleep hygiene activities such as the use of electronic devices. Preliminary results indicated the potential for this tool to be effective in promoting healthy sleep habits (Almondes & Leonardo, 2019), though the sample size was small (n=13). The authors also described this as the first study that used a 'serious game' (game designed for a primary purpose other than entertainment) to promote healthy sleep habits in children. In terms of study's evaluating serious games that promote healthy sleep habits for a younger age group in the home environment, this current project would therefore be the first to our knowledge to do so.

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

入选标准

  • Carer-child dyads (3-6 years old) who feel their child could benefit from a resource designed to improve sleep outcomes.
  • Fluent in English.
  • Carers must hold legal parental responsibility for the child taking part in the study with them and be able to provide consent on their behalf.

排除标准

  • Children who have a diagnosis of neurological disorder, cardiovascular or genetic diseases.
  • Carers and or child unable to understand English.
  • Carers who are not regularly available to assist children with the bedtime routine (e.g. do not live in the family home).

结局指标

主要结局

Change in Resource use diaries

时间窗: 4 week period from baseline

Carer to fill out for child every day for four week period. To include time started using resource, length of time playing and the setting played in (e.g. bedroom, lounge).

Change in Carer reported child sleep diaries

时间窗: 4 week period from baseline

Carer to fill out sleep diary for child every day for four week period. To include time put to bed, time taken to fall asleep, frequency and duration of night time awakenings and time woke in morning.

Outcome of Feedback survey

时间窗: 1 month

Intervention group carers to complete feedback survey on the acceptability and utility of the resource. To include quantitative and qualitative feedback.

次要结局

  • Change in Children's Sleep-Wake Scale (CSWS) (LeBourgeois & Harsh, 2016)(Baseline, 1 month and 2 month post follow ups)
  • Change in General Sleep Information (GSI) (Akacem, Wright & LeBourgeois, 2016)(Baseline, 1 month and 2 month post follow ups)
  • Change in Strengths and Difficulties Questionnaire, parent version (SDQ) (Goodman, 1997)(Baseline, 1 month and 2 month post follow ups)
  • Change in Parenting Stress Scale (PSS) (Berry & Jones, 1995)(Baseline, 1 month and 2 month post follow ups)
  • Change in Parent-Child Sleep Interactions Scale (PCSIS) (Alfano, Smith, Reynolds, Reddy & Dougherty, 2013)(Baseline, 1 month and 2 month post follow ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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