Development of effective primary care treatment of severe sleep disorders in children with a learning disability; a randomised controlled trial
| ISRCTN | ISRCTN84194243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84194243 |
| Protocol serial number | SPGS756 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 29/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gregory Stores
Scientific
Scientific
Department of Psychiatry
University Section
Park Hospital
Old Road
Headington
Oxford
OX3 7LQ
United Kingdom
| Phone | +44 (0)1865 226515 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | What is the relative efficacy of briefer treatment for sleep problems in children with learning disabilities for use in the primary care setting? What are the effects of these briefer treatments on maternal mental health and child behaviour? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Sleep disorders; learning disability |
| Intervention | 3 groups 1. Conventional behavioural techniques 2. Written information 3. Control group (no info or support) Each for 6 weeks duration |
| Intervention type | Other |
| Primary outcome measure(s) | 1. Sleep diary 2. Activity monitors |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/02/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 5 Years |
| Sex | All |
| Target sample size at registration | 66 |
| Key inclusion criteria | 1. Children age 2-5 years 2. Male or female 3. Severe learning disability 4. Severe sleep disorder present >3 months with the following characteristics 4.1. Night waking >3x/week disturbing parents 4.2. Taking >1 hr to settle child >3x/week |
| Key exclusion criteria | Sleep problems thought to be due to physical discomfort |
| Date of first enrolment | 01/08/1998 |
| Date of final enrolment | 01/02/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Psychiatry
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2004 | Yes | No |
