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Clinical Trials/ACTRN12620001276943
ACTRN12620001276943
Completed
N/A

Telehealth Sleeping Sound ASD: A pilot feasibility and acceptability randomized control trial of a brief behavioural sleep intervention program for autistic children aged 5-12 years.

Monash University0 sites61 target enrollmentNovember 26, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Monash University
Enrollment
61
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 26, 2020
End Date
October 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Eligibility requirements for child:
  • Multidisciplinary 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 5\-12 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) or delayed sleep phase disorder AND
  • Child has not been diagnosed with an intellectual disability on parent report
  • Living in Australia
  • 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

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.

Outcomes

Primary Outcomes

Not specified

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