An evaluation of the Sleeping Sound program on children's sleep difficulties in children with Autism Spectrum Disorder and Intellectual Disability.

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Intellectual Disability; Sleep problems; Mental Health - Autistic spectrum disorders; Mental Health - Learning disabilities

• Registration Number: ACTRN12618000619246
• Lead Sponsor: Dr Nicole Papadopoulos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Study Completion: 2020-02-12
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parent reports of child sleep problems (measured by the Children's Sleep Habits Questionnaire) [To be measured at baseline and at three and six months post randomisation.];A series of custom questions that have been designed specially to evaluate perceptions of the Sleeping Sound program will be used to measure parents thoughts of the sleep program.[This will be measured at three months post randomisation for the parents who are allocated to the intervention group.]