Contact information
Type
Scientific
Primary contact
Prof Stallard Paul
ORCID ID
Contact details
Department of Child & Family Therapy
RUH
Combe Park
Bath
BA1 3NG
United Kingdom
+44 01225 825075
paul.stallard@awp.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0038183431
Study information
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.
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
27/04/2006
Overall trial end date
31/05/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
20
Participant 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)
Recruitment start date
27/04/2006
Recruitment end date
31/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Child & Family Therapy
Bath
BA1 3NG
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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
Funders
Funder type
Government
Funder name
Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding
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
Basic results (scientific)