Abstract
Background: In preschool-aged children with, or at elevated risk for, developmental disabilities, challenges and needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills. For families, this can be a stressful period as they witness the gradual unfolding of their child's differences and await to receive care. Nationally and internationally, service delivery models during this critical period are not standardized nor are they nimble or sufficient enough, leading to long wait times, service gaps and duplications. Given these struggles, there is a need to examine whether “health coaching”, a structured educational program that is deliverable by different and more accessible means, can be effective in empowering families, by delivering information, providing social supports, and decreasing the demands on the overwhelmed health and developmental services. The primary objective is to evaluate the feasibility and the effectiveness of a coaching intervention (in comparison to usual and locally available care), for parents of children with emerging developmental delays.Method/Design: A multi-centered pragmatic randomized controlled trial design will be used. Families will be recruited from a representative sample of those awaiting publicly-funded regional child health services for children with developmental delays in four Canadian provinces. The target sample size is 392 families with children aged 1.5 to 4.5 years at recruitment date. Families will be randomly assigned to receive either the BRIGHT Coaching intervention (coach supported, hardcopy and online self-managed educational resources: 14 sessions, 2 sessions every 4 weeks for 6–9 months) or usual care that is locally available. In addition to the feasibility and acceptability measures, outcomes related to family empowerment, parental satisfaction and efficacy with caregiver competency will be evaluated at baseline, post-treatment (8 months), and follow-up (12 months).Discussion: This manuscript presents the background information, design, description of the interventions and of the protocol for the randomized controlled trial on the effectiveness of BRIGHT Coaching intervention for families of children with emerging developmental delays.Trial Registration: ClinicalTrials.gov, U.S. National Library of Medicine, National Institutes of Health #NCT03880383, 03/15/2019. Retrospectively registered.
Highlights
In preschool-aged children with, or at elevated risk for, developmental disabilities, challenges and needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills
Developmental disabilities, resulting from disorders of the developing nervous system, include limitations in function that begin to manifest during infancy or childhood as delays in reaching developmental milestones or as lack of function in one or multiple areas of cognition, motor performance, vision, hearing and speech, and behavior [1]
In the preschool years (3–6 years), needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills [2, 3]
Summary
In preschool-aged children with, or at elevated risk for, developmental disabilities, challenges and needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills This can be a stressful period as they witness the gradual unfolding of their child’s differences and await to receive care. In the preschool years (3–6 years), needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioral, and social skills [2, 3] This can be a stressful period as they witness their child’s differences and await assistance to organize health and educational services and receive relevant and appropriate care (i.e., diagnosis and therapeutic interventions) and they must consider the best options in preparation for optimal school entry. Science has emerged demonstrating how patient education programs that promote self-management for those with specific chronic conditions improve health behaviors, enhance health status, and Abbreviations: ANOVA, Analysis of variance; BC, British Columbia; CIHR, Canadian Institutes of Health Research; KT, Knowledge translation; MCID, minimal clinically important difference; MUHC, McGill University Health Centre; RA, Research assistant; RCT, Randomized Clinical Trial; RI, Research Institute; SAS, Statistical Analysis System; SD, Standard deviation; SPOR, Strategies for Patient Oriented Research; UBC, University of British Columbia
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