A randomised controlled trial to determine whether mental health problems and significant psychological distress in children involved in everyday road traffic accidents can be prevented
| ISRCTN | ISRCTN34861010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34861010 |
| Secondary identifying numbers | C/INJ/12/05.99/Stallard |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 12/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul Stallard
Scientific
Scientific
Avon & Western Wiltshire Mental Health Care NHS Trust
Department of Child and Family Psychiatry
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
| Phone | +44 (0)1225 825075 |
|---|---|
| paul.stallard@awp.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Post-traumatic stress disorder (PTSD); depression; anxiety |
| Intervention | 1. Trauma discussion (intervention) 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/01/2000 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 276 |
| Key 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. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Avon & Western Wiltshire Mental Health Care NHS Trust
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South West (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No |
