Condition category
Not Applicable
Date applied
06/12/2012
Date assigned
06/12/2012
Last edited
31/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Mrs Jane Stewart

ORCID ID

Contact details

University of Nottingham
Division of Primary Care
14th Floor
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom
-
Jane.Stewart@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

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):
Faciliation 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 measures

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

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 Centre’s 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

http://www.nottingham.ac.uk/

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25778578
2015 recruitment and retention strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25886131

Publication citations

Additional files

Editorial Notes

31/05/2016: Publication reference added.