Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/02/2014
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

Dr Lucinda Wiggs

ORCID ID

Contact details

Department of Psychiatry
University section
Park Hospital
Old Road
Headington
Oxford
OX3 7LQ
United Kingdom
+44 (0)1865 226516

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0584127466

Study information

Scientific title

Acronym

Study hypothesis

Is behavioural treatment for sleep problems effective in treating sleeplessness in children with autism? If so, are there any associated effects on the children's behaviour and the parents' well being?

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

Intervention

Patients are randomised to behavioural treatment or care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Children's sleep patterns (assessed by diary, interview and activity monitors)
2. Child behaviour (parent and teacher questionnaire report)
3. Parental well being (self report questionnaire)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Formal diagnosis of autism according to internationally accepted International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD 10) criteria as applied by local specialised childhood autism service
2. Aged between 5 and 11 years old
3. Have severe bedtime settling and/or troublesome night waking problems of at least 12 months duration

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychiatry, University section
Oxford
OX3 7LQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Charity

Funder name

The Shirley Foundation (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

Publication citations

Additional files

Editorial Notes