NCT01452191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,112

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

May 1, 2019

Enrollment Period

2.1 years

First QC Date

October 10, 2011

Results QC Date

February 6, 2019

Last Update Submit

May 29, 2019

Conditions

Keywords

Cluster Randomised Controlled TrialCommunity Health Servicesprevention & controlAccidents, HomeChild Health Services

Outcome Measures

Primary Outcomes (1)

  • Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).

    1 year

Secondary Outcomes (5)

  • The Number of Childrens Centres Providing Information and Advice on Smoke Alarms

    1 year

  • The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan

    1 year

  • The Number of Children's Centres Providing Information and Advice on the Causes of House Fires

    1 year

  • The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention

    1 year

  • The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires

    1 year

Study Arms (3)

Injury Prevention Briefing and facilitation

ACTIVE COMPARATOR

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

Behavioral: Injury Prevention Briefing Plus facilitation

Injury Prevention Briefing only

ACTIVE COMPARATOR

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.

Behavioral: Injury Prevention Briefing

Usual Care

NO INTERVENTION

Interventions

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 and facilitation

Children's centres will receive the Injury Prevention Briefing only.

Injury Prevention Briefing only

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of West of England, Bristol

Bristol, BS8 2BN, United Kingdom

Location

Newcastle University

Newcastle, NE2 4HH, United Kingdom

Location

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

BurnsSmoke Inhalation Injury

Condition Hierarchy (Ancestors)

Wounds and InjuriesBurns, Inhalation

Results Point of Contact

Title
Professor Denise Kendrick
Organization
University of Nottingham

Study Officials

  • Denise Kendrick

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2011

First Posted

October 14, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 26, 2019

Results First Posted

July 26, 2019

Record last verified: 2019-05

Locations