BRIGHT Coaching Program for Developmental Disabilities

No longer recruiting at 4 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a coaching program designed to support families with children who have developmental delays. The BRIGHT Coaching Program includes personalized coaching, online educational tools, and a peer support network. The trial aims to determine if this approach improves parents' confidence, reduces stress, and enhances their overall healthcare experience, compared to usual care. Families may be a good fit if they have young children showing developmental delays and are just beginning to seek assessments or interventions. As an unphased trial, this study offers families the opportunity to access innovative support strategies that could significantly enhance their caregiving experience.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on coaching and support for developmental disabilities rather than medication changes.

What prior data suggests that the BRIGHT Coaching Program is safe for children with developmental disabilities?

Research shows that the BRIGHT Coaching Program is safe for both children and their caregivers. The program provides parents with coaching, online education tools, and peer support networks to help manage their child's developmental challenges.

Past studies of similar coaching programs have reported no negative effects and have been well-received. The focus on support and education, rather than medical treatment, usually means fewer risks. Participants in those studies shared positive experiences and felt more empowered and capable.

This trial is labeled "Not Applicable" for phase, indicating the use of non-invasive methods like guidance and support, which are generally safe. This differs from drug trials, which might have more safety concerns. Prospective participants can expect the program to be safe and beneficial for both themselves and their child. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BRIGHT Coaching Program because it offers a comprehensive support system tailored to the needs of families dealing with developmental disabilities. Unlike traditional treatments that might focus solely on direct therapy for children, this program empowers parents with immediate coaching, online education, and a peer support network. The coaching is personalized, adapting to the family's unique circumstances and the child's specific condition. This holistic approach not only aims to enhance the child's development but also strengthens the family's ability to support their child effectively.

What evidence suggests that the BRIGHT Coaching Program is effective for developmental disabilities?

Research has shown that the BRIGHT Coaching Program can assist families of children with developmental delays. In this trial, participants will be divided into two groups. Group 1 will receive immediate access to the full BRIGHT Coaching Program, which includes coaching and online education, helping parents feel more capable and less stressed. Parents in this group reported better coordination in care and an improved experience with healthcare services. Group 2 will have delayed and partial access to coaching, receiving a one-time session with a developmental coach and access to online parent education and peer support tools at the end of the 18-month period. The program also connects parents with others in similar situations, providing emotional support and shared knowledge. Overall, the BRIGHT Coaching Program aims to improve the quality of life for both parents and children facing developmental challenges. ^{1 6 7 8 9}

Who Is on the Research Team?

Annette Majnemer, PhD

Principal Investigator

Research Institute of McGill University Health Centre

Maureen O'Donnell, MD

Principal Investigator

Provincial Health Services Authority

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6694748/

BRIGHT Coaching: A Randomized Controlled Trial on the ... In this paper, we have presented the background and design for a pragmatic randomized controlled trial comparing a BRIGHT Coaching program to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31440489/

BRIGHT Coaching: A Randomized Controlled Trial on the ... A randomized controlled trial on the effectiveness of a developmental coach system to empower families of children with emerging developmental delay.

3. enrrichresearch.ca enrrichresearch.ca/all-blogs/working-and-learning-across-canada-with-the-bright-coaching-team

Working and Learning across Canada with The BRIGHT ... BRIGHT Coaching is a 1:1 virtual coaching program for caregivers of preschool children with suspected developmental delay(s) who are waiting for services.

4. consensus.app consensus.app/search/what-are-the-long-term-effects-of-bright-coaching-/iLgtwmsASOuZAnTU6gEzyg/

What are the long-term effects of BRIGHT Coaching ... Current research on the long-term effects of BRIGHT Coaching for children with developmental delay is still emerging. The main randomized controlled trial ...

5. clinicaltrial.be clinicaltrial.be/nl/details/5656?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

BRIGHT Coaching Program for Families - Klinische Studies... This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual care ...

6. child-bright.ca child-bright.ca/implementation-science-research

Implementation Science Research BRIGHT Beginnings. Early intervention is key in minimizing developmental problems that children may face. Over the past decade, experimental studies ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dmcn.14810

Patient engagement in an online coaching intervention for ... To evaluate patient engagement processes in the development of a new health coaching intervention for parents of children with suspected developmental delays.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/11786329241297910

A Developmental Evaluation of the Bright Ideas Program Bright Ideas is an innovative program developed by KidsAbility's Rocket Discovery Centre, aiming enhance uptake of EIP through incubating ideas.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S014521342300385X

School-based prevention education for children and youth ... In general, the extant evidence suggests these programs are effective at increasing knowledge of child maltreatment (Bright et al., 2022), use of self- ...