Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPGS756
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. Sleep diary
2. Activity monitors
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/1998
Overall trial end date
01/02/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
66 (added 25/01/10; see publication)
Participant exclusion criteria
Sleep problems thought to be due to physical discomfort
Recruitment start date
01/08/1998
Recruitment end date
01/02/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychiatry
Oxford
OX3 7LQ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14736626
Publication citations
-
Results
Montgomery P, Stores G, Wiggs L, The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial., Arch. Dis. Child., 2004, 89, 2, 125-130.