None listed
Conditions
Brief summary
Sleep problems are reported by Australian parents in up to 30% of infants and up to 40% of children during the early school years. The most common sleep problems are behavioural in nature and include difficulties going to bed, difficulties sleeping alone and waking during the night. Persistent sleep problems in children have significant adverse consequences for both child and parent. Cross-sectional studies show that impaired child sleep is associated with poorer child emotional and behavioural functioning, increased injury and obesity, and poorer parental mental health and health-related quality of life. Fortunately, there are brief, parent-oriented behavioural interventions that are effective in addressing numerous sleep problems. The current study will build on the many years of sleep intervention research carried out by MCRI. MCRI has successfully trialled the sleep strategies via face-to-face consultations delivered by clinicians and by written parent education materials only, The latter were effective in reducing child sleep problems and the need for hospital sleep clinic appointments, Families who participated in one of the trials suggested that access to information through a mobile phone-based application (app) would improve the intervention. In light of this suggestion and an increasingly digitised and patient centric healthcare environment, implementing the behavioural sleep intervention via a mobile app is an appropriate next step. The current study aims to investigate whether a sleep intervention provided to primary caregivers by a phone application (App) leads to better child sleep, reduced need to stay on a sleep clinic waitlist, and improved psychosocial outcomes for caregivers and children when compared to treatment as usual.
Interventions
The primary objective is to examine the effectiveness of a targeted, digital based sleep intervention (mobile app and web-based online sleep guide) on reducing parent reported child sleep problems, five weeks post enrolment.
The intervention has been extensively researched with promising results. This study is now testing an digital version of the empirically informed intervention. The App targets common behavioural sleeping problems in children and employs strategies that are standard clinica
The primary objective is to examine the effectiveness of a targeted, digital based sleep intervention (mobile app and web-based online sleep guide) on reducing parent reported child sleep problems, five weeks post enrolment. The intervention has been extensively researched with promising results. This study is now testing an digital version of the empirically informed intervention. The App targets common behavioural sleeping problems in children and employs strategies that are standard clinical practice. There are two phases to the App intervention; the ‘sleep check’ and intervention and monitoring phase. The sleep check asks the caregivers a number of questions to determine the nature of their child’s sleep problems (e.g. trouble falling asleep, nightmares) and the child’s sleep behaviours (e.g. uses an iPad before bed, irregular sleep times). An algorithm built into the app, uses the caregiver’s response to the sleep check questions to determine specific information and strategies that can help to improve the child's sleep problem. These strategies are displayed for the caregiver to choose and implement. Thus, the intervention is tailored to the child’s specific problems. The App intervention phase is tailored specifically to: i. Each of the reported sleep problems (nightmares, trouble falling and staying asleep etc.) ii. The strategies which are needed to address reported behaviours (e.g. sleep hygiene for those using iPads before sleep, routine setting for those going to bed at different times each night etc.). The number of problems (i) addressed by the intervention will vary depending on caregiver reports during the screening phase of the App. The caregiver will nominate the most dominant problem, which will be addressed first. Caregivers will be taken step-by-step through the strategies (ii) which are identified as useful for the first problem and the child’s reported behaviours. Caregivers will record the child’s sleep behaviours as they progress through the App (such as how many hours did your child sleep last night?). Once the child's first sleep problem is absent for two nights in a row, the caregiver moves onto the next sleep problem (if applicable). This will repeat until all of the sleep problems (and associated behaviours) have been addressed. As the number of sleep and behaviour problems will vary, so to will the tailored intervention. For this reason, the intervention may last between 3 nights to 2 weeks to complete the applicable strategies. Before they finish the strategies for each sleep problem, the App explains the common occurrence of extinction bursts. Extinction burst refers to likely sudden and temporary return of problematic sleep behaviours when the reinforcement (the intervention) is removed. If problematic behaviours return, or new ones arise, caregivers are instructed to re-do their child's sleep-check, which will direct them to the matching sleep strategies. Therefore, caregivers are encouraged to continue using the App as the need arises with access to provided until the end of the study (expected to be September 2019). If a caregiver uses a particular strategy but the sleep problem is not improving (where improvement is usually indexed by the absence of the sleep problem two nights is a row) – the App will prompt them to try another strategy. If the caregiver wishes to return to this strategy later, they can choose to do so. Caregivers are also given the option to access a web-based online sleep guide that contains similar information as the App. Caregivers are able to download PDF's of the strategies.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant (caregiver is the participant) must meet the following criteria to be enrolled in this study: • Participant (caregiver) is aged 18 years or older and the primary caregiver of a child referred to the Royal Children's Hospital (RCH) Sleep Clinic or self-referred from the community to study based on the child having behavioural sleep problems • Participant is capable of understanding an informed consent document and giving consent • Be a caregiver of a child is aged from 24 months, up to and including 13 years* with one or more behavioural sleep problem(s) as assessed by the American Academy of Sleep Medicine diagnostic criteria: o sleep onset association disorder o limit setting disorder o delayed sleep phase o primary insomnia o anxiety-related insomnia o night terrors, nightmares o sleep walking/talking and rhythmic movement disorders; The participant (caregivers) must also rate their child's sleep problem as moderate/severe according to the item below; “Over the last 2 weeks, how much of problem has your child’s sleep been? Response options are none, mild, moderate, or severe.
Exclusion criteria
Participants (caregivers) meeting any of the following criteria will be excluded from the study: • Known history of caregiver intellectual disability or neurological disorder • Identified to have insufficient English to complete the intervention and study questionnaire • Their child if the child has a major illness or disability (such as cerebral palsy, cancer, etc.). • Parents who rate their child's sleep problem as no/mild problem • Children who have a diagnosis of attention deficit hyperactivity disorder (ADHD) or autism may be included in the study depending on severity and the impairment associated with their condition. Cases where the child is non-verbal or has a known IQ less than 70 (many children with ASD/autism will have had IQ testing for as part of service provision) will be excluded from the study. Unclear cases will be referred to Dr Harriet Hiscock (Paediatrician and study P.I.; see next point). An IQ below 70 indicates intellectual disability, which is likely to interfere in the effectiveness of the intervention. While the App is used by the parent, the intervention is unsuitable for children with developmental delays as the intervention is based on the parent communicating new boundaries and instructions to the child based on their chronological age. • Where researchers are unclear regarding patient eligibility, their case will be referred to Dr Harriet Hiscock (Paediatrician and study P.I.) for review, based on information provided by the caregiver about the child’s functioning and communication. • Participants who do not have access to a mobile phone or device that can run the App (both Apple and Android devices are compatible with the App). • Their child’s sleep condition child is suspected to have a non-behavioural sleep problem, such as obstructive sleep apnoea (OSA). The likelihood of the sleep problem being an OSA will be established during the two phases of screening (see screening procedures in 5.3.3). OSA will either be advised by the referring clinician (Screening A) or by the caregiver during the screening call (Screening B). During the parent screening call, three items of the Child’s Sleep Habits Questionnaire will be asked to identify the existence of potential OSA.
Outcome results
None listed