Sleeping Sound Community Trial: A waitlist randomized controlled trial of a brief behavioural sleep intervention program for autistic children aged 5-13 years

Not Applicable

Conditions: Autism spectrum disorder
Mental Health - Autistic spectrum disorders
Behavioural sleep problem
Public Health - Other public health

Registration Number: ACTRN12624000399594

Lead Sponsor: Monash University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 120

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

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

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parent report of child sleep problem at 3 month follow up[Total Children's Sleep Habits Questionnaire score 3 months post randomisation]

Secondary Outcome Measures

Name	Time	Method
Sleep: Parent report of specific child sleep patterns[Children's Sleep Habits Questionnaire subscale scores 3 and 6 months post randomisation];Children's level of emotional and behavioural functioning (composite)[Strengths and Difficulties Questionnaire, Conners-4 3 and 6 months post randomisation];Parent or caregiver mental health[Kessler 10 3 and 6 months post randomisation];Child autism symptoms (composite)[Social Responsiveness Scale - 2 3 and 6 months post-randomisation];Parent report of child sleep problem at 6 month follow up[Total Children's Sleep Habits Questionnaire score 6 months post-randomisation];Parent or caregiver stress[Parenting Stress Index 3 and 6 months post-randomisation]