A pilot randomised trial to determine the efficacy of early cognitive behaviour therapy (CBT) versus delayed treatment for children with significant post-traumatic reactions.
| ISRCTN | ISRCTN05595708 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05595708 |
| Secondary identifying numbers | N0038183431 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 18/09/2017
- 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
Prof Stallard Paul
Scientific
Scientific
Department of Child & Family Therapy
RUH
Combe Park
Bath
BA1 3NG
United Kingdom
| Phone | +44 01225 825075 |
|---|---|
| paul.stallard@awp.nhs.uk |
Study information
| Study design | Pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A pilot randomised trial to determine the efficacy of early cognitive behaviour therapy (CBT) versus delayed treatment for children with significant post-traumatic reactions. |
| Study objectives | What is the efficacy of early, brief trauma-focused CBT for the treatment of significant acute posttraumatic reactions in child road traffic accident (RTA) victims? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Post-traumatic disorder |
| Intervention | 1. Immediate course of psychotherapeutic sessions 2. Delayed course of psychotherapeutic sessions Initial assessments for subjective distress, and diagnostic symptoms of PTSD. Children with high scores entered into study. Diary completed daily by child for 3 weeks, followed by assessments for PTSD, anxiety and depression. Those with significant enduring posttraumatic symptoms as determined by the CIES or the CPSS randomised into either the immediate or delayed treatment arms of the study. Change in the severity of posttraumatic symptoms, determined by MANOVA. Changes in associated anxiety and depression. CIES, CPSS. Treatment effect size for changes in PTST symptoms analysed using Cohen's D statistic. |
| Intervention type | Other |
| Primary outcome measure | 1. Child PTSD Symptom Scale (CPSS) 2. Children's Impact of Events Scale (CIES) 3. Children's Revised Manifest Anxiety Scale (MAS) 4. Birleson Depression Inventory (BDI) 5. 10 point cognitive change scale |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 27/04/2006 |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 20 |
| Key inclusion criteria | Children aged 7 to 18 who attend the A&E departments at the Royal United Hospital Bath, and Frenchay Hospital Bristol, following an RTA. |
| Key exclusion criteria | 1. Experienced life threatening physical injuries (Triage rating 1) 2. Were unconscious for 15 minutes or more 3. Suffer significant learning difficulties 4. Live outside 30 mile radius of RUH in Bath (so cannot attend treatment sessions) |
| Date of first enrolment | 27/04/2006 |
| Date of final enrolment | 31/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Child & Family Therapy
Bath
BA1 3NG
United Kingdom
BA1 3NG
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding
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 | 01/07/2008 | Yes | No |
Editorial Notes
18/09/2017: internal review.
