A randomised controlled trial of sleep problems for children with autism
| ISRCTN | ISRCTN74087708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74087708 |
| Protocol serial number | N0584127466 |
| Sponsor | Department of Health |
| Funder | The Shirley Foundation (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Children's sleep patterns (assessed by diary, interview and activity monitors) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 11 Years |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Department of Psychiatry, University section
Oxford
OX3 7LQ
United Kingdom
OX3 7LQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
