Autism Spectrum Disorder Clinical Trial
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: 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.
Status | Active, not recruiting |
Enrollment | 350 |
Est. completion date | March 2024 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months to 54 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Izaak Walton Killam (IWK) Health Centre | Halifax | Nova Scotia |
Canada | Research Institute of McGill University Health Centre, Montreal Children's Hospital | Montréal | Quebec |
Canada | Child Health BC, BC Children's Hospital, UBC | Vancouver | British Columbia |
Canada | Specialized Services for Children and Youth (SSCY) Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | Canadian Institutes of Health Research (CIHR), University of Alberta |
Canada,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Vineland Adaptive Behavior Scales (Vineland) | 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. |
20-60 minutes, at baseline visit only. | |
Other | Readiness to receive coaching | 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". | 5 minutes, at baseline visit only. | |
Other | Demographic form | Survey on sociodemographics and family structure/composition | 10-15 minutes, at baseline visit only. | |
Primary | 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). | 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) | |
Primary | 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. | 10-15 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) | |
Secondary | 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. | 7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) | |
Secondary | 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. |
7-10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) | |
Secondary | 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. | 10 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) | |
Secondary | 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). | 45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]) |
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