Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001276943
Ethics application status
Approved
Date submitted
17/09/2020
Date registered
26/11/2020
Date last updated
11/01/2024
Date data sharing statement initially provided
26/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth Sleeping Sound ASD: A pilot study evaluating the telehealth delivery of a brief behavioural sleep intervention for autistic children.
Scientific title
Telehealth Sleeping Sound ASD: A pilot feasibility and acceptability randomized control trial of a brief behavioural sleep intervention program for autistic children aged 5-12 years.
Secondary ID [1] 301906 0
Nill known
Universal Trial Number (UTN)
U1111-1256-2161
Trial acronym
TelehealthSSASD Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 318417 0
Sleep problems 319109 0
Condition category
Condition code
Mental Health 316426 316426 0 0
Autistic spectrum disorders
Public Health 317068 317068 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), 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. A follow up phone call will then be made to the family two weeks later to provide further support and an opportunity to reinforce strategies.
Intervention code [1] 318192 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 usual care (control) group. The treatment as usual (TAU) comparison group will receive standard services and support currently available in the community and the same assessment follow-up protocol. There are currently no “standard” services/interventions available in Australia for autistic children who have sleep disorders. Web-based ‘tip sheets’ are available on the topic of ASD sleep management, but these are of a variable quality.
Control group
Active

Outcomes
Primary outcome [1] 324579 0
Feasability and acceptability of the Telehealth Sleeping Sound ASD intervention. This will be assessed using parent reports of the helpfulness/usefulness of the intervention and use of program strategies using a study-designed questionnaire provided to families in the intervention group three months post randomisation.
Timepoint [1] 324579 0
3 months post randomisation
Secondary outcome [1] 385013 0
Children's sleep problems measured using the Children's sleep habits questionnaire.
Timepoint [1] 385013 0
3 and 6 months post randomisation
Secondary outcome [2] 385014 0
Children's level of emotional and behavioural functioning measured using the developmental behavioural checklist 2 (DBC2) (composite secondary outcome)
Timepoint [2] 385014 0
3 and 6 months post randomisation
Secondary outcome [3] 385015 0
Children's quality of life measured using the Child Health Utility- 9D (CHU-9D)
Timepoint [3] 385015 0
3 and 6 months post randomisation
Secondary outcome [4] 385016 0
Parent/caregiver mental health measured using the Kessler 10 (K10)
Timepoint [4] 385016 0
3 and 6 months post randomisation
Secondary outcome [5] 388336 0
Children's sleep hygiene measured using a 7-item sleep hygiene scale
Timepoint [5] 388336 0
3 and 6 months post randomisation
Secondary outcome [6] 388337 0
Parent/caregiver quality of life measure using the AQol4D
Timepoint [6] 388337 0
3 and 6 months post randomisation

Eligibility
Key inclusion criteria
Eligibility requirements for child:
• Multidisciplinary diagnosis of DSM-IV Autistic Disorder, Asperger’s Disorder or DSM-5 ASD, as indicated by paediatrician or a confirmed diagnosis as cited in a clinical report AND
• Aged 5-12 years AND
• A score above the clinical cut off (11 or more) on the Social Communication Questionnaire Lifetime form (10 minutes completion time) 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 Australia
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)
Participants will be randomised using a concealed computer generated randomisation sequence.
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 two in size stratified by biological sex. .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a small pilot trial to determine the feasibility and acceptability of delivering the Sleeping Sound intervention via telehealth. We hope to subsequently trial the intervention in a larger RCT. For the current pilot, we require 60 families (30 intervention, 30 usual care).

Analyses will be conducted on an intention-to-treat basis. Descriptive statistics will be used to summarize the acceptability and feasibility of the intervention. The mean difference in secondary outcomes (child sleep problems, child emotional and behavioural problems child quality of life, parent mental health, parent quality of life) between the TAU and intervention 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 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2022
Actual
3/11/2022
Date of last participant enrolment
Anticipated
1/02/2023
Actual
18/04/2023
Date of last data collection
Anticipated
31/03/2023
Actual
2/10/2023
Sample size
Target
60
Accrual to date
Final
61
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306320 0
Government body
Name [1] 306320 0
Australian Government
Country [1] 306320 0
Australia
Funding source category [2] 315555 0
Charities/Societies/Foundations
Name [2] 315555 0
J & S Wenig
Country [2] 315555 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University Clayton Campus, 19 Ancora Imparo Way, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 306817 0
None
Name [1] 306817 0
Address [1] 306817 0
Country [1] 306817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306533 0
Monash University Human Research Ethics Commitee
Ethics committee address [1] 306533 0
Ethics committee country [1] 306533 0
Australia
Date submitted for ethics approval [1] 306533 0
15/03/2022
Approval date [1] 306533 0
11/04/2022
Ethics approval number [1] 306533 0
MUHREC 31626

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

Contacts
Principal investigator
Name 104190 0
Dr Nicole Papadopoulos
Address 104190 0
Monash University
School of Educational Psychology and Counselling
Faculty of Education
19 Ancora Imparo Way
Clayton VIC 3800
Australia
Country 104190 0
Australia
Phone 104190 0
+61 3 99055690
Fax 104190 0
Email 104190 0
[email protected]
Contact person for public queries
Name 104191 0
Nicole Papadopoulos
Address 104191 0
Monash University
School of Educational Psychology and Counselling
Faculty of Education
19 Ancora Imparo Way
Clayton VIC 3800
Australia
Country 104191 0
Australia
Phone 104191 0
+61 3 99055690
Fax 104191 0
Email 104191 0
[email protected]
Contact person for scientific queries
Name 104192 0
Nicole Papadopoulos
Address 104192 0
Monash University
School of Educational Psychology and Counselling
Faculty of Education
19 Ancora Imparo Way
Clayton VIC 3800
Australia
Country 104192 0
Australia
Phone 104192 0
+61 3 99055690
Fax 104192 0
Email 104192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.