Sleep Resource for Carers of Pre-school Aged Children; a Development and Pilot Study
Condition: Sleep Hygiene
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The literature highlights a need for the development and evaluation of evidence-based
      preventative resources that can be used at home as part of a child's bedtime routine. This
      study aims to provide a resource that pre-school children can play before bedtime with
      carers; in which they follow the characters on a journey through a fictional land, helping
      its inhabitants get a good night's sleep along the way. This will work by incorporating and
      encouraging positive sleep hygiene practices and relaxation exercises. It will include
      evidence-based practices shown to aid relaxation, using elements of mindfulness, deep
      breathing, imagery techniques and muscular relaxation. It will also include soothing
      activities and an appropriate level of child-caregiver interaction. The intervention is novel
      in that it aims to support children's sleep practices within the home environment, and
      therefore will have strong ecological validity. This research project therefore aims to
      develop and evaluate the sleep resource on a range of outcomes for both children and carer
      when played regularly together before bedtime.
    

Intervention name(s): Sleep Resource
Intervention type(s): Behavioral
Intervention description(s): The sleep resource is a card game to be played by children and caregivers as part of their bedtime routine. It includes exercises to help prepare the child for sleep, including deep breathing, mindfulness and light movement. Caregivers will be asked to use the resource for a minimum of three nights a week over a four week period, and complete pre and post outcome measures as well as sleep and resource use diaries for their children
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participant randomly assigned to either an intervention arm or control arm. Intervention arm will receive the sleep resource and be asked to use it over a 4 week period where as the control group will not.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep intervention; Pre-school children; Caregivers