BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay

Annette Majnemer, Maureen O'Donnell, Tatiana Ogourtsova, Bahar Kasaai, Marilyn Ballantyne, Eyal Cohen, Jean-Paul Collet, Tammie Dewan, Mayada Elsabbagh, Ana Hanlon-Dearman, Jillian Helen Filliter, Lucyna Lach, Theresa McElroy, Patrick McGrath, William McKellin, Anton Miller, Hema Patel, Gina Rempel, Michael Shevell, Kristy Wittmeier, Parent-Panel, Annette Majnemer, Maureen O'Donnell, Tatiana Ogourtsova, Bahar Kasaai, Marilyn Ballantyne, Eyal Cohen, Jean-Paul Collet, Tammie Dewan, Mayada Elsabbagh, Ana Hanlon-Dearman, Jillian Helen Filliter, Lucyna Lach, Theresa McElroy, Patrick McGrath, William McKellin, Anton Miller, Hema Patel, Gina Rempel, Michael Shevell, Kristy Wittmeier, Parent-Panel

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.

Keywords: childhood disability; coaching; developmental delay; family; health coaching; parents.

Figures

Figure 1
Figure 1
Prevalence of responses for each component within 3 topic areas.
Figure 2
Figure 2
BRIGHT coaching topics and themes.

References

    1. Institute_of_Medicine PART II: developmental disabilities In: Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenge in the Developing World (Washington, DC: ) (2001).
    1. Majnemer A, Limperopoulos C, Shevell MI, Rohlicek C, Rosenblatt B, Tchervenkov C. A new look at outcomes of infants with congenital heart disease. Pediatr Neurol. (2009) 40:197–204. 10.1016/j.pediatrneurol.2008.09.014
    1. Vohr B. Long-term outcomes of moderately preterm, late preterm, and early term infants. Clin Perinatol. (2013) 40:739–51. 10.1016/j.clp.2013.07.006
    1. Mazer B, Majnemer A. Service utilization and health promotion of children with neurodevelopmental disabilities. In: Shevell M, editor. Neurodevelopmental Disabilities: Clinical and Scientific Foundations, International Review of Child Neurology Series. London: MacKeith Press; (2009). p. 426–41.
    1. Majnemer A, Shevell MI, Rosenbaum P, Abrahamowicz M. Early rehabilitation service utilization patterns in young children with developmental delays. Child Care Health Dev. (2002) 28:29–37. 10.1046/j.1365-2214.2002.00237.x
    1. Grilli L, Feldman DE, Swaine B, Gosselin J, Champagne F, Pineault R. Wait times for paediatric rehabilitation. Health Care Policy. (2007) 2:e171–187. 10.12927/hcpol.2007.18681
    1. Miller AR, Condin CJ, McKellin WH, Shaw N, Klassen AF, Sheps S. Continuity of care for children with complex chronic health conditions: parents' perspectives. BMC Health Serv Res. (2009) 9:242 10.1186/1472-6963-9-242
    1. Lorig K, Sobel DS, Stewart A, Brown B, Bandura A, Ritter P, et al. . Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization, a randomized trial. Med Care. (1999) 37:5–14. 10.1097/00005650-199901000-00003
    1. Leahey TM, Wing RR. A randomized controlled pilot study testing three types of health coaches for obesity treatment: professional, peer, and mentor. Obesity. (2013) 21:928–34. 10.1002/oby.20271
    1. Huffman MH. HEALTH COACHING: a fresh, new approach to improve quality outcomes and compliance for patients with chronic conditions. Home Healthc Nurse. (2009) 27:490–6 10.1097/01.NHH.0000360924.64474.04
    1. Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. (2007) 39:175–91. 10.3758/BF03193146
    1. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. (2003) 41:582–92. 10.1097/01.MLR.0000062554.74615.4C
    1. Katz P, Morris A, Trupin L, Yazdany J, Yelin E. Disability in valued life activities among individuals with systemic lupus erythematosus. Arthritis Rheum. (2008) 59:465–73. 10.1002/art.23536
    1. Ottenbacher KJ, Msall ME, Lyon N. Measuring developmental and functional status in children with disabilities. Pediatr Phys Ther. (2000) 12:198–9. 10.1097/00001577-200001240-00011
    1. Abidin R R. (2012). Parenting Stress Index, 4th Edn. Lutz, FL: PAR.
    1. Koren PE, Neal D, Friesen BJ. Measuring empowerment in families whose children have emotional disabilities: a brief questionnaire. Rehabil Psychol. (1992) 37:305 10.1037/h0079106
    1. Singh NN, John Curtis W, Ellis CR, Nicholson MW, Villani TM, Wechsler HA. Psychometric analysis of the family empowerment scale. J Emot Behav Disord. (1995) 3:85–91. 10.1177/106342669500300203
    1. Ohan JL, Leung DW, Johnston C. The Parenting sense of competence scale: evidence of a stable factor structure and validity. Can J Behav Sci. (2000) 32:251 10.1037/h0087122
    1. Ware JE, Snow K, Kosinski M, Gandek B. SF-36 Health Survey Manual And Interpretation Guide. Boston: New England Medical Center, MTHI; (1993)
    1. Dyke P, Buttigieg P, Blackmore AM, Ghose A. Use of the measure of process of care for families (MPOC-56) and service providers (MPOC-SP) to evaluate family-centred services in a paediatric disability setting. Child Care Health Dev. (2006) 32:167–76. 10.1111/j.1365-2214.2006.00604.x
    1. Ungar WJ, Tsiplova K, Millar N, Smith IM. Development of the Resource Use Questionnaire (RUQ-P) for families with preschool children with neurodevelopmental disorders: Validation in children with autism spectrum disorder. Clin Pract Pediatric Psychol. (2018) 6:164–78. 10.1037/cpp0000226
    1. Sparrow SS, Cicchetti DV, Balla DA. Vineland-II Adaptive Behavior Scales: Survey Forms Manual. Circle Pines, MN: AGS Publishing; (2005).
    1. Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika. (1965) 52:591–611. 10.1093/biomet/52.3-4.591
    1. Levene H. Robust Tests for Equality of Variances. Palo Alto, CA: Stanford University Press; (1960).
    1. Fisher Box J. Guinness, gosset, fisher, and small samples. Stat Sci. (1987) 2:45–52. 10.1214/ss/1177013437
    1. Corder GW, Foreman DI. Nonparametric Statistics: A Step-by-Step Approach. Hoboken, NJ: John Wiley & Sons, Inc; (2014).
    1. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics. (1997) 53:983–97. 10.2307/2533558
    1. Borgatti SP, Everett MG, Freeman LC. Ucinet for Windows: Software for Social Network Analysis. Cambridge, MA: Harvard-Analytic Technologies; (2002).
    1. Carter N, Bryant-Lukosius D, DiCenso A, Blythe J, Neville AJ. The use of triangulation in qualitative research. Oncol Nurs Forum. (2014) 41:545–7. 10.1188/14.ONF.545-547
    1. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. (2005) 15:1277–88. 10.1177/1049732305276687
    1. Ogourtsova T, O'Donnell M, Majnemer A. Coach, care coordinator, navigator or keyworker? review of emergent terms in childhood disability. Phys Occup Ther Pediatr. (2019) 39:119–23. 10.1080/01942638.2018.1521891
    1. Ogourtsova T, O'Donnell M, Souza Silva W, Majnemer A. Health coaching for parents of children with developmental disabilities: systematic literature review. Dev Med Child Neurol. (2019). 10.1111/dmcn.14206. [Epub ahead of print].
    1. Research C.I. o. H Canada's Strategy for Patient-Oriented Research: Improving Health Outcomes Through Evidence-Informed Care. Ottawa, ON: (2011).

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever