Autism Spectrum Disorder Mental and Behavioural Disorders Autism Spectrum Disorder
Conditions
Interventions
Current interventions as of 18/05/2018:
Parents are contacted about the project and to see if their child is eligible for the project. This involves asking questions about their child’s autism symptom
Sponsors
The Royal Children’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 18/02/2019: 1. Families of children aged 5-12 years (all genders) (13 years if attending primary school). 2. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM-5). A SCQ cut off score of >= 11 will be used. 3. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013): chronic insomnia (including problems of initiating and maintaining sleep, sleep-onset association, limit-setting, and anxiety-related insomnia) or delayed sleep-wake phase. Previous inclusion criteria as of 18/10/2017: 1. Families of children aged 5-12 years (all genders) (13 years if attending primary school) 2. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM-5). A SCQ cut off score of >= 11 will be used 3. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013): chronic insomnia (including problems of initiating and maintaining sleep, sleep-onset association, limit-setting, and anxiety-related insomnia), delayed sleep-wake phase or parasomnias (including nightmares, sleep terrors and sleepwalking) Previous inclusion criteria: 1. Families of children aged 5-12 years (all genders) 2. ASD symptoms meeting criteria for ASD according to the Social Communication Questionnaire. The child must have previously received a conclusive multi-disciplinary diagnosis of Autistic Disorder or Asperger's Disorder (according to Diagnostic and Statistical manual of Mental Disorders, 4th Edition; DSM-IV), or ASD (according to Diagnostic and Statistical manual of Mental Disorders, 5th Edition; DSM-5). 3. Moderate to severe sleep problems, with at least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2013): chronic insomnia (including problems of initiating and maintaining sleep, sleep-onset association, limit-setting, and anxiety-related insomnia), delayed sleep-wake phase or parasomnias (including nightmares, sleep terrors and sleepwalking)
Exclusion criteria
Exclusion criteria: Current exclusion criteria: 1. Intellectual disability 2. Have comorbid medical condition that affects sleep (e.g. nocturnal seizures, blindness), or syndromic genetic (e.g. Fragile X) conditions 3. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician 4. Non-English speaking Previous exclusion criteria: 1. Intellectual disability 2. Have comorbid medical (e.g. epilepsy), neuropsychiatric (e.g. Tourette's) or syndromic genetic (e.g. Fragile X) conditions 3. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with a paediatrician 4. Non-English speaking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/02/2019: Parent reports of child sleep problem are measured by the Children’s Sleep Habits Questionnaire at baseline and 3 months post randomisation (post intervention). Previous primary outcome measure as of 18/05/2018: Parent reports of child sleep problem are measured by the Child Sleep Habits Questionnaire at baseline, 3, and 6 months. Previous primary outcome measure: Parent reports of child sleep problem are measured by the Child Sleep Habits Questionnaire at baseline, 3, 6, and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/02/2019: Child secondary outcome measures: 1. Child sleep problems measured by Children’s Sleep Habits Questionnaire (parent report measured at baseline and 6 months post randomisation), parent report of sleep problem severity and sleep hygiene (parent report at baseline, 3 and 6 months post randomisation), and Teacher Daytime Sleepiness Questionnaire (teacher report at baseline, 3 and 6 months post randomisation). 2. Emotional and behavioural problems as measured by Strength and Difficulties Questionnaire (parent and teacher reports at baseline, 3 and 6 months post randomisation) and Developmental Behaviour Checklist (parent report at baseline and 6 months) 3. Social-communicative symptoms as measured by Social Communication Questionnaire current form (parent reports at baseline, 3 and 6 months post randomisation) 4. Cognitive and academic performances as measured by the NIH cognitive toolbox and selected measures from the Wide Range Achievement Test 4th Edition (blinded, direct assessments at 6 months post randomisation), linkage to NAPLAN results (standardised national assessment of literacy and numeracy Australian children complete in Grades 3, 5, 7 and 9) and school attendance 5. Quality of life as measured by Child Health Utilities 9D (parent reports at baseline, 3 and 6 months post randomisation). Parent secondary outcome measures: 1. Parent mental health symptoms are measured using K10 (Kessler 10) at baseline, 3 and 6 months post randomisation. 2. Parent stress is measured using the PSI-4-SF (Parenting stress index, fourth edition, short form) at baseline, 3 and 6 months post randomisation. 3. Parent quality of life measured using the AQoL4D (Adult Quality of Life Questionnaire 4D) at baseline, 3 and 6 months post randomisation and parent-reported work attendance Economic outcome measure: Cost-effectiveness of the intervention is measured using a cost-utility and cost-consequence analysis between the two arms o | — |
Countries
Australia
Contacts
Public ContactSusannah Bellows
Outcome results
None listed