None listed
Conditions
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.
Interventions
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. Thi
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.
Sponsors
Dr Nicole Papadopoulos
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Healthy volunteers
No
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.
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.
Outcome results
None listed