Implementing NIH Behavior Change Consortium Treatment Fidelity Recommendations in a Multi-Site Randomized Controlled Trial of an Active Music Engagement Intervention for Young Children with Cancer and Parents

Abstract

Treatment fidelity is the use of methodological strategies to monitor and enhance reliability and validity of behavioral intervention trials. Despite availability of guidelines and checklists, treatment fidelity remains underreported, hindering evaluation, interpretation, and cross-study comparisons. Treatment fidelity is particularly important for music interventions given the inherent complexity of musical stimuli and flexibility required for tailored delivery. The purpose of this paper is to define and describe treatment fidelity strategies for our trial of a music-based play intervention for young children with cancer and parents grounded in the NIH Behavior Change Consortium Treatment Fidelity Recommendations. We report strategies for all 5 areas: study design, training providers, delivery of treatment, receipt of treatment, and enactment of treatment skills. We also discuss 4 challenges our team encountered, including: (1) standardizing live music delivery, (2) defining boundaries for tailored intervention delivery, (3) managing extended time between participants, and (4) minimizing risk for bias. This paper expands on current fidelity literature and may provide a working model for other investigators examining dyadic and/or active music interventions.

Protocol and biomarker strategy for a multi-site randomized controlled trial examining biological mechanisms and dosing of active music engagement in children with acute lymphoblastic leukemia and lymphoma and parents

“…Specific strategies for the five specified fidelity components (design, provider training, treatment delivery, treatment receipt, and treatment enactment) are central to ensuring study rigor and reproducibility. A description of treatment fidelity strategies for this trial, including strategies to reduce risk for bias and contamination between conditions, are detailed in a separate publication [ 37 ].…”

“…Methods for this trial are grounded in our previously published work including several pilot studies [33][34][35][36] and a manuscript that details of our treatment fidelity strategies [37].…”

“…Although total session length is not equivalent, the amount of audio-visual stimulation is similar across groups, with the additional 10 min in AME attributed to assessment and educational activities that are unique to that condition. In addition to in-person sessions, participants take home a music-play or audio-storybooks kit to encourage between session use of the condition-related activities [33][34][35][36][37].…”

Interaction-focused music therapy with cancer-affected children and their significant others: a randomized controlled feasibility study with subsequent intervention (INMUT)

“… Quantitative studies : In their RCT, Robb et al report improvement in health outcomes of courageous coping, social integration, and family environment during high-risk cancer treatment using therapeutic music video interventions [ 10 ]. Another RCT and a single case design pilot study from Robb et al point out the positive effects of active music interventions on multiple biomarkers to improve understanding of dose–response effects [ 20 , 21 ], as well as treatment fidelity in music-based play interventions for young children with cancer and their parents [ 22 ]. In addition, a pilot RCT by Robb et al investigated the feasibility and acceptability of parent-delivered active music engagement.…”