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 |
| Protocol serial number | C/INJ/12/05.99/Stallard |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Avon & Western Wiltshire Mental Health Care NHS Trust
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
