- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01452191
Helping Children's Centres to Enhance Home Safety
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 Fire-related Injuries
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 and 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.
The study will run from May 2011 to March 2014.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bristol, United Kingdom, BS8 2BN
- University of West of England, Bristol
-
Newcastle, United Kingdom, NE2 4HH
- Newcastle University
-
Norwich, United Kingdom, NR4 7UY
- Norfolk and Norwich University Hospitals NHS Foundation Trust
-
Nottingham, United Kingdom, NG7 2RD
- University of Nottingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
There are two levels of participation, Children's Centres as participants, who will be delivering the intervention, and 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.
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 Families who attend a participating Children's Centre who do not have any children under the age of 3 years Any parent who is under-16 years of age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Active Comparator: Injury Prevention Briefing and facilitation
Children's Centres will be given an Injury Prevention Briefing which offers guidance on best evidence on reducing fire related injuries in the home, and facilitation by the research team to support implementation of the IPB
|
Injury Prevention Briefing (IPB) to provide best evidence on what works to reduce house fire injuries, and activities to get the evidence into practice.
This arm will receive facilitation to support the implementation of the information in the IPB
|
Active Comparator: Injury Prevention Briefing only
Children's Centres will be given an Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home.
|
Children's centres will receive the Injury Prevention Briefing only.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Number of Childrens Centres Providing Information and Advice on Smoke Alarms
Time Frame: 1 year
|
1 year
|
The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan
Time Frame: 1 year
|
1 year
|
The Number of Children's Centres Providing Information and Advice on the Causes of House Fires
Time Frame: 1 year
|
1 year
|
The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention
Time Frame: 1 year
|
1 year
|
The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Denise Kendrick, University of Nottingham
Publications and helpful links
General Publications
- Ploubidis GB, Edwards P, Kendrick D; Keeping Children Safe Study Group. Measuring behaviours for escaping from house fires: use of latent variable models to summarise multiple behaviours. BMC Res Notes. 2015 Dec 15;8:789. doi: 10.1186/s13104-015-1769-5.
- Hindmarch P, Hawkins A, McColl E, Hayes M, Majsak-Newman G, Ablewhite J, Deave T, Kendrick D; Keeping Children Safe study group. Recruitment and retention strategies and the examination of attrition bias in a randomised controlled trial in children's centres serving families in disadvantaged areas of England. Trials. 2015 Mar 7;16:79. doi: 10.1186/s13063-015-0578-4.
- Deave T, Towner E, McColl E, Reading R, Sutton A, Coupland C, Cooper N, Stewart J, Hayes M, Pitchforth E, Watson M, Kendrick D. Multicentre cluster randomised controlled trial evaluating implementation of a fire prevention Injury Prevention Briefing in children's centres: study protocol. BMC Public Health. 2014 Jan 22;14:69. doi: 10.1186/1471-2458-14-69.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11007 (DAIDS ES Registry Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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