Inclusion criteria for families with an autistic child

In order to take part in this study you and your family need to meet the following criteria:

• Give informed consent (for adults) or assent (for children) to take part in the study
• Have one child aged 5-14 years old on the 01/06/2025 with a clinical diagnosis of autism according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or International Classification of Diseases 11th revision (ICD-11) diagnostic criteria for autism. This diagnosis must be verified by a clinical report (relevant assessments can include clinical observations, caregiver history, self-report, behavioural assessments, Autism Diagnostic Observation Schedule (ADOS), and Autism Diagnostic Interview – Revised (ADI-R)). These reports will be reviewed by a psychiatrist, who will provide clinical confirmation of each family’s eligibility for participation
  
• Have one non-autistic child aged between 5-14 years old
  
• All family members must have stable medical and behavioural conditions e.g. treated asthma, diabetes etc.
  
• Your family must be located in the Republic of Ireland
  
• All family members must be biologically related

Even if you meet the above criteria your family cannot take part in the study if:

• Any family member does not consent or assent to participate in the study

• Children are unable to tolerate sensors (if needed, a trial period can be undertaken to allow children to become familiar with wearing the sensors) \(^{2}\)

• Any family member has a DSM-5 diagnosis of an intellectual disability
  

• Autistic children do not have a clinical report confirming their diagnosis
  

• Individuals have conditions associated with secondary autism (e.g., Rett syndrome)
  

• Children have a complex neurologic disorder (cerebral palsy, phenylketonuria, tuberous sclerosis, neurofibromatosis, unstable seizure disorder [a seizure within 6 months])
  

• Children have known genetic syndromes with characteristic behavioural phenotypes, e.g., Fragile X, DiGeorge Syndrome, Smith Magenis Syndrome
  

• Children have co-morbid psychiatric conditions including schizophrenia and psychosis, whereas other common conditions such as ADHD and Anxiety are not exclusionary. Other examples of cooccurring neurodevelopmental or emotional features can be emotional regulation difficulties (i.e. difficulties managing emotional responses) and mild emotional or mood related symptoms (i.e. subthreshold depressive symptoms) that do not meet criteria for a formal psychiatric diagnosis.

• Children have an unstable/untreated medical condition (e.g., asthma, diabetes, cystic fibrosis etc) or any other condition/factor that would limit their ability to participate in the study (e.g., severe physical disability)
  

• Children have significant uncorrected hearing or vision loss
  

• Children have known sleeping conditions/disorders (e.g., untreated moderate-severe obstructive sleep apnoea, narcolespy, clinically significant restless leg syndrome) and other family members have unstable/untreated sleeping conditions/disorders
  

• Any family member is taking sleep altering drugs, including melatonin or stimulants

• Any family member has a known history of obstructive sleep apnoea, narcolepsy, or restless leg syndrome
  

• A member of the household has a major neuropsychiatric disorder

• You are a member of the FamilySleeps team
  

• Either parent is a shift worker
  

• Either parent drinks more alcohol per week than safe HSE recommendations (women 11 drinks, men 17 drinks)
  Some examples of a standard drink are:

  A pub measure of spirits (35.5ml)

  A small glass of wine (12.5% volume)

  A half pint of normal beer

  An alcopop (275ml bottle)

  A bottle of 12.5% alcohol wine has about 7 standard drinks.

• Either adult uses recreational drugs
  

• Either adult is a smoker or vapes

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\(^{2}\) A brief, optional familiarisation period will be offered prior to enrolment to establish the child’s sensitivity to the wristworn sensors. Parents will be provided with nonrecording, inert devices (available in two colour options) for the child to wear at home for a period of two to three days. During this period, parents are asked to observe and report the child’s comfort, willingness to wear the device and any signs of distress or refusal. No study data are collected during this phase. For decision making the following go/nogo criteria will be observed:

– Go: The child is willing to wear the device for typical daily periods without distress, and both the child and parent report acceptable comfort and tolerability.

– Nogo: The child expresses ongoing unwillingness, removes the device repeatedly, or shows distress despite the familiarisation period. In such cases, the child will not proceed to enrolment. Only where tolerability is established will the standard assent and consent procedures be undertaken, in line with the approved study protocol.