Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/07/2011
Date assigned
28/07/2011
Last edited
24/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Accidental injury is one of the main causes of death in preschool age children in the UK. Most of these injuries occur in the home, and many of these are easily preventable. In the UK between the year 2000 and 2002, about 502,000 children under four years old had to visit the hospital after an injury in the home. Studies have shown that parenting programmes, which educate parents, supporting them to change their behaviour can help to reduce the amount of injuries their children sustain. Many parents have shown an interest in learning first aid so that they are better able to take care of their children, should they become injured. From this, a parenting programme called FAST (First Aid and Safety Training) has been designed which incorporates first aid skills with learning safety advice to help prevent avoidable injuries in the home. The aim of this study is to find out how successful putting such a programme in place would be.

Who can participate?
Parents or guardians of a child under 5 years of age who has received an injury at home that required treatment in hospital in the last year.

What does the study involve?
Each of the children’s centres participating in the study are randomly allocated into two groups. Parent participants from centres in the first group (intervention group) complete the FAST parenting programme at the children’s centres. Parent participants in the second group (control group) are not given the parenting programme. Parents in both groups are asked to complete “injury calendars” documenting any injuries their children have received in the home over the next six months.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
Eight children’s centres in Bristol and Nottingham (UK)

When is the study starting and how long is it expected to run for?
July 2011 to September 2011

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Sarah Manns

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Manns

ORCID ID

Contact details

Centre for Child & Adolescent Health
Oakfield House
15-23 Oakfield Grove
Bristol
BS8 2BN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10111

Study information

Scientific title

The First-aid Advice and Safety Training (FAST) parent programme for the prevention of recurrent home injuries in preschool children

Acronym

FAST

Study hypothesis

The study is a cluster randomised complex intervention to prevent recurrent home injuries in preschool children using a parenting programme that provides safety training and first aid advice

Ethics approval

South West – Central Bristol NRES, 27 January 2011, ref: 10/H0106/78

Study design

Randomised, interventional, preventative trial

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

Injuries and Emergencies

Intervention

Parenting programme - Intervention sites will offer a parenting programme providing first aid advice and safety training

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Injuries occurring to index child during six month follow up period

Secondary outcome measures

The following outcome measures are collected at baseline and at the end of a 6 months (period of observed time):
1. Parent reported injuries to the study child that did not require medical attention
2. Parent reported injuries to the preschool siblings of the study child that did not require medical attention
3. Child behaviour (using the Child Behaviour Checklist or the Strengths and Difficulties questionnaire depending on the age of the child)
4. First aid knowledge (using the Nottingham Safe at Home Project Questionnaire)
5. Parent reported safety practices and possession and use of safety equipment (using the Nottingham home safety equipment measure)
6. Maternal wellbeing (using the Warwick Edinburgh Mental Well-being Scale)
7. Parenting (using the Parent Supervision Attributes Profile Questionnaire)

Overall trial start date

01/07/2011

Overall trial end date

01/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. The parents/carers will be eligible if they have a child under 5 years of age who has sustained an unintentional physical injury or ingestion in the home (or within the boundary of the home and garden/yard), that resulted in seeking medical attention from a health professional at an NHS Walk-In Centre, Minor Injuries Unit or in an Accident and Emergency department in secondary care during the recruitment period.
2. Parents/carers must be living at an address within the geographical or general practice catchment area of a Children’s Centre participating in the study
3. Male or female participants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 64

Participant exclusion criteria

1. Children suffering suspected or confirmed intentional injuries will be excluded
2. Should an injury originally considered to be unintentional be later discovered to have been intentional, then routine referral processes for safeguarding would be activated
3. That parent would not be asked to withdraw from the programme, but data from that child will not be included in the analysis
4. Parents/carers who are unable to understand written and spoken English will be excluded from the feasibility study

Recruitment start date

01/07/2011

Recruitment end date

01/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Child & Adolescent Health
Bristol
BS8 2BN
United Kingdom

Sponsor information

Organisation

University of the West of England (UK)

Sponsor details

School of Health & Social Care
Frenchay Campus
Coldharbour Lane
Bristol
BS16 1QY
United Kingdom

Sponsor type

University/education

Website

http://www.uwe.ac.uk/

Funders

Funder type

Government

Funder name

NIHR HTA; Grant Codes: 09/02/02

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24433822

Publication citations

  1. Results

    Mytton J, Ingram J, Manns S, Stevens T, Mulvaney C, Blair P, Powell J, Potter B, Towner E, Emond A, Deave T, Thomas J, Kendrick D, Stewart-Brown S, The feasibility of using a parenting programme for the prevention of unintentional home injuries in the under-fives: a cluster randomised controlled trial., Health Technol Assess, 2014, 18, 3, 1-184, doi: 10.3310/hta18030.

Additional files

Editorial Notes