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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

Must not have

Non-English or non-French speaking

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English or French.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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 study objectives

Demographic form

Readiness to receive coaching

Vineland Adaptive Behavior Scales (Vineland)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Online peer support

2018

N/A

~310