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BRIGHT Coaching Program for Families

Primary Purpose

Mental Health Wellness 1, Parent-Child Relations, Child Developmental Delay

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Coaching
Online parent education
Online peer support
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Wellness 1 focused on measuring brain-based developmental disorders, child development, preschool skills and development, parenting stress, parenting mental health, coaching intervention, online education, parent peer support, developmental delay

Eligibility Criteria

18 Months - 54 Months (Child)All SexesDoes not accept healthy volunteers

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; 8 months later, and 12 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.

Sites / Locations

  • Child Health BC, BC Children's Hospital, UBC
  • Specialized Services for Children and Youth (SSCY) Centre
  • Izaak Walton Killam (IWK) Health Centre
  • Research Institute of McGill University Health Centre, Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group 1 - Coaching

Group 2- Partial and delayed coaching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
March 10, 2019
Last Updated
October 19, 2023
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03880383
Brief Title
BRIGHT Coaching Program for Families
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR), University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Parent-Child Relations, Child Developmental Delay, Parenting, Parent-child Problem, Child Development Disorder, Autism Spectrum Disorder
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Coaching
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2- Partial and delayed coaching
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Other Intervention Name(s)
coaching, family support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online parent education
Other Intervention Name(s)
educational resources
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online peer support
Other Intervention Name(s)
parent support, patient support, sharing experiences
Intervention Description
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.
Primary Outcome Measure Information:
Title
Family Empowerment Scale (FES) - change is being assessed.
Description
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).
Time Frame
10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Title
Parent Sense of Competency (PSOC) Scale - change is being assessed.
Description
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.
Time Frame
10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Secondary Outcome Measure Information:
Title
36-Item Short Form Survey (SF-36) - change is being assessed.
Description
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.
Time Frame
7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Title
Parenting Stress Index - 36 (PSI-36) - change is being assessed.
Description
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.
Time Frame
7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Title
Measure of Process of Care - 20 (MPOC - 20) - change is being assessed.
Description
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.
Time Frame
10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Title
Resource Utilization Questionnaire - Preschoolers (RUQ-P) - change is being assessed.
Description
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).
Time Frame
45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up])
Other Pre-specified Outcome Measures:
Title
Vineland Adaptive Behavior Scales (Vineland)
Description
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.
Time Frame
20-60 minutes, at baseline visit only.
Title
Readiness to receive coaching
Description
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".
Time Frame
5 minutes, at baseline visit only.
Title
Demographic form
Description
Survey on sociodemographics and family structure/composition
Time Frame
10-15 minutes, at baseline visit only.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
Eligibility 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; 8 months later, and 12 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Majnemer, PhD
Organizational Affiliation
Research Institute of McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen O'Donnell, MD
Organizational Affiliation
Provincial Health Services Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child Health BC, BC Children's Hospital, UBC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2X8
Country
Canada
Facility Name
Specialized Services for Children and Youth (SSCY) Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3G1
Country
Canada
Facility Name
Izaak Walton Killam (IWK) Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Research Institute of McGill University Health Centre, Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time, plan has not been created
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BRIGHT Coaching Program for Families

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