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
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

Department of Psychiatry
University Section
Park Hospital
Old Road
Headington
Oxford
OX3 7LQ
United Kingdom

Phone +44 (0)1865 226515

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesWhat 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) studiedSleep disorders; learning disability
Intervention3 groups
1. Conventional behavioural techniques
2. Written information
3. Control group (no info or support)
Each for 6 weeks duration
Intervention typeOther
Primary outcome measure1. Sleep diary
2. Activity monitors
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/1998
Completion date01/02/2000

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Years
Upper age limit5 Years
SexBoth
Target number of participants66 (added 25/01/10; see publication)
Key inclusion criteria1. 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 criteriaSleep problems thought to be due to physical discomfort
Date of first enrolment01/08/1998
Date of final enrolment01/02/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Psychiatry
Oxford
OX3 7LQ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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