| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN05595708 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0038183431 |
| Public 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. |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: Post-traumatic disorder |
| Study hypothesis | What is the efficacy of early, brief trauma-focused CBT for the treatment of significant acute posttraumatic reactions in child RTA victims? |
| Design/methodology | Pilot randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 27/04/2006 |
| Anticipated end date | 31/05/2007 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | RCT - A [immediate course of psychotherapeutic sessions] B - [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. |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Avon and Wiltshire Mental Health Partnership NHS Trust
AWP Partnership Mental Health NHS Trust R&D Project grant
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Stallard Paul |
| Contact details | Department of Child & Family Therapy
RUH
Combe Park
Bath
United Kingdom
BA1 3NG |
| Contact telephone | +44 01225 825075 |
| Contact fax | +44 01225 825076 |
| Contact email | paul.stallard@awp.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN05595708 |
| Date last extracted from ISRCTN register | 17/04/2008 |
