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Trial registered on ANZCTR


Registration number
ACTRN12618000619246
Ethics application status
Approved
Date submitted
16/04/2018
Date registered
20/04/2018
Date last updated
23/08/2019
Date data sharing statement initially provided
23/08/2019
Date results information initially provided
23/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the Sleeping Sound program on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.
Scientific title
A pilot randomised controlled trial of the Sleeping Sound Intervention on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.
Secondary ID [1] 294605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SSSN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 307429 0
Intellectual Disability 307434 0
Sleep problems 307435 0
Condition category
Condition code
Mental Health 306520 306520 0 0
Autistic spectrum disorders
Mental Health 306521 306521 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents who register their interest in participating in this study will be contacted to complete a screening survey over the phone to determine whether their child is eligible to participate in this study. This phone survey will take approximately 20 mins to complete. If a child is eligible for this study and their parent provides written consent, their parent will be asked to complete an online baseline survey about their child’s autism and sleep, and about the child and family’s wellbeing. This will take about 40 minutes to do. Once the research team has received the survey response, participants will be randomly placed in one of two groups. What the participant does next will depend on which group they are allocated to (usual care or the Sleeping Sound Program intervention- a behavioural sleep intervention)
• Sleeping Sound Program Group
If they are allocated to the Sleeping Sound Program Group, the research team will offer the participant four 50 minute sessions with a clinician who has been trained to help manage children’s sleep problems. The four sessions can be conducted face-to-face, over the phone and/or via Skype.
The first session will be used to gather an understanding of the child's bedtime routine and their parent's goals for their child's sleep. Parents will also be provided with education about good sleep hygiene practices and the importance of a good sleep routine for their children and will be given instructions of how to complete a sleep diary and prepare a behavioural sleep program. The second session will be one week after the first session and will involve discussing the use of the child's behavioural sleep program. The completed sleep diary will also be discussed to identify sleep challenges. Families will then be provided with any of the additional handouts required to assist with the specific sleep difficulties. The third session will happen 2 weeks after the second session to check in on parent's progress and trouble shoot any difficulties. The final session will occur 2 weeks after the third session. This will be used to discuss which strategies are working or not working and to provide parents will final information about sleep strategies and the potential of an 'extinction burst' occurring.
A number of handouts (depending on what the family requires) will be used to help parents with implementing sleep hygiene practices at home. These handouts provide information about specific techniques that can be used to encourage good bedtime routines and how parents can implement these at home. These handouts refer to Bedtime Fading, Bedtime Resistance, Calming Strategies, 'Camping out', Checking Methods, Early Morning Waking Management, Prolonged Night time Awakenings, Sleep Association Management and Rewards. All families will be given an individualised behavioural sleep program for their child to follow at home. This will involve parents taking pictures of their children going through their bedtime routine at home, according to effective sleep hygiene practices discussed with their clinician, and researchers putting this together in a booklet so that the children can see themselves going through their bedtime routine in their own environment. This will be planned in their first session and given to families to use at their second session.
Each of the sessions will be free of charge. All sessions will occur at Deakin University. The research team will then send participants surveys to complete in 3 and 6 months time. Each survey asks about the child’s ASD and sleep, and child and family wellbeing and will take about 40 minutes to fill out. In the survey post intervention sessions, parents will also be asked about their use of the intervention handouts provided by clinicians and also how helpful these handouts were.
Intervention code [1] 300908 0
Behaviour
Intervention code [2] 300931 0
Treatment: Other
Comparator / control treatment
If participants are allocated to the Usual Care Group, they will continue with their usual care procedures. Usual care is defined for the purposes of this study as participants keeping up with their current medication routines, and any appointments (such as paediatricians appointments or therapy sessions) that are part of their regular routine. The research team will then contact the participant again in 3 and 6 months time and ask them to complete surveys about their child’s autism and sleep and child and family wellbeing. Each survey will take about 40 minutes to fill out.
Control group
Active

Outcomes
Primary outcome [1] 305530 0
Parent reports of child sleep problems (measured by the Children's Sleep Habits Questionnaire)
Timepoint [1] 305530 0
To be measured at baseline and at three and six months post randomisation.
Primary outcome [2] 321171 0
A series of custom questions that have been designed specially to evaluate perceptions of the Sleeping Sound program will be used to measure parents thoughts of the sleep program.
Timepoint [2] 321171 0
This will be measured at three months post randomisation for the parents who are allocated to the intervention group.
Secondary outcome [1] 345601 0
The Developmental Behavioural Checklist will be used to measure child behavioural problems.
Timepoint [1] 345601 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [2] 345602 0
The Social Communication Questionnaire- Current form will be used to measure the child’s autism symptomology over time.
Timepoint [2] 345602 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [3] 345603 0
The Strengths and Difficulties questionnaire will be used to measure the child’s behaviour.
Timepoint [3] 345603 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [4] 345605 0
The Child Health Utility 9D will be used to measure child quality of life.
Timepoint [4] 345605 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [5] 345607 0
The Kessler 10 (K10) will be used to measure parent mental health.
Timepoint [5] 345607 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [6] 345609 0
The Assessment of Quality of Life will be used to measure parent quality of life.
Timepoint [6] 345609 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [7] 345736 0
The Developmental Behavioural Checklist will measure children's emotional disturbances.
Timepoint [7] 345736 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [8] 345737 0
The Strengths and Difficulties questionnaire will be used to measure the child’s social functioning.
Timepoint [8] 345737 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [9] 346688 0
The 7-item Sleep Hygiene Scale (study developed measure adapted from the bed routine scales) will be used to measure child’s sleep hygiene.
Timepoint [9] 346688 0
To be measured at baseline and at three and six months post randomisation.
Secondary outcome [10] 346689 0
4 study developed questions comparing child’s coordination, balance and physical activity to same-age peers will be used to measure child motor functioning.
Timepoint [10] 346689 0
To be measured at baseline and at three and six months post randomisation.

Eligibility
Key inclusion criteria
Update
Parents of children who meet the following criteria will be eligible:
* 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 6-13 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) delayed sleep phase disorder AND
• Child has an intellectual disability which will be confirmed by citing a diagnostic/clinical report.
• 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 survey.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if their child has restless leg syndrome or any comorbid medical (e.g., tuberous sclerosis, epilepsy), neuropsychiatric (e.g., Tourette’s) or genetic (e.g., Fragile X disorder) conditions. Non-English speaking families will be excluded. Parents will be excluded if their child has obstructive sleep apnoea.

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)
To enrol a subject, interested parents will register their interest in participating in this study online or over the phone and will be contacted via phone to complete a screening survey to determine whether their child is eligible to participate in this study. This phone survey will take approximately 20 mins to complete. If a child is eligible for this study and their parent provides written consent (online), their parent will be asked to complete an online baseline survey about their child’s autism and sleep, and about the child and family’s wellbeing. This will take about 40 minutes to do. Once the research team has received the survey response, participants will be randomly placed in one of two groups. Randomisation will be generated by a computerised sequence loaded into the REDCap online platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Our sample size will consist of parents of 40 children. We calculated a power analysis and found that to find a medium effect size (0.35) we will require a total sample size of 38, therefore our anticipated sample size of 40 will meet this requirement. We envisage that 40 participants will provide enough power to see trends to warrant a larger RCT investigation. This sample size is also aligned with a similar pilot RCT study which included 27 participants (Sciberras et al., 2011). We plan to analyse group differences across outcomes such as child sleep problems, quality of life and parent mental health between participants who receive and don’t receive the intervention to determine the effectiveness of the Sleeping Sound intervention program for children with ASD+ID. We plan to analyse a series of feedback questions previously used to determine the feasibility of and satisfaction with the program according to parent report.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299224 0
University
Name [1] 299224 0
Faculty of Health, Deakin University
Address [1] 299224 0
221 Burwood Highway, Burwood, 3125, VIC
Country [1] 299224 0
Australia
Primary sponsor type
Individual
Name
Dr Nicole Papadopoulos
Address
221 Burwood Highway, Burwood, 3125, VIC
Country
Australia
Secondary sponsor category [1] 298494 0
None
Name [1] 298494 0
Address [1] 298494 0
Country [1] 298494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300147 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300147 0
221 Burwood Highway, Burwood, 3125, VIC
Ethics committee country [1] 300147 0
Australia
Date submitted for ethics approval [1] 300147 0
06/07/2017
Approval date [1] 300147 0
26/09/2017
Ethics approval number [1] 300147 0
2017-207

Summary
Brief summary
ASD is a prevalent neurodevelopmental disorder associated with serious adverse outcomes, which compromises the individual’s life chances and productivity. Up to 80% of children with ASD experience sleep problems, with these sleep problems exacerbating existing impairments. Treating sleep problems in children with ASD is associated with markedly improved functioning, including improvements in the core symptoms of ASD. To date, sleep interventions for ASD are largely based on research conducted in samples of children with ASD who are intellectually able. There is a gap in services available for children with ASD with an intellectual disability. We now plan to extend the Sleeping Sound program for children with ASD who also have an intellectual disability, with the ultimate goal of using this intervention to improve outcomes for the entire autism spectrum. The development of such program will represent a major treatment breakthrough for children with ASD with an intellectual disability. The proposed study will also result in a significant advance in the treatment of sleep problems in children with developmental disabilities.
It is hypothesised that the Sleeping Sound program will be acceptable and feasible to parents of children with ASD+ID and that the following benefits will be observed in comparison to a treatment as usual comparison group:
1. Reduced sleep problems
2. Fewer social-communication symptoms, emotional/behavioural disturbance
3. Improved quality of life
4. Improved parent mental health.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82702 0
Dr Nicole Papadopoulos
Address 82702 0
Deakin University. 221 Burwood Highway, Burwood, 3125, VIC
Country 82702 0
Australia
Phone 82702 0
+61 3 9244 5295
Fax 82702 0
Email 82702 0
nicole.papadopoulos@deakin.edu.au
Contact person for public queries
Name 82703 0
Dr Nicole Papadopoulos
Address 82703 0
Deakin University. 221 Burwood Highway, Burwood, 3125, VIC
Country 82703 0
Australia
Phone 82703 0
+61 3 9244 5295
Fax 82703 0
Email 82703 0
nicole.papadopoulos@deakin.edu.au
Contact person for scientific queries
Name 82704 0
Dr Nicole Papadopoulos
Address 82704 0
Deakin University. 221 Burwood Highway, Burwood, 3125, VIC
Country 82704 0
Australia
Phone 82704 0
+61 3 9244 5295
Fax 82704 0
Email 82704 0
nicole.papadopoulos@deakin.edu.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary