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ISRCTN
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ISRCTN05595708
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ClinicalTrials.gov identifier
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Public title
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A pilot randomised trial to determine the efficacy of early cognitive behaviour therapy (CBT) versus delayed treatment for children with significant post-traumatic reactions.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0038183431
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Study hypothesis
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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?
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Ethics approval
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Not provided at time of registration
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Study design
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Pilot randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Post-traumatic disorder
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Participants - inclusion criteria
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Children aged 7 to 18 who attend the A&E departments at the Royal United Hospital Bath, and Frenchay Hospital Bristol, following an RTA.
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Participants - exclusion criteria
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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)
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Anticipated start date
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27/04/2006
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Anticipated end date
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31/05/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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20
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Avon and Wiltshire Mental Health Partnership NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Summary of outcome of one of the processes employed in the study:
Salter, E. & Stallard, P. (In Press). A pilot study to explore the effect of symptom monitoring in children and adolescents with posttraumatic stress reactions following road traffic accidents. Behavioural and Cognitive Psychotherapy.
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Contact name
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Prof
Stallard
Paul
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Address
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Department of Child & Family Therapy
RUH
Combe Park
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City/town
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Bath
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Zip/Postcode
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BA1 3NG
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Country
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United Kingdom
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Tel
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+44 01225 825075
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Fax
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+44 01225 825076
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Email
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paul.stallard@awp.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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26/08/2008
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Date ISRCTN assigned
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28/09/2007
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