Title: A pilot randomised clinical trial of trauma-focused cognitive behaviour therapy for posttraumatic stress disorder (PTSD) in young children aged 3-8 years
Funder: Department of Health (England)

Abstract: Background: Traumatic events (e.g., serious accidents) are experienced by up to 2/3 of children by age 16. A significant degree of this exposure occurs in pre-school and early school years, even when excluding abuse trauma. Many (10-40%) of these younger children exposed to non-abuse traumas are severely affected and develop Posttraumatic Stress Disorder (PTSD) . PTSD is a profoundly distressing and disabling anxiety disorder that markedly impairs educational, social and daily functioning, and rarely remits in children without treatment. Although current NICE recommended treatments for PTSD across the lifespan comprise psychological interventions, there are currently no such treatments available for this young age group. Despite the clear clinical demand, the majority therefore go untreated. There is thus an urgent need for treatment development. In older children and adults a form of psychological treatment - Trauma Focused Cognitive Behaviour Therapy (TF-CBT) – has proved very effective in the treatment of PTSD. Based on our extensive work in older children, we have adapted TF-CBT to provide a 12-session intervention suitable for young children (TF-CBT-YC), aged 3-8 years, experiencing single-incident traumas. Our pilot work (Figure 1) supports TF-CBT-YC’s strong potential for patient benefit in this younger age group. Research aims: Our principal aim is to conduct the first European pilot randomised clinical trial of a psychological treatment - TF-CBT-YC - for PTSD in young children aged 3-8 years experiencing single-incident traumas. The trial evaluates the feasibility of the TF-CBT-YC protocol in the UK NHS, its acceptability to clinicians and families, its potential cost-effectiveness , and will provide a point estimate of efficacy of the intervention to treat PTSD. A secondary aim is to gather data to develop a sensitive screening tool to identify those young children at risk of later PTSD following a trauma. NICE recommends such screening in the aftermath of trauma but there are currently no suitable measures for children. Plan of investigation: We propose a two-arm pilot randomised clinical trial comparing TF-CBT-YC with a wait list (WL) condition on a primary outcome of PTSD diagnosis according to developmentally sensitive criteria assessed using structured interview (the Diagnostic Infant and Preschool Assessment [DIPA]), along with a range of secondary outcomes. A half-cross-over design will be employed where those in the WL arm will be offered the intervention after their period of waiting. All children receiving the intervention will then be followed up again at three months. Feasibility and acceptability of the intervention will be assessed through a mixture of quantitative and qualitative methods. Health economic data will be acquired through structured questionnaires. Participants will be children aged 3-8 years who have experienced a discrete non-abuse trauma and their families. We aim to recruit 44 children (22 per arm), leaving 17 per arm assuming 20% attrition, for the key pre- to post-treatment primary outcome comparison across groups. Our main source of recruitment will be Addenbrooke’s Hospital Emergency Department (AH-ED), though a number of other recruitment sources have also been established. AH-ED recruitment will involve two phases allowing us to gather data about which profile of early symptoms (2-4 weeks post-trauma) most sensitively predicts later PTSD (at 3 months). This will be used to develop the much-needed screening instrument for early detection of those at risk. Outcomes from the trial will inform a final iteration of TF-CBT-YC treatment manual development in preparation for a subsequent definitive trial, although we also anticipate more immediate dissemination of the intervention. Patient benefit: Developing an evidence-based intervention where none exists, but where there is a clear, substantive and identified clinical need, has a strong potential for patient benefit, providing much needed clinical support to an under-served group.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH