Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000399594
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleeping Sound Community Trial: A waitlist randomized controlled trial of a brief behavioural sleep intervention program for autistic children aged 5-13 years
Scientific title
Sleeping Sound Community Trial: A waitlist randomized controlled trial to assess the efficacy of a brief behavioural sleep intervention program for autistic children aged 5-13 years
Secondary ID [1] 311615 0
nil
Universal Trial Number (UTN)
Trial acronym
SSASD Community
Linked study record
This study relates to ACTRN12618000619246. It involves scaling the intervention to a community clinic context.

Health condition
Health condition(s) or problem(s) studied:
Autism spectrum disorder 333036 0
Behavioural sleep problem 333037 0
Condition category
Condition code
Mental Health 329720 329720 0 0
Autistic spectrum disorders
Public Health 329721 329721 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Sleeping Sound intervention involves two 50-minute face-to-face sessions and a follow-up phone call at 2 week intervals delivered by a clinician (e.g., Paediatrician or Psychologist or Provisional Psychologist), experienced in working with autistic children. The first session will focus on assessing specific sleep difficulties that the child is experiencing and setting goals in relation to the specific sleep problems. Families will be provided with psychoeducation in relation to sleep hygiene and normal sleep patterns, and a tailored sleep management plan that includes their agreed upon goals and tailored sleep management techniques. Examples of the behavioural sleep management techniques that may be individually tailored to participants include bedtime fading to treat delayed sleep phase and early morning rising, relaxation techniques for sleep anxiety, primary caregivers ‘camping out’ for sleep onset association disorder, and parent management techniques (such as enforcing boundaries) that may be coupled with a reward system for bedtime resistance. Sleep management strategies may be delivered using a range of study designed visual tools (e.g., visual sleep schedules, social scripts etc.) to reinforce learning. Families will be given a sleep diary and asked to record bed time, sleep time, wake time and any night time awakenings for the two weeks following the first face-to-face session. Clinicians will keep a study consultation form of the session to document precipitating, predisposing, and perpetuating factors impacting the child’s sleep problems, which includes bedtime routines, sleep environment, medications and co-morbid psychological disorders. The second session is held two weeks later and will be used to reinforce sleep strategies, monitor sleep patterns (by reviewing a sleep diary), and to troubleshoot any difficulties that the family may be experiencing. This will involving reviewing the sleep diary completed over the preceding period and discussing the use of the strategies recommended in the first session. These details, alongside any new strategies recommended and other relevant clinical information will be recorded. A follow up phone call (< 30 minutes) will then be made to the family two weeks later to provide further support and an opportunity to reinforce strategies. Again, there will be an opportunity to review the sleep diary, discuss strategies used, and to update the clinical/intervention record.
The clinicians will receive training in the intervention prior to commencing sessions and participate in regular supervision sessions.
Intervention code [1] 328069 0
Behaviour
Comparator / control treatment
Upon receipt of consent and completion of the baseline surveys, families will be randomised by a researcher independent of the project, to either the Sleeping Sound intervention or the wait list (control) group. The control group will be invited to receive the intervention following 3-month follow-up surveys.
Control group
Active

Outcomes
Primary outcome [1] 337517 0
Parent report of child sleep problem at 3 month follow up
Timepoint [1] 337517 0
3 months post randomisation
Secondary outcome [1] 432175 0
Sleep: Parent report of specific child sleep patterns
Timepoint [1] 432175 0
3 and 6 months post randomisation
Secondary outcome [2] 432176 0
Children's level of emotional and behavioural functioning (composite)
Timepoint [2] 432176 0
3 and 6 months post randomisation
Secondary outcome [3] 432177 0
Parent or caregiver mental health
Timepoint [3] 432177 0
3 and 6 months post randomisation
Secondary outcome [4] 432179 0
Child autism symptoms (composite)
Timepoint [4] 432179 0
3 and 6 months post-randomisation
Secondary outcome [5] 433357 0
Parent report of child sleep problem at 6 month follow up
Timepoint [5] 433357 0
6 months post-randomisation
Secondary outcome [6] 433529 0
Parent or caregiver stress
Timepoint [6] 433529 0
3 and 6 months post-randomisation

Eligibility
Key inclusion criteria
Child is autistic and aged 5-13 years AND
Having a moderate or severe sleep problem by parent report and need to meet criteria for at least one of the following behavioural sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria: chronic insomnia (due to problems of sleep onset association, limit setting, prolonged night time waking, primary insomnia, early waking, or anxiety) or delayed sleep phase disorder AND
• Child has not been diagnosed with an intellectual disability on parent report
• Living in Victoria
Participants currently taking melatonin as well as any other medications (SSRI’s etc.) will be included in the trial, if they continue to meet the above eligibility criteria. Information regarding medication will be collected as part of the parent survey.

Parent/caregiver eligibility requirements:
• Parent/caregiver of child who meets child eligibility requirements AND
• Living in Victoria, Australia AND
• Have sufficient English proficiency to provide informed consent and answer online questionnaires
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have any comorbid medical (e.g., tuberous sclerosis, nocturnal seizures, blindness), neuropsychiatric (e.g., Tourette’s) or genetic (e.g., Fragile X disorder) conditions associated with intellectual disability or disturbing regular sleep patterns.
Children with suspected obstructive sleep apnoea (OSA) will be identified using 3 OSA items from the Child Sleep Habits Questionnaire. If a parent endorses snoring usually or sometimes and one of the other two items of the OSA screening questions as usually or sometimes), that child will be referred to a paediatric fellow for a follow up assessment sleep apnoea. If the child is determined to have sleep apnoea from this assessment, they will be excluded from the research study and referred to their paediatrician for treatment.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician independent to this study will randomise participants using a computer generated randomisation sequence with 1:1 ratio between groups and blocks of four, six, and eight in size stratified by gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted on an intention-to-treat basis. The mean difference in primary and secondary outcomes between the intervention and wait list control groups at the 3- and 6-month post-randomisation time points will be carried out using linear mixed effects regression with results presented as mean differences (and 95% CIs). Analyses will also be run adjusting for baseline functioning and potentially confounding a priori variables. Given the proof-of-principle nature of this study, it will focus on effect sizes (Cohen’s d) rather than statistical significance testing. If the sample size recruited is not sufficiently powered to conduct this analysis, a mixed ANOVA will be conducted and not adjusted for covariates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315923 0
University
Name [1] 315923 0
Monash Krongold Clinic
Country [1] 315923 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318076 0
None
Name [1] 318076 0
Address [1] 318076 0
Country [1] 318076 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314769 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314769 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 314769 0
Australia
Date submitted for ethics approval [1] 314769 0
13/11/2023
Approval date [1] 314769 0
02/01/2024
Ethics approval number [1] 314769 0
40102

Summary
Brief summary
This study aims to evaluate the efficacy of a brief behavioural sleep program (Sleeping sound) in reducing children's sleep problems and emotional behavioural disturbance and parents functioning and wellbeing in a sample of primary school aged autistic children with sleep problems, within a community clinic context.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132670 0
Dr Nicole Papadopoulos
Address 132670 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800
Country 132670 0
Australia
Phone 132670 0
+61 3 99059173
Fax 132670 0
Email 132670 0
nicole.papadopoulos@monash.edu
Contact person for public queries
Name 132671 0
Nicole Papadopoulos
Address 132671 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800
Country 132671 0
Australia
Phone 132671 0
+61 3 99059173
Fax 132671 0
Email 132671 0
nicole.papadopoulos@monash.edu
Contact person for scientific queries
Name 132672 0
Nicole Papadopoulos
Address 132672 0
Monash University, Faculty of Education, 19 Ancora Imparo Way, Clayton, 3800
Country 132672 0
Australia
Phone 132672 0
+61 3 99059173
Fax 132672 0
Email 132672 0
nicole.papadopoulos@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Some data may be identifiable and health related


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.