Mental Health Wellness 1NCT03880383
BRIGHT Coaching Program for Families
A study testing Coaching, Online parent education and Online peer support in people with Mental Health Wellness 1 and Parent-Child Relations, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 months
- Conditions the study is for
- Mental Health Wellness 1, Parent-Child Relations, Child Developmental Delay
- What is being tested?
- Coaching, Online parent education and Online peer support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 4 sitesCanada
- Study dates
- 23 Aug 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Izaak Walton Killam (IWK) Health Centre
Halifax, Nova Scotia, B3K 6R8
Research Institute of McGill University Health Centre, Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Child Health BC, BC Children's Hospital, UBC
Vancouver, British Columbia, V5Z 2X8
Specialized Services for Children and Youth (SSCY) Centre
Winnipeg, Manitoba, R3E 3G1
About this study
Official title: BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay
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:
- 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.
- 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.
Read the detailed description
Rationale:
Children with, or at elevated risk for, brain-based developmental disabilities experience chronic lifelong functional consequences with new challenges emerging at each stage of development. In the preschool years (3-6 years), needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioural and social skills. The preschool years are a time of stress for families as young child awaits assessment, or even as they receive services for brain-based disorders. Similarly, the system and society struggle to meet needs of families in a timely and appropriate manner in the face of escalating costs. Given these struggles, there is a need to examine whether a health-coach style of intervention coupled with parent education delivered through an online platform can be effective in empowering families, by delivering information, providing social (parent to parent) supports, and decreasing demand on health and developmental services. This innovation provides a significant service re-design in a system at critical point of transition.
Study objective:
To evaluate the feasibility and the effectiveness (changes in parent health, developmental service utilization and cost effectiveness) of a self-management intervention (including developmental coach, online education tools and support network), when compared to usual and locally available care in service delivery practices, for parents of preschool children with suspected developmental delays.
Methodology / Study design:
This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The target population for this novel service delivery model is children aged 1.5 to 4.5 years old who are at a high risk for or suspected of having developmental delays, that are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural). In the first year, a technology-supported health coach service delivery model will be developed in conjunction with families. A feasibility/acceptability pilot study was conducted to ensure that the intervention is feasible in the real life context across 4 participating Canadian provinces.
Participants:
Eligible children and their families will be recruited to include children who are 1.5 to 4.5 years at the age at enrolment. Children will be living in four diverse parts of Canada to ensure national representation and future scalability: Vancouver; Winnipeg; Montreal and Halifax. Participants' postal codes will be analyzed to ensure representation: rural/remote, small urban and large urban/metro representation with purposeful sampling as required. From the patient population perspective, two different groups that are likely to manifest new global developmental delays at this stage will be recruited. They are at high risk for brain-based developmental delays, however some will have no delay and others will have mild, moderate or severe delays.
Study procedures: Intervention and control Recruitment begins with family contact. Families are contacted via the centre to which they were referred for developmental diagnosis and assessment. A member of the clinical team will ask if they are interested to learn more about the BRIGHT Coaching study. If interested, the families' contact information will be shared with the local research assistant (RA) overseeing the trial. The RA will speak to a parent by phone and follow up with an introductory letter by mail explaining the procedures of the study, together with the consent form and a self-addressed stamped envelope to return to the RA if interested in participating. After 2 weeks, if no consent form is received, the RA will call the family once again to determine their interest in participating. Once consent is signed, participants will conduct baseline assessments including documentation of their care and social networks, and be randomized using a computer-generated algorithm; randomization will be stratified by site. The allocation ratio for intervention or control will be 1:1 for each site.
- Conditions
- Mental Health Wellness 1, Parent-Child Relations, Child Developmental Delay, Parenting, Parent-child Problem, Child Development Disorder
- Being tested
- Coaching, Online parent education, Online peer support
- Keywords
- brain-based developmental disorders, child development, preschool skills and development, parenting stress, parenting mental health, coaching intervention, online education, parent peer support, developmental delay
- Medical subject headings
- Learning Disabilities, Developmental Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingBehavioural
Also called coaching, family support
Parents will interact and communicate regularly with a coach in person or by telephone. Coaches will be responsible for: identifying developmental concerns, proactive health promotion, guidance and training for developmental stimulation, parent support and education about child development, navigation of the health care system and self-management techniques. The frequency of coaching will be: once a month (minimum), for 18 months, at an average of 2.5 hours per month.
Online parent educationBehavioural
Also called educational resources
Parents will be provided access to an online platform which will provide educational resources and access to parent-parent support. Online resources on child development are curated by researchers and representative of parent groups, and linked to this online platform. The themes covered in the online tool include resources on child development, accessing health care services and managing emotions and family dynamics. These topics range from: practical tips for managing day-to-day challenges, strategies to cope and support the child's transitions from one stage to another, practical tips when looking for developmental services for the child: knowing where and how to access services.
Online peer supportBehavioural
Also called parent support, patient support, sharing experiences
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. This will put each family at the centre of each network (family, friends, health providers), allowing family networks to link with one another. Families will be able to find resources, create connections with the coach, health providers and other families, thus creating a network to support one another.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Coaching | Experimental | 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. Receives: Behavioral: Coaching; Behavioral: Online parent education; Behavioral: Online peer support |
| Group 2- Partial and delayed coaching | Other | 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. Receives: Behavioral: Online parent education; Behavioral: Online peer support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Empowerment Scale (FES) - change is being assessed.
The FES is composed of 34 statements that describe how a parent or caregiver of a child with an emotional, behavioral and/or developmental challenges may feel about his or her situation (i.e. sense of empowerment). For each statement, the participant is asked to circle the response that best describes how the statement applies to him/her. The scale ranges from 1 (Not True at All) to 5 (Very True), for a maximum of 170 points and a minimum of 34 points. A higher score represent a higher sense of empowerment (i.e. better outcome).
Measured: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Parent Sense of Competency (PSOC) Scale - change is being assessed.
The PSOC measures parents' sense of competence and is a 17-item scale, with 2 subscales. Each item is rated on a 6-point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". A higher score indicates a higher parenting sense of competency.
Measured: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Secondary outcomes (4)
36-Item Short Form Survey (SF-36) - change is being assessed.
36-question survey about parental well-being and health-related quality of life. The following domains are being assessed: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Participant is asked to rate his/her ability for each statement as "Yes, Limited a lot", "Yes, Limited a Little", or "No, Not Limited at all". The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability.
Measured: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Parenting Stress Index - 36 (PSI-36) - change is being assessed.
The PSI is a self-report screening tool that helps providers and families identify the sources and different types of stress that come with parenting. Parents report their level of agreement with 36 items that fall into three subscales:
- Parental Distress (PD)-The extent to which parents feel competent, restricted, conflicted, supported, and/or depressed in their role as a parent.
- Parent-Child Dysfunctional Interaction (P-CDI)-The extent to which parents feel satisfied with their child and their interactions with them.
- Difficult Child (DC)-How a parent perceives their child to be, whether the child is easy or difficult to take care of.
- Total Stress-indication of overall level of stress a person is feeling in their role as a parent.
For most items, parents should respond by circling SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Raw scores are added and higher scores represent higher stress levels.
Measured: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Measure of Process of Care - 20 (MPOC - 20) - change is being assessed.
20-item survey measuring the extent to which care is family-centred. Participants need to select one option (ranging from 0-7 or "Not applicable" to "A very great extent") that best applies to them for each statement. Raw scores are being summed (for a maximum of 140 points and a minimum of 0 points) and higher scores represent higher perceived family-centred care that the family is receiving.
Measured: 10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Resource Utilization Questionnaire - Preschoolers (RUQ-P) - change is being assessed.
The RUQ-P collected data on resource use; service intensity; and out-of-pocket costs, such as hourly rates, costs of materials, and travel costs. The following services/resources are being assessed: Speech-Language or Communication Services; Occupational Therapy; Physiotherapy; Child-focused recreational activities; Intervention/Consultation for Challenging Behaviour; Structured/Systematic Teaching with Specific Goals (Optional); Relationship-Based Intervention ; Medication/Supplements and Special diet; Visits with additional Health Professionals; Parents' Use of Health Services and Medications and Other Resources; Purchased Materials, Equipment, etc.; Respite; Time Associated with Treatment and Care; Government Tax Rebates, Deductions, Subsidies and Other Supports; Insurance Plan. For each question/statement, a multiple choice of responses are provided and participant is asked to select one. Responses are analysed using descriptive statistics (frequencies of selected answers).
Measured: 45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start23 Aug 2018
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual and locally available care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The control group will be provided with partial intervention at the end of the 18 month study. The target population for this novel service delivery model is families with children aged 1.5 to 4.5 years old with developmental concerns, who are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural).
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Responsible party
- Principal investigator, Annette Majnemer, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Annette Majnemer, PhD, Principal investigator, Research Institute of McGill University Health CentreMaureen O'Donnell, MD, Principal investigator, Provincial Health Services Authority British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880383
- Sponsor's protocol ID
- 2017-3159
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2019
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, plan has not been created
Publications
Majnemer A, Limperopoulos C, Shevell MI, Rohlicek C, Rosenblatt B, Tchervenkov C. A new look at outcomes of infants with congenital heart disease. Pediatr Neurol. 2009 Mar;40(3):197-204. doi: 10.1016/j.pediatrneurol.2008.09.014.
PubMed 19218033Vohr B. Long-term outcomes of moderately preterm, late preterm, and early term infants. Clin Perinatol. 2013 Dec;40(4):739-51. doi: 10.1016/j.clp.2013.07.006. Epub 2013 Sep 20.
PubMed 24182959Mazer, B., Majnemer, A., and Shevell M., Service utilization and health promotion of children with neuro-developmental disabilities. Neurodevelopmental disabilities: Clinical and scientific foundation, 2009: p. p. 426-441.
Grilli L, Feldman DE, Swaine B, Gosselin J, Champagne F, Pineault R. Wait times for paediatric rehabilitation. Healthc Policy. 2007 Feb;2(3):e171-87.
PubMed 19305712Miller AR, Condin CJ, McKellin WH, Shaw N, Klassen AF, Sheps S. Continuity of care for children with complex chronic health conditions: parents' perspectives. BMC Health Serv Res. 2009 Dec 21;9:242. doi: 10.1186/1472-6963-9-242.
PubMed 20025770Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
PubMed 10413387Leahey TM, Wing RR. A randomized controlled pilot study testing three types of health coaches for obesity treatment: Professional, peer, and mentor. Obesity (Silver Spring). 2013 May;21(5):928-34. doi: 10.1002/oby.20271.
PubMed 23784896Huffman MH. HEALTH COACHING: a fresh, new approach to improve quality outcomes and compliance for patients with chronic conditions. Home Healthc Nurse. 2009 Sep;27(8):490-6; quiz 496-8. doi: 10.1097/01.NHH.0000360924.64474.04.
PubMed 19745624Kiresuk, T.J., Smith A., and Cardillo J.E. , Goal attainment scaling: Applications, theory, and measurement. Psychology Press, 2014.
Ottenbacher KJ, Msall ME, Lyon N. Measuring developmental and functional status in children with disabilities. Pediatr Phys Ther. 2000 Winter;12(4):198-9. No abstract available.
PubMed 17091034Abidin, R.R., PARENTING STRESS INDEX (4th ed.). 2012: Lutz, FL: PAR.
Koren PE, D.N., Friesen BJ. , Measuring empowerment in families whose children have emotional disabilities: a brief questionnaire. Rehabilitation Psychology, 1992. 37(4): p. 305.
Ohan JL, L.D., Johnston C., The Parenting Sense of Competence scale: Evidence of a stable factor structure and validity. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement, 2000 Oct. 32(4): p. 251.
Ware JE, S.K., Kosinski M, Gandek B, SF-36 HEALTH SURVEY MANUAL AND INTERPRETATION GUIDE, M.T.H.I. Boston, New England Medical Center, Editor. 1993.
Dyke P, Buttigieg P, Blackmore AM, Ghose A. Use of the measure of process of care for families (MPOC-56) and service providers (MPOC-SP) to evaluate family-centred services in a paediatric disability setting. Child Care Health Dev. 2006 Mar;32(2):167-76. doi: 10.1111/j.1365-2214.2006.00604.x.
PubMed 16441851
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay
- ClinicalTrials.gov ID
- NCT03880383
- Acronym / sponsor ID
- 2017-3159
- Conditions
- Mental Health Wellness 1, Parent-Child Relations, Child Developmental Delay, Parenting, Parent-child Problem, Child Development Disorder
- Keywords
- brain-based developmental disorders, child development, preschool skills and development, parenting stress, parenting mental health, coaching intervention, online education, parent peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Rationale:
Children with, or at elevated risk for, brain-based developmental disabilities experience chronic lifelong functional consequences with new challenges emerging at each stage of development. In the preschool years (3-6 years), needs arise from vulnerabilities linked to critical and newly emerging cognitive, speech, motor, behavioural and social skills. The preschool years are a time of stress for families as young child awaits assessment, or even as they receive services for brain-based disorders. Similarly, the system and society struggle to meet needs of families in a timely and appropriate manner in the face of escalating costs. Given these struggles, there is a need to examine whether a health-coach style of intervention coupled with parent education delivered through an online platform can be effective in empowering families, by delivering information, providing social (parent to parent) supports, and decreasing demand on health and developmental services. This innovation provides a significant service re-design in a system at critical point of transition.
Study objective:
To evaluate the feasibility and the effectiveness (changes in parent health, developmental service utilization and cost effectiveness) of a self-management intervention (including developmental coach, online education tools and support network), when compared to usual and locally available care in service delivery practices, for parents of preschool children with suspected developmental delays.
Methodology / Study design:
This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The target population for this novel service delivery model is children aged 1.5 to 4.5 years old who are at a high risk for or suspected of having developmental delays, that are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural). In the first year, a technology-supported health coach service delivery model will be developed in conjunction with families. A feasibility/acceptability pilot study was conducted to ensure that the intervention is feasible in the real life context across 4 participating Canadian provinces.
Participants:
Eligible children and their families will be recruited to include children who are 1.5 to 4.5 years at the age at enrolment. Children will be living in four diverse parts of Canada to ensure national representation and future scalability: Vancouver; Winnipeg; Montreal and Halifax. Participants' postal codes will be analyzed to ensure representation: rural/remote, small urban and large urban/metro representation with purposeful sampling as required. From the patient population perspective, two different groups that are likely to manifest new global developmental delays at this stage will be recruited. They are at high risk for brain-based developmental delays, however some will have no delay and others will have mild, moderate or severe delays.
Study procedures: Intervention and control Recruitment begins with family contact. Families are contacted via the centre to which they were referred for developmental diagnosis and assessment. A member of the clinical team will ask if they are interested to learn more about the BRIGHT Coaching study. If interested, the families' contact information will be shared with the local research assistant (RA) overseeing the trial. The RA will speak to a parent by phone and follow up with an introductory letter by mail explaining the procedures of the study, together with the consent form and a self-addressed stamped envelope to return to the RA if interested in participating. After 2 weeks, if no consent form is received, the RA will call the family once again to determine their interest in participating. Once consent is signed, participants will conduct baseline assessments including documentation of their care and social networks, and be randomized using a computer-generated algorithm; randomization will be stratified by site. The allocation ratio for intervention or control will be 1:1 for each site.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, two-arm pragmatic randomized controlled trial (RCT) comparing a developmental coaching and e-health services intervention plus usual and locally available care to the control state in which children and their families receive usual and locally available care over an 18-month time frame. The control group will be provided with partial intervention at the end of the 18 month study. The target population for this novel service delivery model is families with children aged 1.5 to 4.5 years old with developmental concerns, who are beginning to manifest impairments in developmental domains (e.g. motor, cognitive, speech, social and/or behavioural).
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Coaching | Experimental | Behavioral: Coaching, Behavioral: Online parent education, Behavioral: Online peer supportUpon 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. |
| Group 2- Partial and delayed coaching | Other | Behavioral: Online parent education, Behavioral: Online peer supportParents 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. |
Who may qualify
- Ages
- 18 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingAlso: coaching, family supportParents will interact and communicate regularly with a coach in person or by telephone. Coaches will be responsible for: identifying developmental concerns, proactive health promotion, guidance and training for developmental stimulation, parent support and education about child development, navigation of the health care system and self-management techniques. The frequency of coaching will be: once a month (minimum), for 18 months, at an average of 2.5 hours per month. | Behavioural | Group 1 - Coaching |
| Online parent educationAlso: educational resourcesParents will be provided access to an online platform which will provide educational resources and access to parent-parent support. Online resources on child development are curated by researchers and representative of parent groups, and linked to this online platform. The themes covered in the online tool include resources on child development, accessing health care services and managing emotions and family dynamics. These topics range from: practical tips for managing day-to-day challenges, strategies to cope and support the child's transitions from one stage to another, practical tips when looking for developmental services for the child: knowing where and how to access services. | Behavioural | Group 1 - Coaching, Group 2- Partial and delayed coaching |
| Online peer supportAlso: parent support, patient support, sharing experiencesParents 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. This will put each family at the centre of each network (family, friends, health providers), allowing family networks to link with one another. Families will be able to find resources, create connections with the coach, health providers and other families, thus creating a network to support one another. | Behavioural | Group 1 - Coaching, Group 2- Partial and delayed coaching |
Primary outcome
Family Empowerment Scale (FES) - change is being assessed.
Time frame: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
The FES is composed of 34 statements that describe how a parent or caregiver of a child with an emotional, behavioral and/or developmental challenges may feel about his or her situation (i.e. sense of empowerment). For each statement, the participant is asked to circle the response that best describes how the statement applies to him/her. The scale ranges from 1 (Not True at All) to 5 (Very True), for a maximum of 170 points and a minimum of 34 points. A higher score represent a higher sense of empowerment (i.e. better outcome).
Parent Sense of Competency (PSOC) Scale - change is being assessed.
Time frame: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
The PSOC measures parents' sense of competence and is a 17-item scale, with 2 subscales. Each item is rated on a 6-point Likert scale anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". A higher score indicates a higher parenting sense of competency.
4 secondary outcomes
36-Item Short Form Survey (SF-36) - change is being assessed.
Time frame: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Parenting Stress Index - 36 (PSI-36) - change is being assessed.
Time frame: 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Measure of Process of Care - 20 (MPOC - 20) - change is being assessed.
Time frame: 10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Resource Utilization Questionnaire - Preschoolers (RUQ-P) - change is being assessed.
Time frame: 45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 19218033Majnemer A, Limperopoulos C, Shevell MI, Rohlicek C, Rosenblatt B, Tchervenkov C. A new look at outcomes of infants with congenital heart disease. Pediatr Neurol. 2009 Mar;40(3):197-204. doi: 10.1016/j.pediatrneurol.2008.09.014.
- Background: PubMed 24182959Vohr B. Long-term outcomes of moderately preterm, late preterm, and early term infants. Clin Perinatol. 2013 Dec;40(4):739-51. doi: 10.1016/j.clp.2013.07.006. Epub 2013 Sep 20.
- BackgroundMazer, B., Majnemer, A., and Shevell M., Service utilization and health promotion of children with neuro-developmental disabilities. Neurodevelopmental disabilities: Clinical and scientific foundation, 2009: p. p. 426-441.
- Background: PubMed 19305712Grilli L, Feldman DE, Swaine B, Gosselin J, Champagne F, Pineault R. Wait times for paediatric rehabilitation. Healthc Policy. 2007 Feb;2(3):e171-87.
- Background: PubMed 20025770Miller AR, Condin CJ, McKellin WH, Shaw N, Klassen AF, Sheps S. Continuity of care for children with complex chronic health conditions: parents' perspectives. BMC Health Serv Res. 2009 Dec 21;9:242. doi: 10.1186/1472-6963-9-242.
- Background: PubMed 10413387Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
- Background: PubMed 23784896Leahey TM, Wing RR. A randomized controlled pilot study testing three types of health coaches for obesity treatment: Professional, peer, and mentor. Obesity (Silver Spring). 2013 May;21(5):928-34. doi: 10.1002/oby.20271.
- Background: PubMed 19745624Huffman MH. HEALTH COACHING: a fresh, new approach to improve quality outcomes and compliance for patients with chronic conditions. Home Healthc Nurse. 2009 Sep;27(8):490-6; quiz 496-8. doi: 10.1097/01.NHH.0000360924.64474.04.
- BackgroundKiresuk, T.J., Smith A., and Cardillo J.E. , Goal attainment scaling: Applications, theory, and measurement. Psychology Press, 2014.
- Background: PubMed 17091034Ottenbacher KJ, Msall ME, Lyon N. Measuring developmental and functional status in children with disabilities. Pediatr Phys Ther. 2000 Winter;12(4):198-9. No abstract available.
- BackgroundAbidin, R.R., PARENTING STRESS INDEX (4th ed.). 2012: Lutz, FL: PAR.
- BackgroundKoren PE, D.N., Friesen BJ. , Measuring empowerment in families whose children have emotional disabilities: a brief questionnaire. Rehabilitation Psychology, 1992. 37(4): p. 305.
- Individual participant dataSharing planned: No. At this time, plan has not been created
Related trials for Mental Health Wellness 1
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Not yet recruiting
Cognitive Intervention for Children and Adolescents With NF1
Neurofibromatosis 1 (NF1), Executive Function (Cognition)
Not yet recruiting
Online Intervention To Improve Motivation
Schizophrenia Prodromal, SCHIZOPHRENIA 1 (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Majnemer, PhD principal investigator
Research Institute of McGill University Health Centre
Maureen O'Donnell, MD principal investigator
Provincial Health Services Authority British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching, Online parent education and Online peer support in people with Mental Health Wellness 1 and Parent-Child Relations, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Empowerment Scale (FES) - change is being assessed. (time frame: 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880383, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.