A randomised controlled trial of sleep problems for children with autism
| ISRCTN | ISRCTN74087708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74087708 |
| Secondary identifying numbers | N0584127466 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lucinda Wiggs
Scientific
Scientific
Department of Psychiatry, University section
Park Hospital
Old Road
Headington
Oxford
OX3 7LQ
United Kingdom
| Phone | +44 (0)1865 226516 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sleep disorders |
| Intervention | Patients are randomised to behavioural treatment or care as usual. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychiatry, University section
Oxford
OX3 7LQ
United Kingdom
OX3 7LQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Charity
The Shirley Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
