Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

Abstract

IntroductionMild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.Methods and analysisA family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.Ethics and disseminationThe CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.Trial registration numberNCT04254302.

The Development and Pilot Testing of a Fidelity Checklist for a Family-Centered Telehealth Intervention for Parents of Children with Motor Delay

“…The process of identifying key components of the WECARE intervention was informed by the theory of change supporting the WECARE intervention ( Camden et al, 2021 ; Hurtubise et al, 2022 ), the Paediatric Rehabilitation Observational Measure of Fidelity (PROF) parent and therapist-parent behaviors ( DiRezze et al, 2013 ), the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-O) observational measure of therapists, parent, and therapist-parent interaction behaviors ( King et al, 2019 ), and the Occupational-Performance Fidelity Measure (OPC-FM) ( Graham et al, 2020 ). These key intervention components created the foundation for the WECARE Fidelity Checklist (see Figure 2 for these components).…”

“…This study was nested within the context of the WECARE family-centered pragmatic randomized control trial ( Camden et al, 2021 ). It used a multi-methods approach.…”

“…Because rehabilitation is a dynamic and interactive process, many interventions will have common components ( An et al, 2021 ). Based on the theory of change supporting the WECARE intervention ( Camden et al, 2021 ; Hurtubise et al, 2022 ), this exploratory step was comprised of (a) a scan of the literature, and (b) validation of the components by experts' opinion. The rapid scan examined empirical evidence related to coaching interventions used in pediatric rehabilitation ( Akhbari Ziegler & Hadders-Algra, 2020 ; Baldwin et al, 2013 ; Dunn et al, 2018 ; Little, Pope, et al, 2018 ; Ogourtsova, O'Donnell, et al, 2019 ; Ogourtsova, O'Donnell, et al, 2019 ; Schwellnus et al, 2015 ), pediatric telehealth ( Camden et al, 2020 ; Camden & Silva, 2021 ; Cason et al, 2012 ; Little et al, 2018 ; McCarthy & Guerin, 2021 ; Olsen et al, 2012 ), family-centered care practices ( An & Palisano, 2014 ; Bamm & Rosenbaum, 2008 ; King, 2014 ; King et al, 2017 ; Law et al, 2003 ), parent engagement ( King et al, 2019 ; King et al, 2014 ), and measures related to parent engagement, and generic and coaching specific intervention fidelity in pediatric rehabilitation ( Dunn et al, 2018 ; Graham et al, 2020 ; King et al, 2019 ; DiRezze et al, 2013 ).…”

“…In the case of this study, the new intervention was the Web-based Early intervention for Children with motor difficulties using multimodAl REhabilitation ( WECARE ) intervention. The WECARE intervention was developed for a family-centered pragmatic randomized control trial (NCT04254302) comparing its effectiveness to usual care on the functional abilities of children (aged 3-8 years) with motor difficulties and their parents' knowledge, skills and health-related quality of life ( Camden et al, 2021 ). The intervention was created based on the findings of previous pilot and feasibility studies, a systematic review of pediatric rehabilitation telehealth interventions, and consultations with parents, clinicians, and other interested parties (e.g., managers, technicians) who may be involved in such an intervention ( Camden et al, 2019 ; Camden et al, 2020 ; Hurtubise et al, 2022 ; Pratte, 2018 ).…”

Training Intervention and Program of Support for Fostering the Adoption of Family-Centered Telehealth in Pediatric Rehabilitation: Protocol for a Multimethod, Prospective, Hybrid Type 3 Implementation-Effectiveness Study

“…To monitor therapist fidelity to FCT practices (ie, objective 1b), the FCT fidelity self-perceived checklist and Pediatric Rehabilitation Intervention Measure of Engagement-Service Provider version (PRIME-SP) will be used. The FCT fidelity self-perceived checklist , a 4-item instrument, developed and pilot tested in a previous study [ 84 ], will measure therapists’ perceptions of the perceived quality of 3 interventional behaviors associated with the FCT clinical intervention (ie, goal focused, active parent partnerships, and evidence of supportive and trusting parent-professional relationships) based on their last telehealth session. Each behavior, comprising 4 criteria, is scored on a 5-point Likert scale (0=behavior not implemented when it should have been to 4=all the identified behaviors were implemented when appropriate and within context).…”