Clinical trial NCT01452191: Helping Children's Centres to Enhance Home Safety
Official 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 Fire-related Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Smoke Inhalation Injury
Keywords: Cluster Randomised Controlled Trial
Community Health Services
prevention & control
Accidents, Home
Child Health Services
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 1112
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).
timeFrame: 1 year
Secondary outcomes:
measure: The Number of Childrens Centres Providing Information and Advice on Smoke Alarms
timeFrame: 1 year
measure: The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan
timeFrame: 1 year
measure: The Number of Children's Centres Providing Information and Advice on the Causes of House Fires
timeFrame: 1 year
measure: The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention
timeFrame: 1 year
measure: The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires
timeFrame: 1 year
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University of West of England, Bristol
city: Newcastle
country: United Kingdom
facility: Newcastle University
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Denise Kendrick
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.