A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol

Abstract

Background Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to therapy, and service delivery efficiency. The primary objective of this trial is to determine the effectiveness of a principles-driven, child-focused approach to goal-setting, Enhancing Child Engagement in Goal-Setting (ENGAGE), on pediatric rehabilitation outcomes compared to usual practice. The three secondary objectives are to 1) compare costs and secondary outcomes of the ENGAGE approach to usual practice, 2) determine the influence of child, parent and therapist characteristics on child engagement in therapy and rehabilitation outcomes, and 3) identify barriers and facilitators to the implementation of ENGAGE. Methods This research protocol describes a pragmatic, multi-site, cluster, effectiveness-implementation (hybrid type 1 design) randomized controlled trial. Therapists (n = 12 clusters of two therapists) at participating sites (n = 6) will be randomized to 1) the ENGAGE intervention group, or 2) usual care (control) using a computer-generated, permuted-block randomization sequence with site as a stratification variable designed by a statistician (RR). Each therapist will recruit four children 5–12 years old with neurodevelopmental conditions (n = 96), who will receive ENGAGE or usual care, according to therapist group allocation. ENGAGE therapists will be trained to use a 'toolbox' of evidence-driven, theory-informed principles to optimize child and parent motivation, engagement in the goal-setting process, and performance feedback strategies. Outcomes include goal performance (primary outcome), engagement in therapy, functional abilities, participation, and parent and child quality of life. Qualitative interviews with children, parents, ENGAGE therapists, and managers will explore challenges to implementation and potential mitigation strategies. Mixed effects multiple linear regression models will be developed for each outcome to assess group differences adjusted for clustering. A cost-effectiveness analysis will combine cost and a measure of effectiveness into an incremental cost-effectiveness ratio. Qualitative data on implementation will be analyzed inductively (thematic analysis) and deductively using established implementation science frameworks. Discussion This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal-setting practices. Trial Registration NCT05017363 (registered August 23, 2021 on ClinicalTrials.gov).

Use of Goal Attainment Scaling to Measure Educational and Rehabilitation Improvements in Children with Multiple Disabilities

“…Knowing that pain can negatively impact QOL, it should also be noted that reported pain severity values for CMD that attended PACE were reduced. The values of 2.92 and 2.15 for the 2010-2011 and 2011-2012 years, respectively, are lower than those reported for similar children [43,44].…”

Development and validation of the activities and participation children and adolescents –neck (APCAN) measure

“…Finally, while using parent reported measures, it is observed that parents may either overestimate or underestimate the impact of pain in children due to the parent’s personal characteristics and contextual factors [ 55 ]. This may lead to a mismatch between the clinician’s, child’s, and parent’s perspective on creating meaningful and appropriate goals [ 55 , 56 ]. Given that children above the age of 8 can reliably use self-report measures, [ 17 , 42 ].…”

“…9, 11,14 and 17). The inclusion of activities specifically selected by children provides a strong framework for creating collaborative goal setting between the child, rehabilitation professional, family, and other professionals thereby facilitating family-centered care [ 56 , 58 ].…”

Title: Development and Content Validation of the Pediatric Dizziness Index (PDI)

“…For this purpose, creating goals that are valued by the child and are considered meaningful is critical to obtain improvements in function. [42][43][44] In contrast to PVSQ and DHI-PC, Item 7 of the PDI provides an opportunity to children to identify their activity of choice.…”