None listed
Conditions
Brief summary
This study aims to investigate the feasibility, acceptibility and preliminary effectiveness of a Cognitive Behavioural Therapy for Insomnia smartphone application (called Sleep Ninja®) for improving sleep in autistic adolescents (aged 10 to 16 years) with insomnia. Specifically, we aim to: 1) Evaluate the feasibility of Sleep Ninja through examining recruitment rates, intervention completion rates, reasons for non-adherence and participant retention. 2) Qualitatively assess acceptability, utility, appropriateness and suitability of Sleep Ninja 3) Conduct a preliminary examination of the effects of Sleep Ninja on sleep outcomes including insomnia symptoms, total sleep time, wake after sleep onset, sleep efficiency and time spent in bed, as measured objectively via actigraphy and sleep EEG and subjectively via questionnaires and sleep diaries. It is hypothesised that the digital sleep application (Sleep Ninja) will be a feasible sleep intervention as indicated by high uptake, completion, and retention rates, and that the app will be acceptable to adolescents, and its use will suggest improvement in sleep outcomes.
Interventions
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)
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.
Sponsors
Centre for Sleep Science, University of Western Australia
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
10 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for inclusion in the study participants must: 1) be between 10 and 16 years of age, 2) live in 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 15 on the Insomnia Severity Index (ISI) to demonstrate 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
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, and parents confirm the participant has literacy difficulties
Outcome results
None listed