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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.blackwell-synergy.com/links/doi/10.1046/j.1467-0658.2000.00091.x