BRIGHT Coaching Program for Families

NCT03880383 | Completed DMC

• 1 other identifier: 2017-3159
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 4

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. 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• Family Empowerment Scale (FES) - change is being assessed.

  The FES is composed of 34 statements that describe how a parent or caregiver of a child with an emotional, behavioral and/or developmental challenges may feel about his or her situation (i.e. sense of empowerment). For each statement, the participant is asked to circle the response that best describes how the statement applies to him/her. The scale ranges from 1 (Not True at All) to 5 (Very True), for a maximum of 170 points and a minimum of 34 points. A higher score represent a higher sense of empowerment (i.e. better outcome).

  10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

• Parent Sense of Competency (PSOC) Scale - change is being assessed.

  The PSOC measures parents' sense of competence and is a 17-item scale, with 2 subscales. Each item is rated on a 6-point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". A higher score indicates a higher parenting sense of competency.

  10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

Secondary Outcomes (4)

• 36-Item Short Form Survey (SF-36) - change is being assessed.

  7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

• Parenting Stress Index - 36 (PSI-36) - change is being assessed.

  7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

• Measure of Process of Care - 20 (MPOC - 20) - change is being assessed.

  10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

• Resource Utilization Questionnaire - Preschoolers (RUQ-P) - change is being assessed.

  45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])

Other Outcomes (3)

• Vineland Adaptive Behavior Scales (Vineland)

  20-60 minutes, at baseline visit only.

• Readiness to receive coaching

  5 minutes, at baseline visit only.

• Demographic form

  10-15 minutes, at baseline visit only.

Study Arms (2)

Group 1 - Coaching

EXPERIMENTAL

Upon enrollment to the study, parents in this group will have immediate access to the full intervention: * Coaching: Telephone contact with coaches, who will provide information, education and support about the child's development. Coaching will be adapted to family needs, situation, preferences and child's condition. * Online parent education: Parents will be provided access to empowering online tools, such as educational resources, chosen or developed by other parents and researchers. * Peer support tools: Parents will have access to a secure online social media tool to connect to other parents going through a similar experience. Through this tool, parents can help support each other, and share their experiences and knowledge.

Behavioral: Coaching; Behavioral: Online parent education; Behavioral: Online peer support

Group 2- Partial and delayed coaching

OTHER

Parents in this group will have delayed and partial access to coaching, at the end of the 18-month period. Parents in this group will have a one-time session with a developmental coach who can give them guidance about their child's development. Parents in this group will also then get access to online parent education and peer support tools, indefinitely, until the online platform is de-activated. \* Both arms/groups\* will obtain usual care for their child, in addition and independent of full or partial coaching.

Behavioral: Online parent education; Behavioral: Online peer support

Interventions

Coaching BEHAVIORAL

Parents will interact and communicate regularly with a coach in person or by telephone. Coaches will be responsible for: identifying developmental concerns, proactive health promotion, guidance and training for developmental stimulation, parent support and education about child development, navigation of the health care system and self-management techniques. The frequency of coaching will be: once a month (minimum), for 18 months, at an average of 2.5 hours per month.

Also known as: coaching, family support

Group 1 - Coaching

Online parent education BEHAVIORAL

Parents will be provided access to an online platform which will provide educational resources and access to parent-parent support. Online resources on child development are curated by researchers and representative of parent groups, and linked to this online platform. The themes covered in the online tool include resources on child development, accessing health care services and managing emotions and family dynamics. These topics range from: practical tips for managing day-to-day challenges, strategies to cope and support the child's transitions from one stage to another, practical tips when looking for developmental services for the child: knowing where and how to access services.

Also known as: educational resources

Group 1 - Coaching; Group 2- Partial and delayed coaching

Online peer support BEHAVIORAL

Parents will have access to a secure online social media tool to connect to other parents going through a similar experience. Through this tool, parents can help support each other, and share their experiences and knowledge. This will put each family at the centre of each network (family, friends, health providers), allowing family networks to link with one another. Families will be able to find resources, create connections with the coach, health providers and other families, thus creating a network to support one another.

Also known as: parent support, patient support, sharing experiences

Group 1 - Coaching; Group 2- Partial and delayed coaching

Eligibility Criteria

• Age: 18 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Alberta: collaborator

Study Sites (4)

Child Health BC, BC Children's Hospital, UBC

Vancouver, British Columbia, V5Z 2X8, Canada

Location

Specialized Services for Children and Youth (SSCY) Centre

Winnipeg, Manitoba, R3E 3G1, Canada

Location

Izaak Walton Killam (IWK) Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Research Institute of McGill University Health Centre, Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (19)

• 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.

  PMID: 19218033 BACKGROUND

• 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.

  PMID: 24182959 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19305712 BACKGROUND

• 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.

  PMID: 20025770 BACKGROUND

• 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.

  PMID: 10413387 BACKGROUND

• 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.

  PMID: 23784896 BACKGROUND

• 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.

  PMID: 19745624 BACKGROUND

• Kiresuk, T.J., Smith A., and Cardillo J.E. , Goal attainment scaling: Applications, theory, and measurement. Psychology Press, 2014.

  BACKGROUND

• 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.

  PMID: 17091034 BACKGROUND

• Abidin, R.R., PARENTING STRESS INDEX (4th ed.). 2012: Lutz, FL: PAR.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16441851 BACKGROUND

• Borgatti SP, E.M., Freeman LC, Ucinet for Windows: Software for Social Network Analysis, M.H.-A.T. Cambridge, Editor. 2002.

  BACKGROUND

• 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.

  PMID: 12719681 BACKGROUND

• 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.

  PMID: 18383406 BACKGROUND

• 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.

  PMID: 31440489 DERIVED

MeSH Terms

Conditions

Learning Disabilities; Developmental Disabilities; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Study Officials

• Annette Majnemer, PhD

  Research Institute of McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Maureen O'Donnell, MD

  Provincial Health Services Authority British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the context of the provided intervention (coaching vs. usual and locally available care) and outcome measures used (self-reported),blinding of participants, care providers, investigators nor that of the assessor is possible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - School of Physical & Occupational Therapy. Vice Dean - Education, Faculty of Medicine

Model Details: 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).

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 19, 2019
• Study Start: August 23, 2018
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)