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21 March 2013
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| [ Print-friendly version ] |
| Helping children's centres to enhance home safety |
| ISRCTN | ISRCTN65067450 |
| DOI | 10.1186/ISRCTN65067450 |
| ClinicalTrials.gov identifier | NCT01452191 |
| EudraCT number | |
| Public title | Helping children's centres to enhance home safety |
| 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 | N/A |
| Serial number at source | 10583 |
| 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." More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10583 |
| Lay summary | Not provided at time of registration |
| Ethics approval | First MREC, 18 March 2011, ref: 11/EM/0011 |
| Study design | Randomised interventional prevention process of care study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Primary Care Research Network for England |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/06/2011 |
| Anticipated end date | 11/05/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Interventions |
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 |
| Primary outcome measure(s) | The proportion of families who have a fire escape plan (ascertained from self-completion questionnaire measured at 12 months |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | NIHR Programme Grants for Applied Research (UK) ref: RP-PG-0407-10231 |
| Trial website | http://www.nottingham.ac.uk/injuryresearch/projects/kcs/index.aspx |
| Publications | |
| Contact name | Mrs Jane Stewart |
| Address |
University of Nottingham
Division of Primary Care 14th Floor Tower Building University Park |
| City/town | Nottingham |
| Zip/Postcode | NG7 2RD |
| Country | United Kingdom |
| Jane.Stewart@nottingham.ac.uk | |
| Sponsor | University of Nottingham (UK) |
| Address |
Research Innovation Services
Kings Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 06/12/2012 |
| Last edited | 06/12/2012 |
| Date ISRCTN assigned | 06/12/2012 |
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