Table 5.
Treatment Fidelity Strategies for Delivery of Treatment.
| Goal | NIH BCC description1 | BIO-MUSE strategies |
|---|---|---|
| Goal 1: Control for provider differences. | Monitor and control for subject perceptions of nonspecific treatment effects across intervention and control conditions. | Recorded sessions: All sessions audio- or video-recorded. |
| External QA monitoring: Includes provider interaction style and attributes. | ||
| Provider selection: Hire providers that demonstrate supportive interaction styles and have experience working with young children and families. | ||
| Same providers: Providers deliver both intervention and attention control conditions. | ||
| Qualitative interviews: Provides parent perspectives about their experience with providers. | ||
| Goal 2: Reduce differences within treatment. | Ensure that providers in the same condition are delivering the same intervention. | Standardized study protocols: Manualized protocols for each study condition. |
| Recorded sessions: All session audio- or video-recorded. | ||
| Self- and external QA monitoring: Monitoring ensures accurate and consistent delivery across providers. | ||
| Standardized QA checklists: Lists essential elements for each study condition. | ||
| Goal 3: Ensure adherence to treatment protocol. | Ensure that study conditions are being delivered as intended including content and treatment dose. | Self and external QA monitoring: Sustained monitoring ensures accurate and consistent delivery of study conditions over time. |
| Standardized QA checklists: Lists essential elements for each study condition. Used during session delivery and self/external QA monitoring. | ||
| Individualized supervision: Review omissions and/or protocol deviations with providers on an individual basis. | ||
| Monthly provider calls: Review challenges and successes experienced during session delivery; discuss protocol omissions or deviations. | ||
| QA checklists: Support protocol adherence/deviation tracking across providers and study conditions. | ||
| Provider field notes: Providers capture date, time, and duration for study sessions in electronic field notes. | ||
| Goal 4: Minimize contamination between conditions. | Minimize contamination across treatment/control conditions, especially when implemented by same provider. | Standardized study protocols: Manualized protocols for each study condition. |
| Recorded sessions: All session audio- or video-recorded. | ||
| Self and external QA monitoring: Monitoring ensures accurate and consistent delivery without cross-contamination. Monitoring for biased language when answering parent questions about study conditions. | ||
| Standardized QA checklists: Lists essential elements for each study condition. Used during session delivery and self/external QA monitoring. | ||
| Theory/rationale for study conditions: Train providers on theory and rationale underlying structure/delivery of intervention and low dose attention control conditions. | ||
| Non-biased language training: Equip providers with non-biased language and explanation to address participant questions about study conditions. |