ISRCTN ISRCTN47132534
DOI https://doi.org/10.1186/ISRCTN47132534
Protocol serial number MCH 14-11
Sponsor Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder NHS Mother and Child Health National Research and Development Programme (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
22/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Moore
Scientific

Greenwood Institute of Child Health
University of Leicester
Westcotes Drive
Leicester
LE3 0JU
United Kingdom

Phone +44 (0)116 225 2880
Email johnmoore11@doctors.org.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and behavioural disorders: Behavioural disorders
InterventionThe 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/1999

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Target sample size at registration99
Key inclusion criteriaThe 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.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1996
Date of final enrolment31/12/1999

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Greenwood Institute of Child Health
Leicester
LE3 0JU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 28/06/2008 Yes No