title: Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years.
  
  
  METHODS
  This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms.
  
  
  CONCLUSIONS
  This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information about the feasibility of delivering the treatment in UK National Health Service (NHS) settings, and its acceptability to the children and their families. This study will highlight aspects of the intervention that need improvement or modification in preparation for a full-scale evaluation in a larger sample.
  
  
  BACKGROUND
  ISRCTN35018680 , registered on 18 November 2013.
authors: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. tim.dalgleish@mrc-cbu.cam.ac.uk.|Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. tim.dalgleish@mrc-cbu.cam.ac.uk.
authors: Tim
authors: T
authors: Dalgleish
authors: Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. ben.goodall@mrc-cbu.cam.ac.uk.
authors: Benjamin
authors: B
authors: Goodall
authors: Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. isobel.chadwick@mrc-cbu.cam.ac.uk.
authors: Isobel
authors: I
authors: Chadwick
authors: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. aliza.werner-seidler@mrc-cbu.cam.ac.uk.|Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. aliza.werner-seidler@mrc-cbu.cam.ac.uk.
authors: Aliza
authors: A
authors: Werner-Seidler
authors: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. anna.mckinnon@mrc-cbu.cam.ac.uk.|Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. anna.mckinnon@mrc-cbu.cam.ac.uk.
authors: Anna
authors: A
authors: McKinnon
authors: Department of Psychology, University of Cambridge, Cambridge, UK. nm432@cam.ac.uk.
authors: Nicola
authors: N
authors: Morant
authors: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. susanne.schweizer@mrc-cbu.cam.ac.uk.
authors: Susanne
authors: S
authors: Schweizer
authors: Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. inderpal.panesar@mrc-cbu.cam.ac.uk.
authors: Inderpal
authors: I
authors: Panesar
authors: Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK. ayla.humphrey@cpft.nhs.uk.
authors: Ayla
authors: A
authors: Humphrey
authors: Medical Research Council Cognition and Brain Sciences Unit, Cambridge, UK. peter.watson@mrc-cbu.cam.ac.uk.
authors: Peter
authors: P
authors: Watson
authors: Institute of Public Health, University of Cambridge, Cambridge, UK. ll394@medschl.cam.ac.uk.
authors: Louise
authors: L
authors: Lafortune
authors: Institute of Psychiatry, Kings College London, London, UK. patrick.smith@kcl.ac.uk.
authors: Patrick
authors: P
authors: Smith
authors: Department of Clinical Psychology, University of East Anglia, Norwich, UK. r.meiser-stedman@uea.ac.uk.
authors: Richard
authors: R
authors: Meiser-Stedman
mesh_terms: D000223:Adaptation, Psychological; D000367:Age Factors; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D015897:Comorbidity; D018592:Cross-Over Studies; D004644:Emotions; D006801:Humans; D008568:Memory; D010865:Pilot Projects; D012107:Research Design; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014947:Wounds and Injuries / Q000150:complications / Q000175:diagnosis / Q000523:psychology*