BRIGHT Coaching Program for Families (NCT03880383) | Clinical Trial Compass
CompletedNot Applicable
BRIGHT Coaching Program for Families
Canada306 participantsStarted 2018-08-23
Plain-language 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.
Who can participate
Age range
18 Months – 54 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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])
2
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])
Trial details
NCT IDNCT03880383
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre