Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

Abstract

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

SUpporting wellbeing through PEeR-Befriending (SUPERB) feasibility trial: fidelity of peer-befriending for people with aphasia

“…The study was novel as one of still only a handful of aphasia trials reporting fidelity in a systematic way, based on a theoretical framework. 33 39 42 43 The study demonstrated the importance of comprehensive planning for fidelity at the outset of a trial and the need for ongoing rigorous monitoring throughout the trial to ensure an intervention is implemented as intended. Twitter Nicholas Behn @NicholasBehn, Becky Moss @BeckMoss, Sally McVicker @sallymcvicker, Abi Roper @abracabadger, Sarah Northcott @sarahnorthcott8, Shirley Thomas @DrShirleyThomas, Alan Simpson @cityalan, Kimberley Goldsmith @KimberleyGol and Katerina Hilari @KaterinaHilari…”

Treatment fidelity of technology‐enhanced reading therapy (CommuniCATE) for people with aphasia

“…Of the 12 papers generated, 6 were aphasia intervention studies which reported also on the TF of the study as part of the paper(Cherney et al 2019, Hilari et al 2019, Marshall et al 2018, Shrubsole et al 2018, Volkmer et al 2018. 5 were looking solely at the TF reporting of a specific aphasia intervention, as this paper intends to do(Ball et al 2018, Carragher et al 2019, Conlon et al 2020, Kladouchou et al 2017, Spell et al 2020). It should be noted that 3 were study protocol papers, and were therefore giving only intended TF reporting processes(Carragher et al 2019, Hilari et al 2019, Volkmer et al 2018.…”

“…More subtle aspects of dose, such as levels of practice on target items, were neglected. 7 papers explicitly addressed use of a manual to improve TF(Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2020, Spell et al 2020, Volkmer et al 2018. 9 reported use, or intended use, of videos to record the intervention and assess TF(Ball et al 2018, Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2018, Spell et al 2020, Volkmer et al 2018.…”

“…7 papers explicitly addressed use of a manual to improve TF(Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2020, Spell et al 2020, Volkmer et al 2018. 9 reported use, or intended use, of videos to record the intervention and assess TF(Ball et al 2018, Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2018, Spell et al 2020, Volkmer et al 2018. 8 explicitly addressed the use of a checklist(Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2018, Shrubsole et al 2018, Volkmer et al 2018.…”

“…9 reported use, or intended use, of videos to record the intervention and assess TF(Ball et al 2018, Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2018, Spell et al 2020, Volkmer et al 2018. 8 explicitly addressed the use of a checklist(Carragher et al 2019, Conlon et al 2020, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2018, Shrubsole et al 2018, Volkmer et al 2018. 6 of the studies that reported on TF also assessed, or planned to assess, the reliability of their results(Carragher et al 2019, Hilari et al 2019, Kladouchou et al 2017, Marshall et al 2020, Spell et al 2020, Volkmer et al 2018).…”