Efficacy and moderators of efficacy of trauma-focused cognitive behavioural therapies in children and adolescents: protocol for an individual participant data meta-analysis from randomised trials

Abstract

IntroductionTrauma-focused cognitive behavioural therapies are the first-line treatment for posttraumatic stress disorder (PTSD) in children and adolescents. Nevertheless, open questions remain with respect to efficacy: why does this first-line treatment not work for everyone? For whom does it work best? Individual clinical trials often do not provide sufficient statistical power to examine and substantiate moderating factors. To overcome the issue of limited power, an individual participant data meta-analysis of randomised trials evaluating forms of trauma-focused cognitive behavioural therapy in children and adolescents aged 6–18 years will be conducted.Methods and analysisWe will update the National Institute for Health and Care Excellence guideline literature search from 2018 with an electronic search in the databases PsycINFO, MEDLINE, Embase, Cochrane Central Register of Controlled Trials and CINAHL with the terms (trauma* OR stress*) AND (cognitive therap* OR psychotherap*) AND (trial* OR review*). Electronic searches will be supplemented by a comprehensive grey literature search in archives and trial registries. Only randomised trials that used any manualised psychological treatment—that is a trauma-focused cognitive behavioural therapy for children and adolescents—will be included. The primary outcome variable will be child-reported posttraumatic stress symptoms (PTSS) post-treatment. Proxy-reports (teacher, parent and caregiver) will be analysed separately. Secondary outcomes will include follow-up assessments of PTSS, PTSD diagnosis and symptoms of comorbid disorders such as depression, anxiety-related and externalising problems. Random-effects models applying restricted maximum likelihood estimation will be used for all analyses. We will use the Revised Cochrane Risk of Bias tool to measure risk of bias.Ethics and disseminationContributing study authors need to have permission to share anonymised data. Contributing studies will be required to remove patient identifiers before providing their data. Results will be published in a peer-reviewed journal and presented at international conferences.PROSPERO registration numberCRD42019151954.

Predictors and moderators of treatment outcome for single incident paediatric PTSD: a multi-centre randomized clinical trial

“…Moreover, new statistical approaches need to be considered, because individual RCTs often lack the power to examine the contribution of specific factors to clinical outcomes and have produced inconsistent results across studies. Individual participant data meta-analysis (IPD-MA) may provide a more reliable means to address the question ‘what works for whom’, due to combined data sets and sufficient statistical power (De Haan et al, 2021 ). Future studies may also consider combining baseline patient characteristics to create a single strong moderator as a more powerful and precise measure to detect differential treatment responses (Wallace, Frank, & Kraemer, 2013 ) or consider the use of the Personalized Advantage Index approach (PAI; DeRubeis et al, 2014 ), which is a treatment selection algorithm, that predicts the optimal treatment option for an individual patient.…”

Causal and common risk pathways linking childhood maltreatment to later intimate partner violence victimization

“…Future studies should examine how psychological processes impacted by maltreatment elevate risk of harmful intimate relationships. They should also assess the effect of interventions like trauma-focused cognitive-behavioral therapy on interpersonal outcomes, including the development of safe intimate relationships following maltreatment (115,116). Progress in this research is indispensable for enhancing prevention efforts and interrupting cycles of revictimization.…”

Data sharing and re-use in the traumatic stress field: An international survey of trauma researchers

“…Recent developments in combining ‘long tail’ data can also be seen within various initiatives in the field of traumatic stress, as well as mental health more broadly (Sadeh et al, 2023 ). With regard to interventions, there are now projects integrating individual participant data (IPD) from treatment trials that target PTSD in adults (Wright et al, 2022 ) or children (de Haan et al, 2021 ), PTSD with substance use disorders (Hien et al, 2023 ), or traumatic grief ( https://people.utwente.nl/l.i.m.lenferink?tab = projects ). Other initiatives bring together IPD from prospective studies of traumatic grief (Boelen & Lenferink, 2022 ) or of individuals – adults or children – with recent trauma (Kassam-Adams et al, 2020 ; Lai et al, 2021 ; Shalev et al, 2019 ).…”