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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Control Trial (RCT) testing the use of an App intervention to improve behavioural sleep problems in children and reduce the need for specialist clinical services.
Scientific title
A Randomised Control Trial (RCT) testing the use of an App intervention to improve behavioural sleep problems in children and reduce the need for specialist clinical services.
Secondary ID [1] 295565 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parent reported behavioural sleep problem 308837 0
Sleep limit setting disorder 309394 0
Delayed sleep phase 309395 0
Primary insomnia 309396 0
Anxiety-related insomnia 309397 0
Night terrors/nightmares 309398 0
Sleep walking/talking 309399 0
Rhythmic movement disorders 309400 0
Sleep onset association disorder 309411 0
Condition category
Condition code
Mental Health 307766 307766 0 0
Other mental health disorders

Study type
Description of intervention(s) / exposure
The primary objective is to compare the effectiveness of a targeted, app-based sleep intervention in reducing parent-reported child sleep problems, five weeks post-randomisation, compared with a control group who remain on the hospital Sleep Clinic waitlist and are not offered the app.
The intervention has been extensively researched with promising results. This study is now testing an App version of the empirically informed intervention. The App targets common behavioural sleeping problems in children and employs strategies that are standard clinical practice. Participants will have access to the app for five weeks. Researchers will monitor to ensure the app has been downloaded by the parent, and remind/support them to download the app where required. Researchers will not remind or encourage users to keep using the app, as outcomes also include app engagement (without researchers prompting use). Use analytics will be collected to observe app engagement.

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.

Regardless of the group to which they are randomly assigned, caregivers will remain on the waiting list to attend the Royal Children's Hospital Sleep Clinic for assistance with their child’s sleep as part of standard care. Caregivers may decide they no longer need the appointment and can cancel at their own discretion.
Intervention code [1] 301863 0
Treatment: Other
Comparator / control treatment
Caregivers allocated to the control arm receive standard treatment through their referring clinician and remain on the waiting list to attend the Royal Children's Hospital Sleep Clinic for assistance with their child’s sleep. Parents typically wait up to four months for an appointment at the RCH Sleep Clinic, however this varies depending on the current volume of referrals to the clinic.
Standard treatment refers to the any treatment or resources provided by their referring clinician (e.g. the general practitioner or maternal child health nurse who referred the participant and their child to the RCH sleep clinic).
Control group

Primary outcome [1] 306757 0
The primary outcome is change in parent report of child sleep problems. This will measured by caregiver report using the single item “Over the last 2 weeks, how much of a problem has your child’s sleep been?” Response options: none, mild, moderate or severe. Responses will be dichotomised into sleep problem “no” none/mild versus “yes” moderate/severe.
Timepoint [1] 306757 0
Measured at baseline and 5 weeks post randomisation.
Secondary outcome [1] 349500 0
Change in caregiver's desire to stay Sleep Clinic waitlist.
This will be based on caregiver’s yes/no response to the item ‘Do you feel your child needs to be seen at the Royal Children’s Hospital Sleep Clinic?’ at the 5-week post randomisation survey.
Timepoint [1] 349500 0
At 5 weeks post randomisation.
Secondary outcome [2] 349547 0
Change in the severity of the child's sleep problems according to the following validated measure:
Total scores on either the Brief Infant Sleep Questionnaire (BISQ; 6-35 months) or Children’s Sleep Habits Questionnaire (CSHQ; 3-12 years).
Timepoint [2] 349547 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [3] 349548 0
Change in caregiver perception of the child's temperament according to the following validated item:
Single item “Compared to other children, do you think your child is...” Response options: much easier than average, easier than average, average, more difficult than average, much more difficult than average, cannot say.
Timepoint [3] 349548 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [4] 349549 0
Changes in caregiver mental health according to the following validated measure:
Total score on the Kessler-6
Timepoint [4] 349549 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [5] 349550 0
Changes in caregiver sleep quantity measured according using the following items adapted from the Pittsburgh Sleep Quality Questionnaire:

Single item regarding quantity: “How would you rate your own sleep quantity?” Response options: not nearly enough, not quite enough, enough, more than enough.
Timepoint [5] 349550 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [6] 349551 0
Cost-effectiveness of intervention
The cost-effectiveness of the intervention will be assessed from the perspective of the healthcare system including Medicare items billed for sleep clinic consultations completed. Data will be extracted from the child's hospital electronic medical record.
Timepoint [6] 349551 0
4 months post-randomisation
Secondary outcome [7] 349552 0
App acceptability
User app acceptability will be assessed in the intervention group only and will include both quantitative and qualitative data responses via questionnaire. Qualitative and quantitative responses will be assessed as one composite secondary outcome.

Quantitative items: Parents will be asked in surveys to rate how much they agree with seven study specific items. These relate to the ease of use (e.g. the app was easy to use), information contained within the app (e.g. there was too much information in the app) and general satisfaction (e.g. I would like to use the app in future). Items will be rated in a scale from 1 (totally disagree) to 5 (totally agree). One final item, Please rate your OVERALL SATISFACTION with Sleep Well app, is rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). Parents are also asked "Whilst using the app, did you contact your local health practitioner (e.g. GP, maternal child health nurse) to get more information about to how manage your child’s sleep problems? "

Qualitative: Parents will be asked a number of quantitative items relating to their child's need for an outpatient sleep clinic appointment. They are asked to explain why they still require an appointment, or why they no longer need an appointment for their child's sleep problem. They are then asked to describe the best and worst things about the app, what would improve the app, and why they would not recommend the app to other parents (for those who would not recommend the app).
Timepoint [7] 349552 0
5 weeks post randomisation.
Secondary outcome [8] 349553 0
Health economics
Costs from the family perspective will be compared between the two groups. Parents will be asked to report health service use and costs for the child's sleep problem, caregiver time off from usual activities due to their child’s sleep problems, and medications used to manage the child's sleep problem.
Timepoint [8] 349553 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [9] 350560 0
Changes in child behaviour according to the single item question; “compared to other children, do you think your child is:”
Response options: much easier than average, easier than average, average, more difficult than average, much more difficult than average, cannot say.
Timepoint [9] 350560 0
Baseline and at 5 weeks post randomisation.
Secondary outcome [10] 351111 0
Changes in caregiver sleep quality measured according using the following item adapted from the Pittsburgh Sleep Quality Questionnaire:
Single item regarding quality: “How would you rate your own sleep quality?” Response options: very bad, fairly bad, fairly good, very good
Timepoint [10] 351111 0
Baseline and at 5 weeks post randomisation.

Key inclusion criteria
Participant (caregiver is the participant) must meet the following criteria to be enrolled in this study:
• Participant is aged 18 years or older and the primary caregiver of a child referred to the Royal Children's Hospital (RCH) Sleep Clinic
• Participant is capable of understanding an informed consent document and giving consent
• Be a caregiver of a child is aged from 6 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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed. Eligibility is determined prior to randomization. Randomisation will occur once the caregiver is deemed eligible, has completed consent and has completed the baseline questionnaire.

Randomisation will be managed via the REDCap application. An independent statistician will input a computer-generated randomisation sequence that will randomly assign the families. Researchers and participants will not be blind to the study once participants have been allocated to either the intervention or control arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation. Stratification by age will be used (0-5 years vs. > 5 years).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Intention-to treat comparisons of the trial arms will be conducted. Means and standard deviations will be used to describe normally distributed data, medians and interquartile ranges to describe skewed data and numbers and percentages will describe categorical data. For bivariate analyses, t-tests will be used and Fisher’s exact for categorical data.

Linear regression models will be fitted to estimate mean differences between trial arms for continuous outcomes (e.g. K-6) and logistic regression to measure odds ratio to compare binary outcomes (e.g. caregiver report of moderate/severe child sleep problems – yes/no) between trial arms. Models will account for baseline score for each outcome, where applicable.

If there are a number of participants who attend an appointment at the Royal Children's Hospital Sleep Clinic during the life of the study, then we will also conduct a per protocol analysis.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 11447 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 23463 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 300141 0
Name [1] 300141 0
The Royal Children's Hospital Foundation
Address [1] 300141 0
Level 2/48 Flemington Rd, Parkville VIC 3052, Australia
Country [1] 300141 0
Primary sponsor type
Murdoch Children's Research Institute
50 Flemington Road, Parkville, VIC 3052, Australia
Secondary sponsor category [1] 299543 0
Name [1] 299543 0
Address [1] 299543 0
Country [1] 299543 0

Ethics approval
Ethics application status
Ethics committee name [1] 300987 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 300987 0
Research Ethics & Governance
The Royal Children's Hospital
Level 4, South Building
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 300987 0
Date submitted for ethics approval [1] 300987 0
Approval date [1] 300987 0
Ethics approval number [1] 300987 0

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3014 3014 0 0

Principal investigator
Name 85478 0
Prof Harriet Hiscock
Address 85478 0
Murdoch Children's Research Institute
50 Flemington Road, Parkville, Victoria, 3052
Country 85478 0
Phone 85478 0
+61 3 9345 6910
Fax 85478 0
Email 85478 0
Contact person for public queries
Name 85479 0
Prof Harriet Hiscock
Address 85479 0
Murdoch Children's Research Institute
50 Flemington Road, Parkville, Victoria, 3052
Country 85479 0
Phone 85479 0
+61 3 9345 6910
Fax 85479 0
Email 85479 0
Contact person for scientific queries
Name 85480 0
Prof Harriet Hiscock
Address 85480 0
Murdoch Children's Research Institute
50 Flemington Road, Parkville, Victoria, 3052
Country 85480 0
Phone 85480 0
+61 3 9345 6910
Fax 85480 0
Email 85480 0

No data has been provided for results reporting
Summary results
Not applicable