Plain English Summary
Not provided at time of registration
Trial website
http://www.nottingham.ac.uk/injuryresearch/projects/kcs/index.aspx
Contact information
Type
Scientific
Primary contact
Prof Denise Kendrick
ORCID ID
http://orcid.org/0000-0003-3603-6542
Contact details
University of Nottingham
Division of Primary Care
14th Floor
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom
-
denise.kendrick@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01452191
Protocol/serial number
10583
Study information
Scientific title
Keeping children safe at home: cluster randomised controlled trial of the implementation of an injury prevention briefing in children's centres for the prevention of specific types of injuries
Acronym
Study hypothesis
Many children have accidents, some are very serious and they are a major cause of death in children aged 1-4 years. Many accidents are preventable This study aims to find out the best way to help Children’s Centres to provide home safety information about preventing fires to parents and carers of young children.
36 Children’s Centres in four study centres (Nottingham, Bristol, Norwich, Newcastle) will be recruited to the study. 30 families will be recruited from each Children’s Centre. Children's Centres serving the most deprived populations will be eligible to take part . Families will be eligible to take part if they have attended a participating Children’s Centre in the previous three months, have parents who are 16 years or older, have a child under three years old and live within the catchment area of that Children’s Centre. When 30 families have been recruited that Centre will be allocated, at random, to one of three groups. Children's Centres in group one will be provided with guidance about preventing fire-related injuries (an Injury Prevention Briefing (IPB))and help and support to implement the IPB, the second group will be sent the IPB and the third group will not be provided with the IPB (“usual care”). Children's Centres will devise their own programmes of safety advice for parents based on the IPB.
At recruitment and 12 months later, families and Children's Centres will complete questionnaires about fire safety practices. Children’s Centres will also complete a paper-based tool about the implementation process at 12 months. Information about barriers and facilitators to implementing the IPB will be collected through interviews with Children’s Centre staff.
Ethics approval
Current ethics approval as of 06/02/2019:
Derbyshire Research Ethics Committee, 18/03/2011, ref. 11/EM/0011.
University of the West of England, Bristol, Research Ethics Committee, 22/07/2011, ref. HSC/11/06/61.
Previous ethics approval:
First MREC, 18/03/2011, ref: 11/EM/0011
Study design
Randomised interventional prevention process of care study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary Care Research Network for England
Intervention
Injury Prevention Briefing
This arm will be sent the IPB to use, but will not receive facilitation to implement it.
Injury Prevention Briefing + Children's Centres allocated to the Injury Prevention Briefing (IPB):
Facilitation will be provided with an IPB (developed by the study team) that documents evidence based interventions known to reduce injuries, and strategies to get these into practice. The research team will facilitate the use of the IPB in this group.
Usual care group:
Will receive usual care delivered by Children's Centres.
Follow Up Length: 12 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The proportion of families who have a fire escape plan (ascertained from self-completion questionnaire measured at 12 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2011
Overall trial end date
31/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
There are two levels of participation:
1. Children's Centres as participants, who will be delivering the intervention
2. Families as participants, who will be receiving the intervention
Children’s Centres:
Phase 1 Children’s Centres in the four study areas (Nottingham, Newcastle, Bristol and Norwich)
Phase 2 Children’s Centres in more disadvantaged areas (defined as those who have more than 50% of under 5 year-old children in their Centre catchment area who live in one of the 30% most disadvantaged Super Output Areas).
Families:
Any family who has attended the participating Children’s Centre in the previous three months, who have a child under three years old, and lives within the catchment area of that Children’s Centres.
Male or female participants, aged over 16 years.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 1080; UK Sample Size: 1080; Description: 36 Children’s Centres 30 parents from each Children’s centre = 1080
Participant exclusion criteria
Children’s Centres:
Phase 2 Children’s Centres that are not in more disadvantaged areas as defined above and phase 3 or subsequent wave Children’s Centres.
Families
1. Families who attend a participating Children’s Centre who do not have any children under the age of 3 years
2. Any parent who is under-16 years of age
Recruitment start date
01/06/2011
Recruitment end date
31/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Programme Grants for Applied Research (UK) ref: RP-PG-0407-10231
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
1. 2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/24450931
2. 2014 qualitative study results in: https://www.ncbi.nlm.nih.gov/pubmed/25492496
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25778578
4. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26670153
5. 2015 recruitment and retention strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25886131
6. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28771290
7. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28339460