Clinical trial NCT03880383: BRIGHT Coaching Program for Families
Official title: BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Parent-Child Relations
Child Developmental Delay
Parenting
Parent-child Problem
Child Development Disorder
Autism Spectrum Disorder
Keywords: brain-based developmental disorders
child development
preschool skills and development
parenting stress
parenting mental health
coaching intervention
online education
parent peer support
developmental delay
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of Alberta
First posted: 2019-03-19
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual and locally available care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The control group will be provided with partial intervention at the end of the 18 month study. The target population for this novel service delivery model is families with children aged 1.5 to 4.5 years old with developmental concerns, who are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Children with, or at elevated risk for, brain-based developmental disabilities can experience lifelong consequences and challenges throughout their development. In particular, preschool years (3-6 years of age) can be stressful as families wait to get services and care for their child. Nationally and internationally, service delivery models during this critical period are not standardized, and differ within and across provinces and across patient conditions, leading to long wait times, service gaps and duplications.

This study has two main hypotheses:

1. A standardized approach to "coaching" (i.e. coach + online education tools + peer support network) is feasible in the real-life context, and acceptable to caregivers and can be delivered across multiple sites in urban/suburban/rural settings.
2. A standardized approach to "coaching" enhances parental health (parents' empowerment and sense of competence, quality of life, and minimizes parenting stress), family health care experience (care coordination experience and process of care) at similar health care cost (economic analysis), when compared to usual and locally available care.

Detailed description: Rationale:

Children with, or at elevated risk for, brain-based developmental disabilities experience chronic lifelong functional consequences with new challenges emerging at each stage of development. In the preschool years (3-6 years), needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioural and social skills. The preschool years are a time of stress for families as young child awaits assessment, or even as they receive services for brain-based disorders. Similarly, the system and society struggle to meet needs of families in a timely and appropriate manner in the face of escalating costs. Given these struggles, there is a need to examine whether a health-coach style of intervention coupled with parent education delivered through an online platform can be effective in empowering families, by delivering information, providing social (parent to parent) supports, and decreasing demand on health and developmental services. This innovation provides a significant service re-design in a system at critical point of transition.

Study objective:

To evaluate the feasibility and the effectiveness (changes in parent health, developmental service utilization and cost effectiveness) of a self-management intervention (including developmental coach, online education tools and support network), when compared to usual and locally available care in service delivery practices, for parents of preschool children with suspected developmental delays.

Methodology / Study design:

This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The target population for this novel service delivery model is children aged 1.5 to 4.5 years old who are at a high risk for or suspected of having developmental delays, that are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural). In the first year, a technology-supported health coach service delivery model will be developed in conjunction with families. A feasibility/acceptability pilot study was conducted to ensure that the intervention is feasible in the real life context across 4 participating Canadian provinces.

Participants:

Eligible children and their families will be recruited to include children who are 1.5 to 4.5 years at the age at enrolment. Children will be living in four diverse parts of Canada to ensure national representation and future scalability: Vancouver; Winnipeg; Montreal and Halifax. Participants' postal codes will be analyzed to ensure representation: rural/remote, small urban and large urban/metro representation with purposeful sampling as required. From the patient population perspective, two different groups that are likely to manifest new global developmental delays at this stage will be recruited. They are at high risk for brain-based developmental delays, however some will have no delay and others will have mild, moderate or severe delays.

Study procedures: Intervention and control Recruitment begins with family contact. Families are contacted via the centre to which they were referred for developmental diagnosis and assessment. A member of the clinical team will ask if they are interested to learn more about the BRIGHT Coaching study. If interested, the families' contact information will be shared with the local research assistant (RA) overseeing the trial. The RA will speak to a parent by phone and follow up with an introductory letter by mail explaining the procedures of the study, together with the consent form and a self-addressed stamped envelope to return to the RA if interested in participating. After 2 weeks, if no consent form is received, the RA will call the family once again to determine their interest in participating. Once consent is signed, participants will conduct baseline assessments including documentation of their care and social networks, and be randomized using a computer-generated algorithm; randomization will be stratified by site. The allocation ratio for intervention or control will be 1:1 for each site.

Eligibility criteria: Children are beginning to manifest delays in one or more domains of development, and they have been newly referred to a service to get assessed, diagnosed, and/ or for therapeutic intervention. Their families are thus in the early stages of their journey of getting assessment, diagnosis and/or intervention.

Inclusion Criteria:

* Children between the ages of 1.5 years to 4.5 years at enrolment;
* Suspected or confirmed delays in one or more developmental domains (such as motor, cognitive, speech, social and/or behavioural).
* Has been newly referred to a given service agency/program for assessment and/or intervention services (some services may have been provided in the past in infancy)
* Willing to participate in the study for 3 assessments: at enrolment; 8 months later, and 12 months later.

Exclusion Criteria:

* Non-English or non-French speaking;
* Unwilling or unable to participate in intermittent assessments (by phone or in-person).
* Do not have access on a routine basis to the internet through a desktop, laptop or mobile.

Primary outcomes:
measure: Family Empowerment Scale (FES) - change is being assessed.
timeFrame: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
measure: Parent Sense of Competency (PSOC) Scale - change is being assessed.
timeFrame: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Secondary outcomes:
measure: 36-Item Short Form Survey (SF-36) - change is being assessed.
timeFrame: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
measure: Parenting Stress Index - 36 (PSI-36) - change is being assessed.
timeFrame: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
measure: Measure of Process of Care - 20 (MPOC - 20) - change is being assessed.
timeFrame: 10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
measure: Resource Utilization Questionnaire - Preschoolers (RUQ-P) - change is being assessed.
timeFrame: 45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Other outcomes:
measure: Vineland Adaptive Behavior Scales (Vineland)
timeFrame: 20-60 minutes, at baseline visit only.
measure: Readiness to receive coaching
timeFrame: 5 minutes, at baseline visit only.
measure: Demographic form
timeFrame: 10-15 minutes, at baseline visit only.
Locations:
city: Vancouver
country: Canada
facility: Child Health BC, BC Children's Hospital, UBC
state: British Columbia
city: Winnipeg
country: Canada
facility: Specialized Services for Children and Youth (SSCY) Centre
state: Manitoba
city: Halifax
country: Canada
facility: Izaak Walton Killam (IWK) Health Centre
state: Nova Scotia
city: Montréal
country: Canada
facility: Research Institute of McGill University Health Centre, Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: Research Institute of McGill University Health Centre
name: Annette Majnemer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Provincial Health Services Authority
name: Maureen O'Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Mar;40(3):197-204. doi: 10.1016/j.pediatrneurol.2008.09.014.
citation: Vohr B. Long-term outcomes of moderately preterm, late preterm, and early term infants. Clin Perinatol. 2013 Dec;40(4):739-51. doi: 10.1016/j.clp.2013.07.006. Epub 2013 Sep 20.
citation: Mazer, B., Majnemer, A., and Shevell M., Service utilization and health promotion of children with neuro-developmental disabilities. Neurodevelopmental disabilities: Clinical and scientific foundation, 2009: p. p. 426-441.
citation: Grilli L, Feldman DE, Swaine B, Gosselin J, Champagne F, Pineault R. Wait times for paediatric rehabilitation. Healthc Policy. 2007 Feb;2(3):e171-87.
citation: 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 Dec 21;9:242. doi: 10.1186/1472-6963-9-242.
citation: Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
citation: Leahey TM, Wing RR. A randomized controlled pilot study testing three types of health coaches for obesity treatment: Professional, peer, and mentor. Obesity (Silver Spring). 2013 May;21(5):928-34. doi: 10.1002/oby.20271.
citation: Huffman MH. HEALTH COACHING: a fresh, new approach to improve quality outcomes and compliance for patients with chronic conditions. Home Healthc Nurse. 2009 Sep;27(8):490-6; quiz 496-8. doi: 10.1097/01.NHH.0000360924.64474.04.
citation: Kiresuk, T.J., Smith A., and Cardillo J.E. , Goal attainment scaling: Applications, theory, and measurement. Psychology Press, 2014.
citation: Ottenbacher KJ, Msall ME, Lyon N. Measuring developmental and functional status in children with disabilities. Pediatr Phys Ther. 2000 Winter;12(4):198-9. No abstract available.
citation: Abidin, R.R., PARENTING STRESS INDEX (4th ed.). 2012: Lutz, FL: PAR.
citation: Koren PE, D.N., Friesen BJ. , Measuring empowerment in families whose children have emotional disabilities: a brief questionnaire. Rehabilitation Psychology, 1992. 37(4): p. 305.
citation: Ohan JL, L.D., Johnston C., The Parenting Sense of Competence scale: Evidence of a stable factor structure and validity. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 2000 Oct. 32(4): p. 251.
citation: Ware JE, S.K., Kosinski M, Gandek B, SF-36 HEALTH SURVEY MANUAL AND INTERPRETATION GUIDE, M.T.H.I. Boston, New England Medical Center, Editor. 1993.
citation: 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 Mar;32(2):167-76. doi: 10.1111/j.1365-2214.2006.00604.x.
citation: Borgatti SP, E.M., Freeman LC, Ucinet for Windows: Software for Social Network Analysis, M.H.-A.T. Cambridge, Editor. 2002.
citation: 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 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
citation: Katz P, Morris A, Trupin L, Yazdany J, Yelin E. Disability in valued life activities among individuals with systemic lupus erythematosus. Arthritis Rheum. 2008 Apr 15;59(4):465-73. doi: 10.1002/art.23536.
citation: Majnemer A, O'Donnell M, Ogourtsova T, Kasaai B, Ballantyne M, Cohen E, Collet JP, Dewan T, Elsabbagh M, Hanlon-Dearman A, Filliter JH, Lach L, McElroy T, McGrath P, McKellin W, Miller A, Patel H, Rempel G, Shevell M, Wittmeier K; Parent-Panel. BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay. Front Pediatr. 2019 Aug 7;7:332. doi: 10.3389/fped.2019.00332. eCollection 2019.