Fidelity protocol for the Action Success Knowledge (ASK) trial: A psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia

Introduction: Treatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke). Methods and analysis: A novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework. Ethics and dissemination: The study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations. Trial registration number ACTRN12614000979651

Conversation as an Outcome of Aphasia Treatment: A Systematic Scoping Review

PURPOSE: Conversation-focused speech-language pathology services are a top priority for people living with aphasia, but little is known about how researchers measure conversation as an outcome of treatment. This scoping review was undertaken to systematically review the evidence regarding the measurement of conversation in aphasia studies and to identify current practices and existing gaps. METHOD: A systematic literature search was conducted for studies published between January 1995 and September 2019 in multiple electronic databases. Covidence software was used to manage search results, study selection, and data charting processes. Data were extracted from each study and then collated and organized to elucidate the breadth of approaches, tools, or procedures oriented to measuring conversation as an outcome and identify gaps in the existing literature. RESULTS: The systematic search of the literature resulted in 1,244 studies. A total of 64 studies met inclusion criteria and were included in the review. The review summarizes the various tools and procedures used to measure conversation as an outcome of aphasia intervention, including variations in data collection and analysis procedures. The review also evaluates the quality of conversation measures in terms of psychometric properties and informal measures of validity. There was a total of 211 measures used across the 64 studies. CONCLUSIONS: While there was no clear measure that was objectively superior, several measures show promise and warrant future exploration. Some of the orientations, conceptualizations, and procedures we have presented can be seen as options that might be included in a future conversation-focused core outcome set. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.21514062

Developing, monitoring, and reporting of fidelity in aphasia trials: Core recommendations from the collaboration of aphasia trialists (CATs) trials for aphasia panel

Background: Developing, monitoring, and reporting of fidelity are essential and integral components to the design of randomised controlled trials (RCTs) in stroke and aphasia. Treatment fidelity refers to the degree to which an intervention is delivered as intended and is directly related to the quality of the evidence generated by RCTs. Clear documentation of treatment fidelity in trials assists in the evaluation of the clinical implications of potential benefits attributed to the intervention. Consideration of the implementation requirements of a research-based intervention as intended in a clinical context is necessary to achieve similar outcomes for a clinical population. Despite this, treatment fidelity is rarely reported in RCTs of aphasia intervention. Aim: To describe fidelity strategies and develop core recommendations for developing, monitoring, and reporting of fidelity in aphasia intervention RCTs. Scope: Relevant conceptual frameworks were considered. The Behaviour Change Consortium comprehensive framework of fidelity was adopted. It includes five areas: study design, training providers, delivery of treatment, treatment receipt, and treatment enactment. We explored fidelity in RCTs with a range of complex aphasia interventions (e.g., ASK, Big CACTUS, COMPARE, FCET2EC, POLAR, SUPERB, and VERSE) and described how different trial design factors (e.g., phase of trial, explanatory vs. pragmatic, number and location of sites, and number and type of treatment providers) influenced the fidelity strategies chosen. Strategies were mapped onto the five areas of the fidelity framework with a detailed exploration of how fidelity criteria were developed, measured, and monitored throughout each trial. This information was synthesised into a set of core recommendations to guide aphasia researchers towards the adequate measurement, capture, and reporting of fidelity within future aphasia intervention studies. Conclusions/Recommendations: Treatment fidelity should be a core consideration in planning an intervention trial, a concept that goes beyond treatment adherence alone. A range of strategies should be selected depending on the phase and design of the trial being undertaken and appropriate investment of time and costs should be considered

Acceptability, feasibility and preliminary efficacy of low-moderate intensity Constraint Induced Aphasia Therapy and Multi-Modality Aphasia Therapy in chronic aphasia after stroke

Background: High-intensity Constraint-Induced Aphasia Therapy Plus (CIAT-Plus) and Multi-Modality Aphasia Therapy (M-MAT) are effective interventions for chronic post-stroke aphasia but challenging to provide in clinical practice. Providing these interventions may be more feasible at lower intensities, but comparative evidence is lacking. We therefore explored feasibility, acceptability, and preliminary efficacy of the treatments at a lower intensity. Methods: A multisite, single-blinded, randomized Phase II trial was conducted within the Phase III COMPARE trial. Groups of participants with chronic aphasia from the usual care arm of the COMPARE trial were randomized to M-MAT or CIAT-Plus, delivered at the same dose as the COMPARE trial but at lower intensity (6 hours/week × 5 weeks rather than 15 hours/week × 2 weeks). Blinded assessors measured aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient), word retrieval, connected speech, multimodal communication, functional communication, and quality of life immediately post interventions and after 12 weeks. Feasibility and acceptability were explored. Results: Of 70 eligible participants, 77% consented to the trial; 78% of randomized participants completed intervention and 98% of assessment visits were conducted. Fatigue and distress ratings were low with no related withdrawals. Adverse events related to the trial (n = 4) were mild in severity. Statistically significant treatment effects were demonstrated on word retrieval and functional communication and both interventions were equally effective. Conclusions: Low–moderateintensity CIAT-Plus and M-MAT were feasible and acceptable. Both interventions show preliminary efficacy at a low–moderate intensity. These results support a powered trial investigating these interventions at a low–moderate intensity

The consequences of the consequences: The impact of the environment on people with aphasia over time

Understanding the impact of the environment on the participation of people with aphasia depends on one's perspective. A long-term perspective provides a unique insight into the myriad of ways in which the environment can influence the participation of people living with aphasia over decades. In this article, the authors present the real-life story of "Hank," who has lived with aphasia for more than 15 years. The authors consider how 2 different conceptual frameworks-the International Classification of Functioning, Disability and Health and the Social Determinants of Health-account for Hank's experience. The International Classification of Functioning, Disability and Health is useful to conceptualize the range of factors that influence living with aphasia at a particular point in time. In contrast, the Social Determinants of Health is useful to conceptualize the cumulative impact of living with aphasia on long-term health and well-being. Viewing aphasia as a social condition that impacts social determinants of health has potentially wide ranging implications for service design and delivery and the role of speech-language pathologists

Comparing multi-modality and constraint-induced treatment for aphasia : A preliminary investigation of generalisation to discourse

We applied reliable communicative measures of lexical and communicative behaviours to investigate the comparative impact of multi-modality aphasia therapy (M-MAT) and constraint-induced aphasia therapy plus (CIAT Plus) on three discourse genres

Adapting therapy for a new world : Storytelling therapy in EVA Park

Background Storytelling is fundamental to human communication yet is under-represented in aphasia therapy research and clinical practice. Access to care may be one obstacle; in the broader healthcare context, remote modes of treatment delivery can increase individuals’ access to care. EVA Park is a highly novel, online platform designed with people with aphasia that has shown capacity to improve aspects of language and communication. Aims This study explored whether it is feasible to deliver a storytelling intervention in EVA Park and whether therapy brought about improvements in the content and organisation of their narratives. Changes in functional communication and technology use were also examined. Methods and procedures In a pilot feasibility study, three individuals with aphasia were recruited in the UK and Australia. Over five weeks, participants received 20 hours of therapy in EVA Park, consisting of three weekly sessions with a speech therapist and one weekly session in which the participant told the story to a volunteer who was blinded to the content of their story. A repeated-measures, case series design was used to evaluate therapy. The primary measure assessed the content of narratives elicited by novel video stimuli twice before and twice after therapy. Secondary measures investigated structural features of the video narratives and of personal narratives. Functional communication was assessed with the Communication Activities of Daily Living assessment, and technology use was probed via a Technology Screen. Outcomes and results Delivery of storytelling therapy via EVA Park was feasible; technology challenges arose and were resolved using multiple strategies. Following therapy, participants’ storytelling improved in content, with a large effect size for the group, and in structure. Generalisation to personal narratives was not observed. Some improvements were seen in functional communication. Conclusions Storytelling therapy delivered via an online platform is feasible and may improve the content and organisation of participants’ storytelling, with some evidence of generalisation to functional communication