Parent resolution of diagnosis and intervention fidelity in a parent-delivered intervention for pre-school children with autism: A mixed methods study

Background: There is growing interest in parent-delivered interventions (PDI) for children with autism. Treatment fidelity has been associated with child outcomes in PDI but little is known about what impacts fidelity. One factor not previously examined is parents' resolution to the autism diagnosis which involves adjusting expectations about the child and sensitively responding to their cues, strengths and needs. Relatively little is known about resolution in the context of autism but there is evidence of an association between resolution and parent wellbeing. Method: The study adopted a mixed methods approach to examine whether there is an association between PDI fidelity and parent resolution to diagnosis, and whether resolution is associated with parent wellbeing. Parents of 31 preschool children diagnosed with autism who attended up to 12 Parent-delivered Early Start Denver Model (P-ESDM) coaching sessions participated in the study. A thematic analysis of parent interviews was also undertaken to identify themes raised by resolved and unresolved parents in interviews. Results: There was no difference in overall mean fidelity scores between resolved and unresolved parents. Those classified as resolved had lower depression scores and parenting stress scores than parents classified as unresolved. The qualitative analysis revealed that parents' perceptions of their child's progress and their hopes for the future appeared to distinguish resolved and unresolved parents. Conclusions: Findings suggest that parent wellbeing and child progress may predict resolution which was not related to parent treatment fidelity in this study. Parent wellbeing and resolution status should be assessed at entry to PDI.

Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity.

Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.

The Necessary Thread of Mindfulness Intervention Fidelity Assurance: Enabling an Organizational Strategy to Promote Health Care Professional Well-Being.

PURPOSE: A growing waitlist for Mindfulness in Motion (MIM), an evidence-based worksite mindfulness-based intervention, necessitated a training system with built in fidelity assurance to meet program demand. MIM was delivered as part of an organizational strategy in a large academic health center to enhance Health Care Professional (HCP) well-being. In order to ensure that the intervention was being delivered the same way to each cohort, a process to ensure intervention fidelity was developed for MIM. METHOD: The core components of MIM informed the development of a detailed fidelity monitoring system to ensure consistent intervention delivery. Each MIM cohort was conducted with both trained facilitators and trained intervention fidelity monitors. RESULTS: Across 11 cohort offerings of MIM, each 8 weeks in length, there was a mean adherence rate of 0.9886, SD = 0.0012. CONCLUSION: The fidelity monitoring system allowed for a reliable expansion of MIM offerings to HCPs and for a seamless pivot to fully virtual MIM delivery, necessitated by COVID-19.