| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN74087708 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0584127466 |
| Public title | A Randomised Controlled Trial of Sleep Problems for children with Autism. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nervous System Diseases: Sleep disorders |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 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. Aged between 5 and 11 years old who have severe bedtime settling and/or troublesome night waking problems of at least 12 months duration. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/09/2001 |
| Anticipated end date | 31/08/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Randomised Controlled Trial. |
| Primary outcome measure(s) | Children's sleep patterns (assessed by diary, interview and activity monitors); child behaviour (parent and teacher questionnaire report); parental well being (self report questionnaire). |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Shirley Foundation |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Lucinda Wiggs |
| Contact details | Department of Psychiatry, University section
Park Hospital
Old Road
Headington
Oxford
United Kingdom
OX3 7LQ |
| Contact telephone | +44 (0)1865226516 |
| Contact fax | +44 (0)1865762358 |
| Contact email | lucinda.wiggs@psychiatry.oxford.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN74087708 |
| Date last extracted from ISRCTN register | 17/04/2008 |
