BRIGHT Coaching Program for Developmental Disabilities

Recruiting at 3 trial locations

Overseen By Hana MacDougall, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Non-English/French, No internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

306 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Annette Majnemer, PhD

Principal Investigator

Research Institute of McGill University Health Centre

Maureen O'Donnell, MD

Principal Investigator

Provincial Health Services Authority

Eligibility Criteria

This trial is for families with children aged 1.5 to 4.5 years who are suspected of or confirmed to have developmental delays and are new to a service agency for assessment/intervention. Participants must be able to complete three assessments over a year and speak English or French.

Inclusion Criteria

You have difficulties or delays in one or more areas of development, such as movement, thinking, speaking, socializing, or behavior.

Willing to participate in the study for 3 assessments: at enrolment; 8 months later, and 12 months later.

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)

Exclusion Criteria

Do not have access on a routine basis to the internet through a desktop, laptop or mobile.

I am willing and able to participate in check-ups, whether by phone or in person.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including documentation of care and social networks, and randomization

1-2 weeks

1 visit (in-person or virtual)

Intervention

Participants receive coaching, online education tools, and peer support network

8 months

Regular virtual check-ins

Follow-up

Participants are monitored for changes in parent health, developmental service utilization, and cost effectiveness

4 months

3 visits (virtual)

Open-label extension (optional)

Participants may continue to access online parent education and peer support tools

Indefinite

Treatment Details

Interventions

• BRIGHT Coaching Program

Trial Overview The study tests if a standardized coaching program, which includes a coach, online education tools, and peer support network, can improve parental health, family healthcare experience, and be cost-effective compared to usual care.

Participant Groups

Group I: Group 2- Partial and delayed coaching Experimental Treatment 2 Interventions

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.

Group II: Group 1 - Coaching Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+