Condition category
Mental and Behavioural Disorders
Date applied
03/03/2017
Date assigned
13/03/2017
Last edited
24/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Autism Spectrum Disorder (ASD) is a disorder characterised by severe and persistent social, communication, and behavioural problems. Individuals with ASD are at great risk of emotional and behavioural problems during childhood, and, as adults, have poor mental health and occupational functioning outcomes. Children with ASD often suffer from sleep problems, such as difficulty falling asleep, resisting going to bed and being tired in the morning. Sleep disturbance has been shown to cause anxiety and behavioural problems in children with ASD. Despite the promise of behavioural sleep interventions for children with ASD, few studies have examined their efficacy in this condition. Up to 85% of children with ASD experience sleep problems, compared to 20-30% of children in the general population. A previous small study run by the Royal Children’s Hospital (Australia) in 2013 found that a programme that includes two or three sleep sessions with a trained staff helped children with ASD improve their sleep problems, wellbeing and daily functioning. This study aims to investigate whether a larger group of children with ASD may benefit from this treatment by comparing children who receive the programme with children who do not.

Who can participate?
Families of children aged 5-12 years and children who have turned 13 and who are attending Primary School (all genders).

What does the study involve?
Parents are contacted about the study to see if their child is eligible. This involves asking questions about their child’s autism symptoms, wellbeing and daily functioning. If eligible to take part, they complete a survey which includes questions about their child’s autism, sleeping problems, and about their child and family’s wellbeing. Participants are then randomly allocated to one of two groups. Those in the first group are included in the sleep programme which involves attending two 50 minute face-to-face sessions and a follow up phone call with a psychologist or paediatrician who has been trained to help manage sleep problems two weeks after the sessions. At the sleep sessions, the psychologist assesses the child’s sleep and provides parents with some strategies to help manage their child’s sleep. Those in the second group continue with care as usual and do not attend the intervention sessions. At six months all parents are asked to bring their child in for a learning assessment. Additionally, both groups are asked to complete surveys at three, six and 12 months after treatment. With the families consent, the participants’ school teacher is asked to complete surveys at the start of the study, and at the three, six and 12 months follow up.

What are the possible benefits and risks of participating?
Participants may benefit from the strategies and information provided about managing sleep problems. There are no notable risks with participating.

Where is the study run from?
1. Deakin University Melbourne Campus (Australia)
2. The Royal Children’s Hospital (Australia)

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
Australian National Health and Medical Research Centre (Australia)

Who is the main contact?
Professor Nicole Rinehart
nicole.rinehart@deakin.edu.au

Trial website

http://www.sleepingsoundASD.com.au

Contact information

Type

Public

Primary contact

Miss Susannah Bellows

ORCID ID

Contact details

Deakin University Burwood
L5 BC Building
221 Burwood Highway
Melbourne
3125
Australia
+61 3 9246 8471
sleepingsound@deakin.edu.au

Type

Scientific

Additional contact

Prof Nicole Rinehart

ORCID ID

Contact details

Deakin University Burwood
L5 BC Building
221 Burwood Highway
Melbourne
3125
Australia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36154A

Study information

Scientific title

Tailoring a brief sleep intervention for autism spectrum disorder: a randomised controlled trial

Acronym

SSASD

Study hypothesis

Children with ASD who receive the Sleeping Sound intervention will show reductions in sleeping problems, emotional and behavioural problems, social-communicative symptoms, as well as increased cognitive and academic performance and quality of life post intervention compared to children who receive treatment as usual. It is further hypothesised that parents of children who receive the intervention will have decreased parent mental health symptoms than those who receive treatment as usual, and that the Sleeping Sound intervention will be cost-effective compared to the usual treatment.

Ethics approval

Royal Children's Hospital Human Research Ethics Committee, 22/07/2016, ref: HREC/16/RCHM/73

Study design

Multi-site randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet’

Condition

Autism Spectrum Disorder

Intervention

Parents are contacted about the project and to see if their child is eligible for the project. This involves asking questions about their child’s autism symptoms, wellbeing and daily functioning. If eligible to take part, they complete a survey about their child’s autism and sleep, and about their child and family’s wellbeing. Upon receiving the completed consent form and baseline survey, families are randomised to either the behavioural sleep intervention group or the comparison group. Treatment allocation is determined sequentially, according to a computer-generated block randomisation sequence, with blocks of randomly varying size. Given the relatively fewer diagnoses of Autism Spectrum Disorder (ASD) among girls, randomisation is stratified by gender to ensure equal representation of girls in both study arms.

1. Behavioural sleep intervention (intervention group):
Participants in the intervention group are offered two 50 minute face-to-face, fortnightly sleep consultations, with a further follow up phone call two weeks with a trained psychologist or paediatrician after the consultations. The intervention is delivered by trained study-employed clinicians with experience working with children with ASD. These visits are free of charge. During the first consultation, the clinician assesses the child's sleep problem, elicit parent goals for sleep management, provide information about normal sleep, sleep cycles, and sleep hygiene strategies, and formulate a behavioural sleep management plan tailored to the child's sleep problem. Parents are asked to complete a sleep diary between the first and second consultation. The second consultation and follow-up phone call are used to review the sleep diary, reinforce suggested strategies and troubleshoot any problems encountered.

2. Usual care (control group):
Participants in the control group are able to access the usual care for ASD from their child's paediatrician and/or other health services.

At six months all parents are asked to bring their child in for a learning assessment. All families complete surveys at baseline and then again at three, six and 12 months follow up time points post-randomisation. With families consent, the participants’ school teacher is asked to complete surveys at the start of the study, and at three, six and 12 months follow up. The National Assessment Program — Literacy and Numeracy (NAPLAN) results for the child are accessed to review educational outcomes, as well as the child’s Medicare records are accessed in order assess which health services they have used.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Parent reports of child sleep problem are measured by the Child Sleep Habits Questionnaire at baseline, three, six, and 12 months.

Secondary outcome measures

Child secondary outcome measures:
1. Emotional and behavioural problems are measured using parent and teacher reports at baseline, three, six and 12 months
2. Social-communicative symptoms are measured using parent and teacher reports at baseline, three, six and 12 months
3. Cognitive and academic performances are measured using blinded and direct assessments at six months
4. Quality of life is measured using parent reports at baseline, three, six and 12 months

Parent secondary outcome measures:
1. Parent mental health symptoms are measured using K10 (Kessler 10) at baseline, three, six and 12 months
2. Parent stress is measured using the PSI-4-SF (Parenting stress index, fourth edition, short form) at baseline, three, six and 12 months

Economic outcome measure:
1. Cost-effectiveness of the intervention is measured using a cost-utility and cost-consequence analysis (based from parent reports) at baseline, three, six and 12 months

Overall trial start date

01/01/2016

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 18/10/2017:
1. Families of children aged 5-12 years (all genders) (13 years if attending primary school)
2. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM-5). A SCQ cut off score of >= 11 will be used
3. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013): chronic insomnia (including problems of initiating and maintaining sleep, sleep-onset association, limit-setting, and anxiety-related insomnia), delayed sleep-wake phase or parasomnias (including nightmares, sleep terrors and sleepwalking)

Previous inclusion criteria:
1. Families of children aged 5-12 years (all genders)
2. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM-5).
3. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013): chronic insomnia (including problems of initiating and maintaining sleep, sleep-onset association, limit-setting, and anxiety-related insomnia), delayed sleep-wake phase or parasomnias (including nightmares, sleep terrors and sleepwalking)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

The target number of participants to recruit into the study is 234 (117 randomised to intervention, 117 randomised to control).

Participant exclusion criteria

Current exclusion criteria:
1. Intellectual disability
2. Have comorbid medical that affect sleep (e.g. nocturnal seizures, blindness), or syndromic genetic (e.g. Fragile X) conditions
3. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician
4. Non-English speaking

Previous exclusion criteria:
1. Intellectual disability
2. Have comorbid medical (e.g. epilepsy), neuropsychiatric (e.g. Tourette's) or syndromic genetic (e.g. Fragile X) conditions
3. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician
4. Non-English speaking

Recruitment start date

01/04/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Australia

Trial participating centre

Deakin University
221 Burwood Highway Burwood Victoria
Melbourne
3125
Australia

Trial participating centre

The Royal Children's Hospital
50 Flemington Road Parkville VIC
Melbourne
3052
Australia

Sponsor information

Organisation

The Royal Children’s Hospital

Sponsor details

The Royal Children's Hospital
Flemington Road
Parkville
Melbourne
3052
Australia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Australian National Health and Medical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed medical journal and planned presentations at local and international conferences.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Susannah Bellows sleepingsound@deakin.edu.au

Intention to publish date

01/07/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: Added trial website. 19/10/2017: The inclusion and exclusion criteria has been updated.