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NCT03880383
BRIGHT Coaching Program for Families
NA trial testing Coaching in Mental Health Wellness 1 in 306 participants. Completed in 31 March 2023.
30 September 2022
Quick facts
| Lead sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 306 |
| Start date | 23 August 2018 |
| Primary completion | 30 September 2022 |
| Estimated completion | 31 March 2023 |
| Sites | 4 locations across Canada |
Drugs / interventions tested
- Coaching
- Online parent education
- Online peer support
Conditions studied
- Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →
- Parent-Child Relations — all drugs for Parent-Child Relations →
- Child Developmental Delay — all drugs for Child Developmental Delay →
- Parenting — all drugs for Parenting →
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Who can join
Adults 18 Months to 54 Months, any sex, with Mental Health Wellness 1 or Parent-Child Relations. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay.
Majnemer A, O'Donnell M, Ogourtsova T, Kasaai B, et al · · 2019 · cited 9× · PMID 31440489 · DOI 10.3389/fped.2019.00332 -
Parent coaching program for children with emerging developmental disabilities while on a waitlist for services: cost analysis from a family payer perspective.
Jia XY, Moretti ME, Ungar WJ, Wittmeier K, et al · · 2026 · PMID 41795079 · DOI 10.1186/s12887-026-06610-2
Verify or expand the search:
- PubMed search for NCT03880383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03880383 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03880383.
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