← Back to Search

BRIGHT Coaching Program for Developmental Disabilities

N/A

Waitlist Available

Led By Annette Majnemer, PhD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children between the ages of 1.5 years to 4.5 years at enrolment

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test whether a standardized coaching program can help families of children with developmental disabilities across multiple sites in different settings.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like coaching and online support rather than drugs or medical procedures, traditional side effects aren't expected; however participants may experience emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 1.5 and 4.5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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

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

+1 more

Other outcome measures

Demographic form

Readiness to receive coaching

Vineland Adaptive Behavior Scales (Vineland)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2- Partial and delayed coachingExperimental Treatment2 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 - CoachingExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Coaching

2016

Completed Phase 3

~5600

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

442 Previous Clinical Trials

158,824 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,340 Previous Clinical Trials

26,452,348 Total Patients Enrolled

University of AlbertaOTHER

886 Previous Clinical Trials

384,428 Total Patients Enrolled

Media Library

BRIGHT Coaching Program Clinical Trial Eligibility Overview. Trial Name: NCT03880383 — N/A

Child Developmental Delay Research Study Groups: Group 2- Partial and delayed coaching, Group 1 - Coaching

Child Developmental Delay Clinical Trial 2023: BRIGHT Coaching Program Highlights & Side Effects. Trial Name: NCT03880383 — N/A

BRIGHT Coaching Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03880383 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of this research project?

"The primary assessment for this trial is the Family Empowerment Scale (FES) - change, and secondary assessments include Resource Utilization Questionnaire-Preschoolers (RUQ-P), Parenting Stress Index 36 (PSI-36), and 36 Item Short Form Survey (SF-36). These metrics will be assessed through multiple choice responses over a period of 10 to 15 minutes at baseline, 8 months post entry, and 12 months post entry. The RUQ collects data on resource use while the PSI detects sources of stress in parenting roles; scores on these surveys reflect levels of disability or distress respectively. Lastly,"

Answered by AI

Are any individuals aged 20 or above eligible to participate in the research?

"To be eligible for participation, patients must range in age from 18 months to 54 months. The database hosted on clinicaltrials.gov has 513 studies enrolling those under the legal age of consent and 763 trials recruiting individuals over 65 years old."

Answered by AI

Are there any requirements for someone to become a participant in this clinical research?

"To qualify for this medical study, participants must be within the age range of 18 months to 54 months and have parental consent. 350 individuals will take part in total."

Answered by AI

Are individuals able to currently join this research project?

"Clinicaltrials.gov reports that this trial is not looking for applicants at present, even though it was first posted on August 23rd 2018 and last modified two years later. Fortunately, 1293 other medical studies are currently recruiting patients to their trials."

Answered by AI

Are there any research centers in North America currently conducting this investigation?

"Participants of this trial can be accepted at IWK Health Centre in Halifax, SSCY Centre in Winnipeg, the McGill University Health Centre's Research Institute and Montreal Children's Hospital in Montréal. Additionally there are 4 other potential locations for enrollment."

Answered by AI

Recent research and studies

Home Healthcare NurseJournal

Health Coaching

Huffman, Melinda H.. 2009. “Health Coaching”. Home Healthcare Nurse. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.nhh.0000360924.64474.04.

Medical CareJournal

Interpretation of Changes in Health-related Quality of Life

Norman, Geoffrey R., Jeff A. Sloan, and Kathleen W. Wyrwich. 2003. “Interpretation of Changes in Health-related Quality of Life”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.mlr.0000062554.74615.4c.

Arthritis & RheumatismJournal

Disability in Valued Life Activities Among Individuals with Systemic Lupus Erythematosus

Katz, Patricia, Anne Morris, Laura Trupin, Jinoos Yazdany, and Edward Yelin. 2008. “Disability in Valued Life Activities Among Individuals with Systemic Lupus Erythematosus”. Arthritis & Rheumatism. Wiley. doi:10.1002/art.23536.

Child: Care, Health and DevelopmentJournal