Treatment Integrity and Differentiation in the Very Early Rehabilitation in SpEech (VERSE) trial

Background Key elements of treatment fidelity include treatment integrity (adherence to the treatment protocol) and treatment differentiation (the difference in treatment ingredients in the control and intervention groups). The Very Early Rehabilitation in SpEech (VERSE) trial established treatment fidelity at the macro level for key components of therapy. Aims To complete a detailed analysis of treatment integrity and differentiation at the utterance level of a therapeutic interaction. Methods This was an observational study of therapy videos collected as part of the VERSE trial. Participants were people with aphasia in the very early phase of recovery post stroke (n = 44) and speech-language pathologists (n = 25). Therapist video recorded sessions in the intensive arms of the trial (VERSE-prescribed therapy and Usual Care Plus) and 53 therapy videos (12%) were randomly selected for analysis. Therapy sessions were transcribed, and key measures reflective of therapeutic inputs and client acts were coded to determine treatment integrity and differentiation. A descriptive analysis and a Welch's t-test for unequal variances were used to analyse the sessional data. Results Therapists in the VERSE (prescribed intervention) arm of the study, were highly adherent to the treatment protocol at the utterance level (M = 97%). Treatment differentiation between the intensive conditions in this sample was not achieved for cueing and error handling suggesting the treatment delivered between groups was similar. Conclusions Within this sample, treatment integrity to the prescribed condition was maintained. Despite significant differences on a broad level, there was not significant differentiation in the therapy provided in the two arms of the trial at the utterance level. This result supports the null finding in effectiveness between the two intensive arms of the treatment as potential key measures were not different in dosage.