A randomised controlled efficacy trial of trauma-focused cognitive behaviour therapyfor posttraumatic stress disorder (PTSD) in young children aged 3-8 years

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 condition 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 adapted TF-CBT to provide a 12-session intervention suitable for young children (TF-CBT-YC), aged 3-8 years, experiencing single-incident traumas. To begin to evaluate TF-CBT-YC we carried out a randomised controlled feasibility trial (RCT), funded by the NIHR RfPB scheme, relative to care-as-usual (CAU) in the UK NHS to evaluate whether a larger efficacy trial was indicated and tractable. Our feasibility trial results showed that a fully-powered efficacy trial is feasible in terms of recruitment and retainment of families, coordination with NHS services, and acceptability to children and their carers, and to the clinicians taking part. The results also provided a strong preliminary signal of likely efficacy for TF-CBT-YC in treating PTSD-YC with 78% of children receiving TF-CBT-YC losing their PTSD diagnosis, relative to 10% in CAU (Cohen s d=2.10) Research Aims: Our principal aim is to carry out a fully-powered, multi-centre efficacy trial using broadly the same trial design parameters as our feasibility work, Plan of Investigation: We propose a two-arm randomised controlled efficacy trial comparing TF-CBT-YC with CAU on a primary outcome of PTSD diagnosis at 3-Month Follow-Up according to developmentally sensitive criteria assessed using structured interview (the Diagnostic Infant and Preschool Assessment [DIPA]), along with a range of secondary outcomes. Participants will be children aged 3-8 years who have experienced a discrete non-abuse trauma and their families. We aim to recruit 80 children (40 per arm), leaving 30 per arm assuming 25% attrition, for the key primary outcome comparison across arms. This sample size provides 90% power to detect reliable effects based on conservative estimates from our prior trials. PPI: We have, and will, work closely with our PPI Co-Applicant (AF) to recruit and retain families and deliver an intervention that is fundamentally sensitive to the needs of this vulnerable clinical group. The lived experience of trial participants will be assessed through qualitative interviews. Outputs: Should the proposed trial establish efficacy for TF-CBT-YC in 3-8 year olds, this would meet a clearly identified clinical need as there are no evidence-based NICE-recommended interventions across this age range.