Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0584127466
Study information
Scientific title
Acronym
Study hypothesis
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Sleep disorders
Intervention
Patients are randomised to behavioural treatment or care as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2001
Overall trial end date
31/08/2004
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2001
Recruitment end date
31/08/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychiatry, University section
Oxford
OX3 7LQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Shirley Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary