Reporting on novel complex intervention development for adults with social communication impairments after acquired brain injury

Abstract

Purpose: Interventions are often poorly described in published controlled trials, with relatively little information regarding intervention development, content and fidelity. This makes it difficult to conduct replication studies, interpret and compare findings across studies and for therapists to deliver the intervention in clinical practice. Complete reporting of interventions (including fidelity) is now recommended for treatment studies, and this standardized approach is achieved using the Template for Intervention Description and Replication (TIDieR). The aim of this article is to describe the multi-phase process of developing a novel intervention for adults with acquired brain injury (ABI) and report on the findings from involving practicing therapists in this process.

Methods: Phase 1 involved a review of relevant literature and specifying the intervention as a prototype intervention manual. Phase 2 comprised a focus group with eight practicing therapists exploring their experiences and perceptions of the intervention, potential active components, and essential elements; it also included a review of the prototype manual. Data from the focus group discussion was transcribed and analyzed thematically. Phase 3 investigated actual fidelity of the intervention undertaken, achieved by observers viewing videoed sessions and appraising against the fidelity checklist, which was then analyzed using Cohen's kappa.

Results: Project-based intervention was defined as having six essential elements: a project or tangible end product focus; group-based intervention; individualized communication-based goals; communication partner involvement; acknowledgement and support of participants' cognitive ability; and consideration and plan to address impaired awareness. Analysis of focus group data revealed four themes of essential elements; group context; therapeutic skills; and manual core components and informed the development of a fidelity checklist with 13 essential and 6 desirable criteria. Fidelity assessed using percent agreement was acceptable for almost all rater pairs; where significant, Kappa coefficients had values ranging from poor to excellent (k = 0.34-1.0) depending on rater pair and session.

Discussion: The TIDieR framework provided a clear systematic approach for the complete description and reporting of a complex communication intervention for people with ABI. This article comprehensively described the development and manualisation of intervention in collaboration with practicing therapists which can be used for future testing. In addition, the process undertaken has the potential to inform rehabilitation researchers in other fields on the development of complex interventions.Implications for rehabilitationThe results of this study detail the steps needed to describe an intervention, from the identification of the essential elements through to the creation of a manual and checklist to show fidelity. The process provides a starting point for other rehabilitation researchers developing complex interventions.This article provides a clear and comprehensive description of a novel intervention containing six essential elements for people with acquired brain injury presenting with communication impairments.Project-based intervention is one intervention, which intends to help improve communication skills and quality of life in people with acquired brain injury.This study highlights the important role practicing therapists can play in the creation of an intervention manual and fidelity checklist and in ensuring that sufficient detail is provided to help therapists implement the intervention into clinical practice.

Keywords: Complex intervention development; brain injury; clinical trial; communication; fidelity.