Skip to main content
Clinical Trials/ACTRN12618000619246
ACTRN12618000619246
Completed
未知

A pilot randomised controlled trial of the Sleeping Sound Intervention on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.

Dr Nicole Papadopoulos0 sites11 target enrollmentApril 20, 2018

Overview

Phase
未知
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Dr Nicole Papadopoulos
Enrollment
11
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 20, 2018
End Date
February 12, 2020
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr Nicole Papadopoulos

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

Similar Trials