Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy

Abstract

Background More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes. Methods Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness. Discussion This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting. Trial registration ClinicalTrials.gov registration number NCT04451161. Registered on June 30, 2020.

A cluster randomised effectiveness-implementation trial of an intervention to increase the adoption of PAX Good Behaviour Game, a mental health prevention program, in Australian primary schools: Study protocol

“…In light of the literature, strategies that facilitate this knowledge translation will lead to better outcomes for children and young people [ 31 , 59 ]. More broadly, this protocol provides learning about how to conduct hybrid effectiveness-implementation trials, which are an emerging area of research as evidenced by the numerous hybrid trial protocols published between 2019 and 2021 [ [60] , [61] , [62] , [63] , [64] , [65] , [66] , [67] , [68] , [69] ].…”

Understanding the Role of Clinical Champions and Their Impact on Clinician Behavior Change: The Need for Causal Pathway Mechanisms

“…These models were selected to inform the proposed causal pathways due to their relevance to understanding adult behavior change and their routine application in implementation science to address the research-to-practice gap (50)(51)(52). These theories clearly explicate individual-level factors that impact behavior change and can also account for the role of others within the implementation context, such as clinical champions, in influencing both implementation intentions and action (e.g., through social norms).…”

“…Additionally, the HAPA model provides a unique contribution beyond the TBP by also accounting for behavioral engagement and other factors that address the intention-behavior gap (56). Whereas other adult-focused behavioral change theories describe constructs that predict overall behavior intention, the HAPA model can also outline potential causal pathway mechanisms relevant to providers who actively transition from intention to behavioral enactment and then need to sustain that behavior enactment over time (51,56).…”

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), Cognitive Behavioral Intervention on Trauma in Schools (CBITS), and Other Promising Practices in the Treatment of Post-Traumatic Stress Disorder in Children and Adolescents: Evidence Evaluation

“…In such cases, another intervention that does not prioritize trauma exposure but focuses on the practical management of the deviant behaviors would have advantages [13,63,64]. Finally, it is not clear whether the application of TF-CBT in the school environment ensures its accuracy because organizational (e.g., organizational culture and implementation climate) and individual factors of the providers (especially attitudes) can hinder its implementation and effectiveness [65][66][67][68].…”