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BRIGHT Coaching Program for Families

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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 Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE March 10, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date March 19, 2019
Actual Study Start Date  ICMJE August 23, 2018
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 15, 2019)
  • 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.
  • 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".
  • Demographic form [ Time Frame: 10-15 minutes, at baseline visit only. ]
    Survey on sociodemographics and family structure/composition
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE BRIGHT Coaching Program for Families
Official Title  ICMJE BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Mental Health Wellness 1
  • Parent-Child Relations
  • Child Developmental Delay
  • Parenting
  • Parent-child Problem
  • Child Development Disorder
  • Autism Spectrum Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Coaching
    • Behavioral: Online parent education
    • Behavioral: Online peer support
  • 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.

    Interventions:
    • Behavioral: Online parent education
    • Behavioral: Online peer support
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 54 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880383
Other Study ID Numbers  ICMJE 2017-3159
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Annette Majnemer, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • University of Alberta
Investigators  ICMJE
Principal Investigator: Annette Majnemer, PhD Research Institute of McGill University Health Centre
Principal Investigator: Maureen O'Donnell, MD Provincial Health Services Authority
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP