Award Title: Cognitive Behavioural Therapy for the treatment of post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors: a phase II randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Background Posttraumatic Stress Disorder (PTSD) is a profoundly distressing and disabling psychiatric disorder that markedly impairs educational, social and daily functioning. PTSD is particularly severe, complex and enduring following multiple trauma exposure such as sexual/physical abuse, witnessing domestic violence or community violence. The current NICE-recommended treatment for PTSD in youth is a form of psychological treatment - Trauma Focused Cognitive Behaviour Therapy (TF-CBT). However, the evidence base for TF-CBT in youth exposed to multiple traumatic experiences is limited and there have been no UK randomised controlled trials (RCTs) of interventions for this population. NHS Child and Adolescent Mental Health Services (CAMHS) staff frequently report concern over best practice for this group, and treatment choice is not consistent with the current (albeit limited) evidence base. NICE, as well as recent narrative, systematic and Cochrane reviews, concur that there is an urgent need for further treatment development, supported by clinical trial evidence. The applicant's extensive work with children with PTSD following single incident traumas (traffic accidents, assaults) has led to the development of a TF-CBT protocol - the Triple M model of CBT (CBT-3M) -h; that has now been adapted to be suitable for children with PTSD following exposure to multiple trauma experiences. A case series study supports CBT-3M's strong potential for patient benefit in this population. The current proposal is therefore to conduct an RCT of CBT-3M for young people with PTSD following multiple trauma exposure. Research Objectives The primary objective of Study 1 is to evaluate the effectiveness of CBT-3M, delivered by front-line clinicians in routine settings for the treatment of PTSD in youth exposed to multiple trauma. The secondary objectives of this study are to provide preliminary evaluations of: a) the cost-effectiveness of CBT-3M; b) its mechanisms of action; and c) factors that may limit or facilitate the adoption of CBT-3M within routine care. Study 2 will evaluate how this population is currently treated in CAMHS, and the capacity of CAMHS to implement an evidence-based intervention such as CBT-3M. Plan of investigation Study 1 is a pragmatic, clinic-based RCT that will test the effectiveness of CBT-3M against treatment as usual (TAU). The design is a patient-level, single blind, two-arm, parallel pragmatic randomised controlled trial examining CBT-3M vs. TAU. Participants will be children and adolescents aged 8-17 years who have PTSD following exposure to multiple traumas. We will recruit 120 children and adolescents (60 per arm, 48 if 20% attrition is assumed) from CAMHS in East Anglia. The primary outcome variable will be PTSD severity, as assessed by the child PTSD routine outcome monitoring tool at post-treatment (i.e. 4 months post-randomisation). The secondary outcomes will be PTSD diagnosis, anxiety, depression, quality of life and parent-reported well-being. Embedded quantitative measures will allow for preliminary evaluations of the cost-effectiveness of CBT-3M and mechanisms of action. Qualitative data will be collected from a sub-set of participants receiving CBT-3M, treatment drop outs, parents/carers, clinicians and referrers; these data will identify potential obstacles or facilitators for implementation in routine care. Study 2 will use questionnaire surveys and semi-structured interviews with trial clinicians (from within the trial and UK-representative NHS Trusts), referrers, service managers and commissioners to index the current treatment offered to youth with PTSD following multiple trauma exposure, and the preparedness of NHS services to deliver evidence-based treatments (such as CBT-3M) to this group. Patient Benefit Evaluating an intervention for a population where there is substantive and identified clinical need has a strong potential for patient benefit. The proposal has scope for dramatically improving quality of care and cost-effectiveness for an under-served group, by equipping CAMHS services with an implementable treatment approach.

Lay Abstract: Background to the research Many tens of thousands of children and young people are growing up in households where they are subjected to sustained abuse and domestic violence, or experience repeated violence in their schools and local communities. The effects of these experiences can be highly damaging and in many cases may lead to life-long mental and physical health problems. Young people who develop post-traumatic stress disorder (PTSD) following these sorts of experiences appear to be particularly vulnerable to significant difficulties. PTSD is a highly disturbing condition that causes significant difficulties for young people and can last for many years. Despite the clear needs of this population, no UK studies have examined how this young people with PTSD following multiple trauma exposure might be treated in the NHS. Previous research by the applicant and his colleagues suggest that a psychological (i.e. talking) therapy called cognitive behavioural therapy (CBT) is a powerful treatment for children and people who have developed PTSD following 'one-off' traumas (e.g. motor vehicle collisions, violence, accidental injuries). This treatment has been carefully developed to target the particular mechanisms that keep PTSD going. However, the existing trials of this intervention have been conducted in highly specialist research clinics by 'expert' therapists, rather than front-line NHS settings. Moreover, these trials have not included young people with PTSD following multiple trauma experiences (e.g. abuse, domestic violence). A recent pilot study conducted by the applicant suggests that this CBT package is acceptable to this population, and delivers significant improvements in PTSD symptoms. Aims of the research The research will involve two studies. The primary aim of Study 1 is to see if a CBT package is an effective treatment for PTSD in young people who have experienced multiple traumatic experiences. In particular, we want to see if this treatment is effective when delivered by front-line NHS clinical staff (e.g. nurses, caseworkers, occupational therapists, family therapists) in normal clinical settings (i.e. Child and Adolescent Mental Health Services or 'CAMHS'). The secondary aims of this study are to ask the following questions: i. Is CBT a cost-effective treatment for PTSD in this group of young people? ii. How does CBT bring about clinical improvement in young people with PTSD? iii. What do young people, their families and CAMHS staff think of this treatment? This will help us to see how CBT might be used to treat PTSD in young people seen in CAMHS services throughout the UK. The aim of Study 2 is to examine how health and social care services are set up and currently care for young people with PTSD following multiple trauma exposure. Design and methods used Study 1 of the proposed Fellowship is a randomised controlled trial comparing a CBT package to 'treatment as usual' (i.e. normal clinical practice) for 8-17 year old young people with PTSD following exposure to multiple traumatic experiences. Young people allocated to receive CBT will receive up to 15 sessions of therapy. The main outcome measure will be the routine questionnaire for assessing PTSD symptoms in children and young people in the NHS, assessed at the end of therapy. Additional questionnaires and interviews will be used to address the secondary aims of the research. In Study 2, CAMHS staff will be surveyed to see how this population of young people are typically cared for, and what skills they currently have to support them. In particular, the views and experiences of referrers, NHS and social staff, service managers and commissioners will be investigated so as to explore how services might be better structured to effectively support young people with PTSD following multiple trauma experiences. Patient and public involvement (PPI) Young people belonging to the PPI group (inspire) of the local mental health trust will attend the Trial Management Group (TMG), serve on the Trial Steering Committee and provide input on how to best share the study findings. The Young People's Mental Health Advisory Group will review trial measures and setup, and help with the dissemination of results. Participants in the recently completed pilot study of this intervention will review the study methodology methods and tools. Local NHS clinicians and third sector representatives (e.g. from domestic violence support groups) will also attend TMG meetings and aid the process of disseminating the study findings. Dissemination In addition to publishing trial findings in peer-reviewed academic journals, study findings will be disseminated through national training workshops, on-line resources (e.g. webinars), guidelines for clinical teams and a report on developing appropriate services (for service managers and commissioners).

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.3 MANAGEMENT AND DECISION MAKING
Health Categories: MENTAL HEALTH