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ISRCTN
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ISRCTN74087708
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of sleep problems for children with autism
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0584127466
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Study hypothesis
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Is behavioural treatment for sleep problems effective in treating sleeplessness in children with autism? If so, are there any associated effects on the children's behaviour and the parents' well being?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Sleep disorders
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Participants - inclusion criteria
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1. Formal diagnosis of autism according to internationally accepted International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD 10) criteria as applied by local specialised childhood autism service
2. Aged between 5 and 11 years old
3. Have severe bedtime settling and/or troublesome night waking problems of at least 12 months duration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2001
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Anticipated end date
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31/08/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Patients are randomised to behavioural treatment or care as usual.
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Primary outcome measure(s)
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1. Children's sleep patterns (assessed by diary, interview and activity monitors)
2. Child behaviour (parent and teacher questionnaire report)
3. Parental well being (self report questionnaire)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Shirley Foundation (UK)
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Trial website
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Publications
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Contact name
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Dr
Lucinda
Wiggs
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Address
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Department of Psychiatry, University section
Park Hospital
Old Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LQ
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Country
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United Kingdom
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Tel
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+44 (0)1865 226516
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Fax
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+44 (0)1865 762358
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Email
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lucinda.wiggs@psychiatry.oxford.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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12/05/2008
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Date ISRCTN assigned
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30/09/2004
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