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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01452191
Other study ID # 11007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2011
Est. completion date September 2013

Study information

Verified date May 2019
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1112
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Injury Prevention Briefing Plus facilitation
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
Injury Prevention Briefing
Children's centres will receive the Injury Prevention Briefing only.

Locations

Country Name City State
United Kingdom University of West of England, Bristol Bristol
United Kingdom Newcastle University Newcastle
United Kingdom Norfolk and Norwich University Hospitals NHS Foundation Trust Norwich
United Kingdom University of Nottingham Nottingham

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire). 1 year
Secondary The Number of Childrens Centres Providing Information and Advice on Smoke Alarms 1 year
Secondary The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan 1 year
Secondary The Number of Children's Centres Providing Information and Advice on the Causes of House Fires 1 year
Secondary The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention 1 year
Secondary The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires 1 year
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