Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gregory Stores

ORCID ID

Contact details

Department of Psychiatry
University Section
Park Hospital
Old Road
Headington
Oxford
OX3 7LQ
United Kingdom
+44 (0)1865 226515

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes