Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000613404
Ethics application status
Approved
Date submitted
26/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of a digital sleep application by autistic adolescents with insomnia
Scientific title
Use of a digital sleep application by autistic adolescents with insomnia: A randomised pilot trial
Secondary ID [1] 314503 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomina 337565 0
Autism Spectrum Disorder 337566 0
Condition category
Condition code
Mental Health 333938 333938 0 0
Autistic spectrum disorders
Mental Health 333939 333939 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep Ninja is a digital cognitive behavioural therapy intervention developed through a co-design process with 12 to 16-year-olds. It is free and publicly available in Australia on iOS and Android devices. The application includes 6 modules covering core aspects of CBT-I including (a) sleep scheduling; (b) stimulus control strategies; (c) sleep hygiene for evenings and daytime; (d) cognitive therapy including how to deal with thoughts that can prevent sleep onset (e.g., repetitive worrying) (e) identification and planning for high-risk situations and diversions from sleep routine; and f) relapse prevention. It also includes a sleep tracking function, sleep scheduling based on required wake time and age-dependent sleep duration recommendations, personalised wind-down routines and reminders, a series of sleep tips, and general information about sleep. The basis of the app is that users progress through 6 modules or “belts”, starting at a “white belt” and working their way up to “black belt” status. To progress to the next belt users need to complete one training session (taking approximately 5 to 10 minutes) and at least three nights of sleep tracking through a sleep diary imbedded in the app, within a 7 day period. Therefore, depending on the frequency of use, participants can take as little as 18 days to progress to “black belt” status, but participants will be given a time frame of 6 weeks to complete the modules.
Parents of participants will have access to a website that provides guidance to assist parents in supporting their child to use Sleep Ninja autonomously and additional resources including information on Sleep Ninja, case examples, and frequently asked questions. Parents of participants allocated to receive the intervention will be provided with the URL for the website alongside instructions on how to download Sleep Ninja. Sleep Ninja is designed to be used individually, at the participants home on a smartphone device. The website is informative only and parents can use it at thier own discretion.

Participants are asked to provide the mobile number they use to sign up to the app as a way for researchers to monitor participant adherence to the intervention through analytics data. We will send an email and sms reminder if the app has not been downloaded within 7 days of study enrolment. After the reminder we will not monitor participants adherence of the intervention until 6 weeks following baseline when we will collect the app analytics data.
Intervention code [1] 331143 0
Treatment: Other
Comparator / control treatment
The comparator is a waitlist control group. Participants in this group will be asked to proceed with their usual sleep management for 6 weeks, after which they will be asked to use Sleep Ninja for 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 341590 0
Feasibility of Sleep Ninja
Timepoint [1] 341590 0
How many participants were recruited to the study will be assessed at 12 weeks post randomisation. How many participants accessed the intervention (downloaded the app) and how many modules were completed will be assessed at 6 weeks post randomisation for the intervention group and 12 weeks post randomisation for the waitlist control group.
Primary outcome [2] 341591 0
Acceptability of Sleep Ninja
Timepoint [2] 341591 0
6 weeks post randomisation for the intervention group and 12 weeks post randomisation for the waitlist control group.
Secondary outcome [1] 448007 0
Insomnia symptoms (child reported)
Timepoint [1] 448007 0
Baseline (week 0), 6 weeks post randomisation and 12 weeks post randomisation.
Secondary outcome [2] 448008 0
Insomnia symptoms (parent reported)
Timepoint [2] 448008 0
Baseline (Week 0), 6 weeks post randomisation, 12 weeks post randomisation.
Secondary outcome [3] 448009 0
Anxiety Symptoms (child reported)
Timepoint [3] 448009 0
Baseline (Week 0), 6 weeks post randomisation, 12 weeks post randomisation.
Secondary outcome [4] 448010 0
Anxiety Symptoms (parent reported)
Timepoint [4] 448010 0
Baseline (Week 0), 6 weeks post randomisation, 12 weeks post randomisation.
Secondary outcome [5] 448011 0
Depressed Mood
Timepoint [5] 448011 0
Baseline (Week 0), 6 weeks post randomisation, 12 weeks post randomisation.
Secondary outcome [6] 448012 0
Self-reported sleep onset latency
Timepoint [6] 448012 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [7] 448013 0
Self reported wake after sleep onset
Timepoint [7] 448013 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [8] 448014 0
Self-reported total sleep time
Timepoint [8] 448014 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [9] 448016 0
Self-reported sleep efficiency
Timepoint [9] 448016 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [10] 448017 0
Objective sleep onset latency
Timepoint [10] 448017 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [11] 448018 0
Objective wake after sleep onset
Timepoint [11] 448018 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [12] 448019 0
Objective total sleep time
Timepoint [12] 448019 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation
Secondary outcome [13] 448020 0
Objective sleep efficiency
Timepoint [13] 448020 0
Baseline (week 0), 6 weeks post randomisation, 12 weeks post randomisation

Eligibility
Key inclusion criteria
To be eligible for inclusion in the study participants must:
1) be between 10 and 16 years of age,
2) live in Western Australia,
3) have not used Sleep Ninja before,
4) will have been previously clinically diagnosed with ASD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic references, including DSM-IV or DSM-5 diagnostic classifications by a health care professional
5) score greater than or equal to 60 on the Social Responsiveness Scale – 2 (SRS-2) and greater than or equal to 15 on the Insomnia Severity Index (ISI) to corroborate an ASD diagnosis and symptoms of clinical insomnia,
6) have access to the internet,
7) have access to a smartphone or tablet for the duration of the intervention and be able to install the Sleep Ninja app
Minimum age
10 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they: 1) have a self-reported diagnosis of severe comorbid sleep disorders other than insomnia (e.g., obstructive sleep apnoea),
2) do not score greater than or equal to 3 on the Single Item Literacy Screener

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be carried out via central randomisation by computer using a secure computer-generated random number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use stratified block randomisation with two strata groups, 10-13 years old and 14-16 years old, followed by a 1:1 block allocation between the intervention and waitlist control.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
4/08/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319040 0
Government body
Name [1] 319040 0
Australian Government Research Training Program (RTP) Scholarship
Country [1] 319040 0
Australia
Primary sponsor type
University
Name
Centre for Sleep Science, University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321527 0
None
Name [1] 321527 0
Address [1] 321527 0
Country [1] 321527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317648 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 317648 0
Ethics committee country [1] 317648 0
Australia
Date submitted for ethics approval [1] 317648 0
02/05/2024
Approval date [1] 317648 0
19/07/2024
Ethics approval number [1] 317648 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141690 0
Dr Jennifer Walsh
Address 141690 0
Centre for Sleep Science, 10-12 Parkway, Crawley, 6009, Western Australia
Country 141690 0
Australia
Phone 141690 0
+61 08 6488 8694
Fax 141690 0
Email 141690 0
[email protected]
Contact person for public queries
Name 141691 0
Jennifer Walsh
Address 141691 0
Centre for Sleep Science, 10-12 Parkway, Crawley, 6009, Western Australia
Country 141691 0
Australia
Phone 141691 0
+61 08 6488 8694
Fax 141691 0
Email 141691 0
[email protected]
Contact person for scientific queries
Name 141692 0
Jennifer Walsh
Address 141692 0
Centre for Sleep Science, 10-12 Parkway, Crawley, 6009, Western Australia
Country 141692 0
Australia
Phone 141692 0
+61 08 6488 8694
Fax 141692 0
Email 141692 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Researchers who provide a methodologically sound proposal with ethics approval will be reviewed on a case-by-case basis, and data shared at the discretion of the Prinicpal Investigator.

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Methodologically sound projects and meta-analyses.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Data will remain available as long as data is stored (in compliance with retention policies).

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting researcher [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.