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BRIGHT Coaching Program for Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880383
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
University of Alberta
Information provided by (Responsible Party):
Annette Majnemer, McGill University Health Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Parent-Child Relations Child Developmental Delay Parenting Parent-child Problem Child Development Disorder Autism Spectrum Disorder Behavioral: Coaching Behavioral: Online parent education Behavioral: Online peer support Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: In the context of the provided intervention (coaching vs. usual and locally available care) and outcome measures used (self-reported),blinding of participants, care providers, investigators nor that of the assessor is possible.
Primary Purpose: Health Services Research
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
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - Coaching

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.
Behavioral: Coaching
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.
Other Name: coaching, family support

Behavioral: Online parent education
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.
Other Name: educational resources

Behavioral: Online peer support
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.
Other Name: parent support, patient support, sharing experiences

Group 2- Partial and delayed coaching

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.

Behavioral: Online parent education
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.
Other Name: educational resources

Behavioral: Online peer support
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.
Other Name: parent support, patient support, sharing experiences




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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]) ]
    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.

  2. 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]) ]

    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.


  3. 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]) ]
    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.

  4. 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]) ]
    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).


Other Outcome Measures:
  1. Vineland Adaptive Behavior Scales (Vineland) [ Time Frame: 20-60 minutes, at baseline visit only. ]

    The Vineland is a survey that is conducted with parents or caregivers, measuring 4 domains of the child's adaptive behaviour (with 2-3 subdomains in each): the child's communication, daily living skills, socialization and motor skills. Eleven general subdomains are grouped into those four main domains. The scores of the subdomains are added to form the domain composite scores. The four domain composite scores then combine to form the adaptive behaviour composite.

    Scoring: Each subdomain question is scored on a 3-point scale: score of 2 refers to "Usually", 1 refers to "Sometimes" and 0 refers to "Never". Higher scores indicate better outcome (i.e. higher adaptive behaviour in each domain).

    The following interpretation tools/scores are provided: 1) Domains and Adaptive Behaviour Composite: Standard scores (M = 100, SD = 15), percentile ranks, adaptive levels. 2) Subdomain: V-scale score (M = 15, SD = 3), Adaptive levels, age equivalents.


  2. Readiness to receive coaching [ Time Frame: 5 minutes, at baseline visit only. ]
    This eight-question/statement screening tool was developed in-house to assess the participants' readiness to receive the coaching intervention. Each statement (e.g. "I am willing to talk, engage and share with my coach") will be rated on a 5-point Likert Scale ranging from "Strongly Disagree" to "Strongly Agree".

  3. Demographic form [ Time Frame: 10-15 minutes, at baseline visit only. ]
    Survey on sociodemographics and family structure/composition



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Months to 54 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Children are beginning to manifest delays in one or more domains of development, and they have been newly referred to a service to get assessed, diagnosed, and/ or for therapeutic intervention. Their families are thus in the early stages of their journey of getting assessment, diagnosis and/or intervention.

Inclusion Criteria:

  • 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; 9 months later, and 18 months later.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880383


Contacts
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Contact: Bahar Kasaai, PhD 514-934-1934 ext 23578 bahar.kasaai@mail.mcgill.ca
Contact: Hana Macdougall, MSc 514-934-1934 ext 23578 hana.macdougall@muhc.mcgill.ca

Locations
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Canada, British Columbia
Child Health BC, BC Children's Hospital, UBC Recruiting
Vancouver, British Columbia, Canada, V5Z 2X8
Principal Investigator: Maureen O'Donnell, MD         
Sub-Investigator: Bill McKellin, PhD         
Sub-Investigator: Jean-Paul Collet, PhD, MD         
Sub-Investigator: Theresa McElroy, PhD         
Sub-Investigator: Anton Miller, MD         
Sub-Investigator: Tammie Dewan, MD         
Canada, Manitoba
Specialized Services for Children and Youth (SSCY) Centre Recruiting
Winnipeg, Manitoba, Canada, R3E 3G1
Contact: Shayna Pierce       spierce@rccinc.ca   
Principal Investigator: Kristy Wittmeir, PhD         
Principal Investigator: Ana Hanlon-Dearman, MD         
Principal Investigator: Gina Rempel, MD         
Canada, Nova Scotia
Izaak Walton Killam (IWK) Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Erin Aubrey, MSc       Erin.Aubrey@iwk.nshealth.ca   
Principal Investigator: Jillian Filliter, PhD         
Principal Investigator: Patrick McGrath, PhD         
Principal Investigator: Tracy Kitch         
Canada, Quebec
Research Institute of McGill University Health Centre, Montreal Children's Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Sub-Investigator: Hema Patel, MD         
Sub-Investigator: Mayada Elsabbagh, PhD         
Principal Investigator: Majnemer Annette, PhD         
Sponsors and Collaborators
McGill University Health Center
Canadian Institutes of Health Research (CIHR)
University of Alberta
Investigators
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Principal Investigator: Annette Majnemer, PhD Research Institute of McGill University Health Centre
Principal Investigator: Maureen O'Donnell, MD Provincial Health Services Authority
  Study Documents (Full-Text)

Documents provided by Annette Majnemer, McGill University Health Center:
Study Protocol  [PDF] October 12, 2018


Publications:
Mazer, 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.
Kiresuk, T.J., Smith A., and Cardillo J.E. , Goal attainment scaling: Applications, theory, and measurement. Psychology Press, 2014.
Abidin, 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.
Borgatti SP, E.M., Freeman LC, Ucinet for Windows: Software for Social Network Analysis, M.H.-A.T. Cambridge, Editor. 2002.

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Responsible Party: Annette Majnemer, Professor - School of Physical & Occupational Therapy. Vice Dean - Education, Faculty of Medicine, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03880383     History of Changes
Other Study ID Numbers: 2017-3159
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annette Majnemer, McGill University Health Center:
brain-based developmental disorders
child development
preschool skills and development
parenting stress
parenting mental health
coaching intervention
online education
parent peer support
developmental delay

Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Developmental Disabilities
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders