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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
There are, however, variants of case studies that provide a more robust examination of intervention effects under more controlled settings. “N-of-1” trials, also known as single-case experimental designs (SCEDs), may comprise a single participant who, for example, receives multiple interventions given randomly or in a planned sequence to assess their effectiveness (Evans et al., 2014). SCED studies more commonly comprise multiple participants, for example, allocated at random to different durations of a pre-treatment monitoring phase, followed by intervention in a subsequent phase. This form of “multiple baseline” design permits not only replication of baseline (A) to intervention (B) within-subject treatment (A-B) effects but also between-subject comparison across the staggered baselines (A1-B, A2-B, A3-B). This comparison may then demonstrate, both visually and inferentially, that treatment response systematically occurs upon treatment administration.
One by One
Published in Rens van de Schoot, Milica Miočević, Small Sample Size Solutions, 2020
A special category of single-case designs is derived if the replications are preplanned and simultaneous. In a so-called “multiple-baseline across-participants design”, several AB phase designs are conducted at the same time, and the B phases are started at different “staggered” moments. For example, Figure 6.4 shows the results of a four-week multiple-baseline design across three children for evaluating the effect of a behavioral intervention on the general distress level of the children as assessed daily by the staff at a daycare center. The intervention is started after the first week for the first child, after the second week for the second child, and after the third week for the third child. If there is a functional relation between the intervention and the distress, then the distress is expected to decrease after the intervention is implemented for the target child, but not for other children. In order to check for this differential effect, the results of all children are monitored simultaneously. If there would be a more general external cause of the decrease in distress, then all children would be affected (e.g., by a change in policy at the daycare center). Hence in multiple-baseline across-participants designs both within-AB and between-AB comparisons are possible and important. Simultaneous replication designs, in contrast to sequential replication designs, have the advantage that the confounding effects of “history” (external events) can be controlled by the between-series comparisons (Onghena & Edgington, 2005).
Rehabilitation of Apraxia in Adults and Children
Published in Barbara A. Wilson, Jill Winegardner, Caroline M. van Heugten, Tamara Ownsworth, Neuropsychological Rehabilitation, 2017
Caroline M. van Heugten, Chantal Geusgens
Sound production treatment is believed to be the treatment of choice for AOS according to some authors (Wambaugh et al., 2013, 2014b). In a multiple baseline design across participants and behaviours with four participants, different intensities and schedules of practice were evaluated. Positive changes in accuracy of articulation for all participants and all methods were shown (Wambaugh et al., 2013). In another study the same authors investigated the differential effects of blocked versus random practice of sound production treatment in six participants (Wambaugh et al., 2014a). Comparable effects of both practice methods were found in terms of increasing the accuracy of articulation but only the random practice version led to maintenance of effects in two participants. The same group also combined Aphasia and Apraxia of Speech Treatment (CAAST) targeted at language and speech production simultaneously, with treatment techniques derived from Response Elaboration Training and Sound Production Treatment (Wambaugh et al., 2014b). Since no unequivocal results of its effects were found, the authors suggest a modification of CAAST needs to be developed and further evaluated.
Naturalistic teaching approach to develop spontaneous vocalizations and augmented communication in children with autism spectrum disorder
Published in Augmentative and Alternative Communication, 2021
Nouf M. Alzrayer, Rashed Aldabas, Abdulkarim Alhossein, Hanan Alharthi
A multiple baseline design across participants (Baer, Wolf, & Risley, 1968) was used to evaluate the effects of the intervention. Baseline data were collected concurrently from all participants. When the augmented requesting and spontaneous vocalization data were stable during baseline (i.e., no more than 5% variability on the dependent measures) in the last three data points for one of the participants, the intervention was introduced to the selected participant. When the data for both dependent measures were stable for the intervention phase, the intervention was implemented for the next participant until all of the participants received the intervention. When the participants reached the acquisition criterion (i.e., at least one request per min across three consecutive sessions on either modality), maintenance data were collected from all participants. A multiple follow-up probe design was used to evaluate maintenance (Barrios & Hartmann, 1988; Schlosser & Lee, 2000). The study was approved by the appropriate ethics committee.
Utilizing the Performance Diagnostic Checklist – Human Services to Assess and Improve Employee Performance on Mand Training: A Replication
Published in Journal of Organizational Behavior Management, 2020
Julie L. Melendez, Jonathan Tarbox, Svada Parhimoon
Bowe and Sellers (2018) utilized the PDC-HS to assess inaccurate error-correction procedures among school paraprofessionals. After the completion of the PDC-HS by three preschool teachers, the intervention identified was behavioral skills training (BST). The authors also implemented interventions not indicated by the PDC-HS to compare effectiveness of both treatments. The nonindicated interventions were task clarification and prompting. Bowe and Sellers (2018) implemented the nonindicated interventions first, then introduced the PDC-HS indicated intervention across all participants. A concurrent multiple-baseline design across participants was utilized to analyze the effect of both interventions. The results demonstrated that the PDC-HS indicated intervention was effective, whereas the nonindicated interventions were less effective at improving performance.
Attention Process Training-3 to improve reading comprehension in mild aphasia: A single-case experimental design study
Published in Neuropsychological Rehabilitation, 2020
Jaime B. Lee, McKay Moore Sohlberg, Beth Harn, Robert Horner, Leora R. Cherney
A non-concurrent multiple baseline SCED was employed to examine potential treatment effects. In a traditional multiple baseline design, the baseline phase is initiated at the same point in time across participants, and the introduction of the intervention is staggered on different tiers to control for possible threats to internal validity. The non-concurrent multiple baseline design offers flexibility for continuous enrolment in a study and for eligible participants to start baseline at different points in time. Extending the length of the baseline condition across participants reduces threats to internal validity (Kennedy, 2005). The design of the current study reflected recent standards aimed at strengthening the methodological rigour of single-case intervention research (Kratochwill et al., 2013). For example, including six participants in the current study allowed the potential for demonstration of effect at six different points in time. This sample size also allowed for pairing participants (i.e., two participants run on the same baseline and treatment schedules). Decisions regarding the scheduling of baseline and when to initiate the treatment phase were based on participants’ responses to intervention and visual inspection of plotted data.