Contact information
Type
Scientific
Primary contact
Mr Paul Stallard
ORCID ID
Contact details
Avon & Western Wiltshire Mental Health Care NHS Trust
Department of Child and Family Psychiatry
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
+44 (0)1225 825075
paul.stallard@awp.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C/INJ/12/05.99/Stallard
Study information
Scientific title
Acronym
Study hypothesis
A significant number of children develop mental health problems (PTSD, depression, anxiety) and suffer major psychological changes (mood, relationships, behaviour, social life, school attendance) as a result of road traffic accidents. This study aims to evaluate whether a brief intervention designed to encourage discussion about the accident is effective in preventing mental health problems whilst facilitating post-accident psychological functioning.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Post-traumatic stress disorder (PTSD); depression; anxiety
Intervention
1. Trauma discussion (intervention)
2. Standard care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Pre and post measures will allow between & within group comparisons in order to determine whether the intervention was effective in preventing the development of mental health problems and facilitating post-accident psychological functioning. Standard psychometric questionnaires and semi-structured interview will be used.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2000
Overall trial end date
31/12/2003
Reason abandoned
Eligibility
Participant inclusion criteria
A total of 276 children aged 7-18 attending a hospital A&E Department following involvement in a road traffic accident will be recruited.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
276
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2000
Recruitment end date
31/12/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Avon & Western Wiltshire Mental Health Care NHS Trust
Bath
BA1 3NG
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South West (UK)
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16423143
Publication citations
-
Results
Stallard P, Velleman R, Salter E, Howse I, Yule W, Taylor G, A randomised controlled trial to determine the effectiveness of an early psychological intervention with children involved in road traffic accidents., J Child Psychol Psychiatry, 2006, 47, 2, 127-134, doi: 10.1111/j.1469-7610.2005.01459.x.