Development of effective primary care treatment of severe sleep disorders in children with a learning disability; a randomised controlled trial
ISRCTN | ISRCTN84194243 |
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DOI | https://doi.org/10.1186/ISRCTN84194243 |
Secondary identifying numbers | SPGS756 |
- 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 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
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 | 1. Sleep diary 2. Activity monitors |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/08/1998 |
Completion date | 01/02/2000 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 2 Years |
Upper age limit | 5 Years |
Sex | Both |
Target number of participants | 66 (added 25/01/10; see publication) |
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
- England
- United Kingdom
Study participating centre
Department of Psychiatry
Oxford
OX3 7LQ
United Kingdom
OX3 7LQ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/02/2004 | Yes | No |