Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
12/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes