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Trial registered on ANZCTR


Registration number
ACTRN12618001446257
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
28/08/2018
Date last updated
30/08/2019
Date data sharing statement initially provided
16/04/2019
Date results provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the use of an app intervention to improve behavioural sleep problems in children.
Scientific title
Testing the use of an app intervention to improve behavioural sleep problems in children.
Secondary ID [1] 295565 0
Nil Known
Universal Trial Number (UTN)
U1111-1217-5004
Trial acronym
Nil
Linked study record
Nil

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 314213 0
Treatment: Other
Comparator / control treatment
The study design is no longer an RCT, with a control and intervention arm. The content relating to comparator/control treatment is no longer relevant.
Control group
Uncontrolled

Outcomes
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 enrolment.

.
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 enrolment.
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 5 weeks post enrolment.
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 5 weeks post enrolment.
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 5 weeks post enrolment.
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 5 weeks post enrolment.
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
User acceptability of the digital intervention will be assessed using both quantitative and qualitative data responses via questionnaire. 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/online sleep guide was easy to use), information contained within the app/online sleep guide (e.g. there was too much information in the app) and general satisfaction (e.g. I would like to use the app/online sleep guide 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 Be Well app/online sleep guide, is rated on a scale from 1 (very unsatisfied) to 5 (very satisfied). Parents are also asked "Whilst using the app/online sleep guide, 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 experience using the app/online sleep guide. They are then asked to describe the best and worst things about the app/online sleep guide, what would improve the app/online sleep guide, and why they would not recommend the app/online sleep guide to other parents (for those who would not recommend the app/online sleep guide). Parents recruited through the Royal Children's Hospital Sleep Clinic will additionally be asked about 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.


Timepoint [7] 349552 0
5 weeks post enrolment.
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 5 weeks post enrolment.
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 5 weeks post enrolment.
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 5 weeks post enrolment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As the study is no longer an RCT, allocation concealment is no longer relevant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As the study is no longer an RCT, sequence generation is no longer relevant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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 baseline and 5-weeks post enrolment 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).

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
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/09/2018
Actual
10/10/2018
Date of last participant enrolment
Anticipated
31/07/2019
Actual
2/08/2019
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
156
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
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
Charities/Societies/Foundations
Name [1] 300141 0
The Royal Children's Hospital Foundation
Country [1] 300141 0
Australia
Primary sponsor type
Other
Name
Murdoch Children's Research Institute
Address
50 Flemington Road, Parkville, VIC 3052, Australia
Country
Australia
Secondary sponsor category [1] 299543 0
None
Name [1] 299543 0
Address [1] 299543 0
Country [1] 299543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300987 0
The Royal Children’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 300987 0
Ethics committee country [1] 300987 0
Australia
Date submitted for ethics approval [1] 300987 0
07/03/2018
Approval date [1] 300987 0
19/04/2018
Ethics approval number [1] 300987 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3014 3014 0 0
/AnzctrAttachments/375605-38060 Ethics and Governance 20.04.18.pdf (Ethics approval)

Contacts
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
Australia
Phone 85478 0
+61 3 9345 6910
Fax 85478 0
Email 85478 0
harriet.hiscock@rch.org.au
Contact person for public queries
Name 85479 0
Harriet Hiscock
Address 85479 0
Murdoch Children's Research Institute
50 Flemington Road, Parkville, Victoria, 3052
Country 85479 0
Australia
Phone 85479 0
+61 3 9345 6910
Fax 85479 0
Email 85479 0
harriet.hiscock@rch.org.au
Contact person for scientific queries
Name 85480 0
Harriet Hiscock
Address 85480 0
Murdoch Children's Research Institute
50 Flemington Road, Parkville, Victoria, 3052
Country 85480 0
Australia
Phone 85480 0
+61 3 9345 6910
Fax 85480 0
Email 85480 0
harriet.hiscock@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will not be shared


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo At follow up, caregivers reported fewer moderate/s... [More Details]
Study results articleYes Journal of Paediatrics and Child Health (In Press ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSleep Well Be Well: Pilot of a digital intervention to improve child behavioural sleep problems.2021https://dx.doi.org/10.1111/jpc.15106
N.B. These documents automatically identified may not have been verified by the study sponsor.