Helping children's centres to enhance home safety
| ISRCTN | ISRCTN65067450 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65067450 |
| ClinicalTrials.gov number | NCT01452191 |
| Secondary identifying numbers | 10583 |
- Submission date
- 06/12/2012
- Registration date
- 06/12/2012
- Last edited
- 06/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Denise Kendrick
Scientific
Scientific
University of Nottingham
Division of Primary Care
14th Floor
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom
 ORCID ID |
0000-0003-3603-6542 |
|---|---|
| denise.kendrick@nottingham.ac.uk |
Study information
| Study design | Randomised interventional prevention process of care study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Current ethics approval as of 06/02/2019: Derbyshire Research Ethics Committee, 18/03/2011, ref. 11/EM/0011. University of the West of England, Bristol, Research Ethics Committee, 22/07/2011, ref. HSC/11/06/61. Previous ethics approval: First MREC, 18/03/2011, ref: 11/EM/0011 |
| Health condition(s) or problem(s) studied | 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): Facilitation 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 |
| Primary outcome measure | 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 study start date | 01/06/2011 |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1080; UK Sample Size: 1080; Description: 36 Children’s Centres 30 parents from each Children’s centre = 1080 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/06/2011 |
| Date of final enrolment | 31/03/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
NIHR Programme Grants for Applied Research (UK) ref: RP-PG-0407-10231
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/01/2014 | Yes | No | |
| Results article | qualitative study results | 10/12/2014 | Yes | No | |
| Other publications | recruitment and retention strategies | 07/03/2015 | Yes | No | |
| Results article | results | 15/12/2015 | Yes | No | |
| Results article | results | 24/03/2017 | Yes | No | |
| Results article | results | 01/07/2017 | Yes | No |
Editorial Notes
06/02/2019: The following changes were made:
1. The primary contact was updated.
2. The ethics approval was updated.
3. Publication references added.
31/05/2016: Publication reference added.
