BRIGHT Coaching: A Randomized Controlled Trial on the Effectiveness of a Developmental Coach System to Empower Families of Children With Emerging Developmental Delay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 7
- 主要终点
- Parent Sense of Competency (PSOC) Scale - change is being assessed.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Coaching (Behavioral)
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.
干预措施: Online parent education (Behavioral)
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.
干预措施: Online peer support (Behavioral)
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.
干预措施: Online parent education (Behavioral)
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.
干预措施: Online peer support (Behavioral)
结局指标
主要结局
Parent Sense of Competency (PSOC) Scale - change is being assessed.
时间窗: 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.
Family Empowerment Scale (FES) - change is being assessed.
时间窗: 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).
次要结局
- 36-Item Short Form Survey (SF-36) - change is being assessed.(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.(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.(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.(45 minutes at each study visit (at baseline, 8 months post-entry [immediately post-intervention], 12 months post-entry [follow-up]))
研究者
Annette Majnemer
Professor - School of Physical & Occupational Therapy. Vice Dean - Education, Faculty of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre