Table 2.

Treatment Fidelity Strategies for Study Design.

Goal	NIH BCC description1	BIO-MUSE strategies
Goal 1: Ensure that interventions are congruent with relevant theory and clinical experience.	Operationalize interventions to reflect theory; define independent and dependent variables most relevant to the “active ingredient” of the intervention.	Intervention theory: Contextual Support Model of Music Therapy12; Self-Determination Theory13 Essential intervention elements: Intervention designed to provide optimal levels of structure, autonomy support, and support parent/child relationship through tailored delivery of music-play. Attention control condition: Designed to control for audio-visual stimulation, presence of a trained provider, and shared play activity that involves both parent and child.14
Goal 2: Ensure same treatment dose within and across conditions.	Ensure that treatment “dose” (measured by number, frequency, and duration) is adequately described and is the same for each subject within and across treatment and control conditions.	Number/frequency of sessions: Coincide with timing and length of consolidation treatment (4 weekly sessions standard risk patients; 8 weekly sessions high risk patients). Session duration: 20 min/session for ASB; 25 min for AME Between session engagement: Activity kits encourage engagement in condition-related activities outside sessions. Dose monitoring via provider field note: Providers document actual session length and participant-reported use of condition related activities between sessions. Dose confirmation: External quality assurance monitoring confirms provider-reported field note data.
Goal 3: Plan for implementation setbacks	Address possible setbacks in implementation.	Train Multiple Providers at each study site to ensure provider availability and minimize impact of turnover, absences, and illness.