BurnsNCT01452191
Helping Children's Centres to Enhance Home Safety
A study testing Injury Prevention Briefing Plus facilitation and Injury Prevention Briefing in people with Burns and Smoke Inhalation Injury, run by University of Nottingham at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burns, Smoke Inhalation Injury
- What is being tested?
- Injury Prevention Briefing Plus facilitation and Injury Prevention Briefing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,112 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Aug 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University of West of England, Bristol
Bristol, BS8 2BN
Newcastle University
Newcastle, NE2 4HH
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY
University of Nottingham
Nottingham, NG7 2RD
About this study
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
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.
Read more
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.
- Conditions
- Burns, Smoke Inhalation Injury
- Being tested
- Injury Prevention Briefing Plus facilitation, Injury Prevention Briefing
- Keywords
- Cluster Randomised Controlled Trial, Community Health Services, prevention & control, Accidents, Home, Child Health Services
- Medical subject headings
- Burns, Smoke Inhalation Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injury Prevention Briefing Plus facilitationBehavioural
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 BriefingBehavioural
Children's centres will receive the Injury Prevention Briefing only.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Injury Prevention Briefing |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).
Measured: 1 year
Secondary outcomes (5)
The Number of Childrens Centres Providing Information and Advice on Smoke Alarms
Measured: 1 year
The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan
Measured: 1 year
The Number of Children's Centres Providing Information and Advice on the Causes of House Fires
Measured: 1 year
The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention
Measured: 1 year
The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Kendrick, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452191
- Sponsor's protocol ID
- 11007
- Status last verified
- May 2019
- First submitted
- 10 Oct 2011
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26670153Hindmarch 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.
PubMed 25886131Deave 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.
PubMed 24450931
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01452191
- Acronym / sponsor ID
- 11007
- Conditions
- Burns, Smoke Inhalation Injury
- Keywords
- Cluster Randomised Controlled Trial, Community Health Services, prevention & control, Accidents, Home, Child Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,112 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injury Prevention Briefing and facilitation | Active comparator | Behavioral: Injury Prevention Briefing Plus facilitationChildren'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 |
| Injury Prevention Briefing only | Active comparator | Behavioral: Injury Prevention BriefingChildren's Centres will be given an Injury Prevention Briefing (IPB) , which offers guidance on best evidence on reducing fire related injuries in the home. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injury Prevention Briefing Plus facilitationInjury 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 | Behavioural | Injury Prevention Briefing and facilitation |
| Injury Prevention BriefingChildren's centres will receive the Injury Prevention Briefing only. | Behavioural | Injury Prevention Briefing only |
Primary outcome
Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).
Time frame: 1 year
5 secondary outcomes
The Number of Childrens Centres Providing Information and Advice on Smoke Alarms
Time frame: 1 year
The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan
Time frame: 1 year
The Number of Children's Centres Providing Information and Advice on the Causes of House Fires
Time frame: 1 year
The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention
Time frame: 1 year
The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26670153Ploubidis 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.
- Derived from this study: PubMed 25886131Hindmarch 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.
- Derived from this study: PubMed 24450931Deave 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Kendrick principal investigator
University of Nottingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injury Prevention Briefing Plus facilitation and Injury Prevention Briefing in people with Burns and Smoke Inhalation Injury, run by University of Nottingham at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01452191, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.