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Trial registered on ANZCTR


Registration number
ACTRN12621001194853
Ethics application status
Approved
Date submitted
19/07/2021
Date registered
6/09/2021
Date last updated
6/09/2021
Date data sharing statement initially provided
6/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Children on the Autism Spectrum
Scientific title
A Randomised Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Children on the Autism Spectrum
Secondary ID [1] 304004 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism 321621 0
Insomnia 321622 0
Condition category
Condition code
Mental Health 319364 319364 0 0
Autistic spectrum disorders
Mental Health 319365 319365 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following enrollment in the study, participants will be randomly allocated to either the CBTi or a waitlist control group. Random allocation to condition will be achieved using a computer-generated permuted block schedule. This computerised randomised scheduling will ensure even numbers of participants across the two groups, and ensures the researchers are blind to treatment allocation as this occurs before participants enter the study). All eligible families will be provided with the materials for their baseline week, including a sleep diary and questionnaires. CBTi will be delivered by a registered or provisional psychologist and will include three manualised 1-hour therapy sessions, based on readily available clinical resources, which will be conducted via telehealth. Sessions will occur once per week on a set day. These sessions will address:

(1) sleep education (children’s sleep needs, the stages of sleep, sleep homeostasis) and sleep hygiene (practices and habits that support good sleep, such as a bedtime routine, avoiding caffeine and stimulants, and having a quiet and dark bedroom environment) (Paine & Gradisar, 2011);
(2) sleep restriction therapy (restricting time in bed to baseline total nightly sleep duration for one week by shifting bedtimes later) (Spielman, Yang & Glovinsky, 2011);
(3) graduated exposure (Rapee, Wignall, Hudson, & Schniering, 2000) to night-time separation from parent (including rewards for successful achievements and practice) and relaxation and coping self-talk.

Therapists will use a checklist to indicate attendance and topics covered for each session, which will be reviewed by the chief investigator.

The sleep diary is a readily available resource (Carney et al., 2012). The sleep diary is a daily log of the sleep of the participant, including information about bedtime, sleep onset latency, wake after sleep onset and sleep duration. The sleep diary takes less than 5 minutes to complete each day. The one-week sleep diary will be used at baseline, each week following the treatment sessions, at post-intervention and at one-month follow up.

Wrist actigraphy will not be used in this study.
Intervention code [1] 320314 0
Treatment: Other
Intervention code [2] 321332 0
Behaviour
Comparator / control treatment
The waitlist control group will be offered the intervention after the one month intervention period.
Control group
Active

Outcomes
Primary outcome [1] 328480 0
Average sleep onset latency, calculated from the sleep diary
Timepoint [1] 328480 0
Baseline, post-intervention, one-month follow-up. All post-intervention outcomes will be administered immediately after the participant completes the final intervention activity
Primary outcome [2] 328481 0
Average sleep duration, calculated from the sleep diary
Timepoint [2] 328481 0
Baseline, post-intervention, one-month follow up. Post-intervention occurs immediately after the participant completes the final intervention activity.
Primary outcome [3] 328482 0
Average wake after sleep onset, calculated from the sleep diary
Timepoint [3] 328482 0
Baseline, post-intervention, one-month follow up. Post-intervention occurs immediately after the participant completes the final intervention activity.
Secondary outcome [1] 398461 0
SCARED- Child Report assesses self-reported anxiety of the child
Timepoint [1] 398461 0
Pre- and post-intervention (immediately after the participant completes the final intervention activity)
Secondary outcome [2] 398462 0
SCARED - Parent-report assesses the anxiety of the child using parent-report
Timepoint [2] 398462 0
Pre- and post-intervention (immediately after the participant completes the final intervention activity)
Secondary outcome [3] 398463 0
DASS-21 Parent report assesses the level of psychological distress in the primary caregiver
Timepoint [3] 398463 0
Pre- and post-intervention (immediately after the participant completes the final intervention activity)
Secondary outcome [4] 398464 0
Short Mood and Feelings Questionnaire is a child self-report of depressed mood
Timepoint [4] 398464 0
Pre- and post-intervention (immediately after the participant completes the final intervention activity)
Secondary outcome [5] 398465 0
Paediatric Daytime Sleepiness Scale is a child=reported measure of daytime sleepiness
Timepoint [5] 398465 0
Pre- and post-intervention (immediately after the participant completes the final intervention activity)

Eligibility
Key inclusion criteria
Diagnoses of autism and insomnia. The inclusion criteria for families is that one parent/care-giver has basic written and spoken English
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual disability for the child. If the parent of care-giver does not have spoken and written English proficiency to the level that they are able to complete study measures and support the child during therapy sessions.

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 involved contacting the holder of the allocation schedule who was "off-site" and not involved in determining eligibility
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori sample size estimation using G*Power 3.1 was used (alpha = .05, power level of 0.80 as per Paine and Gradisar, 2011) to calculate the number of participants required to detect a medium Cohen's d effect size of 0.5 for sleep and daytime functioning. It was estimated that 44 participants were required, 22 in each group.
Data will be analysed using linear mixed models and reliable change indices to detect clinically significant change.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/05/2021
Date of last participant enrolment
Anticipated
30/08/2022
Actual
Date of last data collection
Anticipated
30/10/2022
Actual
Sample size
Target
60
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308385 0
Charities/Societies/Foundations
Name [1] 308385 0
Channel 7 Children's Research Foundation
Country [1] 308385 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Road, Bedford Park, SA 5041
Country
Australia
Secondary sponsor category [1] 309214 0
None
Name [1] 309214 0
Address [1] 309214 0
Country [1] 309214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308350 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 308350 0
Sturt Road, Bedford Park, SA 5041
Ethics committee country [1] 308350 0
Australia
Date submitted for ethics approval [1] 308350 0
10/02/2021
Approval date [1] 308350 0
16/02/2021
Ethics approval number [1] 308350 0
Project ID: 4038

Summary
Brief summary
Autism is a lifelong neurodevelopmental disorder characterised by differences in social communication, repetitive and restricted behaviours and sensitivities to sensory input (Diagnostic and Statistical Manual of Mental Disorders 5th ed: DSM-5; APA, 2013). Along with autism symptomology, autism is linked to a greater incidence of insomnia, with the prevalence estimated at 60- 86% in school aged children, compared to 5-30% among their non-autistic peers (Paine & Gradisar, 2011; Papadopoulos et al., 2019; Liu et al., 2006). Consequences of poor sleep include behavioural problems, impaired adaptive behaviour, psychopathology and exacerbated autism symptomology (Paine & Gradisar, 2011; Papadopoulos et al., 2019). Resultingly, effective treatment for insomnia is imperative in order to reduce negative consequences.

Cognitive Behavioural Therapy for insomnia (CBTi) is recommended as a primary treatment for insomnia (American Academy of Sleep, 2005) and has demonstrated efficacious outcomes (Quaseem et al., 2016). However, there is scant research on CBTi as a treatment for insomnia among individuals with autism, with the majority of studies focusing on pharmaceutical options (Cortesi et al., 2012). Therefore, the present study aims to establish the efficacy of Cognitive Behaviour Therapy for Insomnia (CBTi) in children aged 7-12 with autism, compared to a waitlist control group of children aged 7-12 with autism.

Hypotheses

Children who receive CBTi will have significantly greater improvements in sleep parameters including sleep onset latency, wake after sleep onset, sleep duration and sleep efficiency compared to a waitlist controlled autistic group.

Additionally, children who receive CBTi will have significantly greater improvements in anxiety, depression and daytime sleepiness compared to the waitlist controlled autistic group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110406 0
Dr Michelle Short
Address 110406 0
Flinders University, Social Sciences North, Level 3, Sturt Road, Bedford Park, SA 5041
Country 110406 0
Australia
Phone 110406 0
+61 419 834 340
Fax 110406 0
Email 110406 0
[email protected]
Contact person for public queries
Name 110407 0
Michelle Short
Address 110407 0
Flinders University, Social Sciences North, Level 3, Sturt Road, Bedford Park, SA 5041
Country 110407 0
Australia
Phone 110407 0
+61 419 834 340
Fax 110407 0
Email 110407 0
[email protected]
Contact person for scientific queries
Name 110408 0
Michelle Short
Address 110408 0
Flinders University, Social Sciences North, Level 3, Sturt Road, Bedford Park, SA 5041
Country 110408 0
Australia
Phone 110408 0
+61 419 834 340
Fax 110408 0
Email 110408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results, after de-identification
When will data be available (start and end dates)?
Data will be available on December 1, 2022. No end date determined
Available to whom?
Access will be determined on a case-by-case basis at the discretion of the Chief Investigator
Available for what types of analyses?
Not limited to any specific type of analyses
How or where can data be obtained?
Access subject to approvals by Chief Investigator, Dr Michelle Short. Contact via email: [email protected]


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.