Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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 John Moore

ORCID ID

Contact details

Greenwood Institute of Child Health
University of Leicester
Westcotes Drive
Leicester
LE3 0JU
United Kingdom
+44 (0)116 225 2880
johnmoore11@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCH 14-11

Study information

Scientific title

Acronym

Study hypothesis

To test whether a child health record designed for pre-school children with a disability would:
1. Be used
2. Be valued by carers
3. Change the perception of the health care received by the child
4. Influence the amount of communication between the family and a professional who is seeing their child

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

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Mental and behavioural disorders: Behavioural disorders

Intervention

The intervention was a parent-held record for the parents of disabled children in which they could record contact details of the professionals seeing the child, the child's medical conditions and any medication and equipment used. A diary section allowed parents and professionals to record the child's progress and programme. There was also information about organisations relevant to children with disability. This was a quantitative individual controlled trial of AB design in which outcomes after six months without the intervention were compared those after a six-month intervention period. The participants were randomly allocated to three groups as follows:
Group 1: compared periods without and with the intervention
Group 2: measured any change without the intervention due to the passage of time
Group 3: estimated any effect due to the assessment after the first period without the intervention in Groups 1

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

At the end of the study, copies of the records were examined and the number of entries was taken as a measure of their value to the users. The parents also completed a questionnaire about the value of the record. The way families viewed their child's health care was tested by experimental control using a questionnaire before and after the intervention. At the same times, the amount of communication between the parents and professionals was assessed by both parties completing an identical questionnaire about the child; the similarity between their replies was taken to be a measure of communication.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant inclusion criteria

The participants were randomly selected pre-school children in the community who had been notified to the Education Department as likely to have special educational needs.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

99

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1996

Recruitment end date

31/12/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Greenwood Institute of Child Health
Leicester
LE3 0JU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Mother and Child Health National Research and Development Programme (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

Results in http://www.blackwell-synergy.com/links/doi/10.1046/j.1467-0658.2000.00091.x

Publication citations

Additional files

Editorial Notes