Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 6
- 主要终点
- Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM).
研究概览
简要总结
Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.
详细描述
PURPOSE:
This pragmatic trial aims to improve health outcomes for children with neurodevelopmental disabilities (NDD) using a novel therapist-targeted, theory-driven, evidence-based approach to goal setting, the Enhancing Child Engagement in Goal Setting (ENGAGE) approach. This study includes an economic analysis and service utilization component and an implementation process analysis to evaluate cost-effectiveness and to support long-term sustainability.
RESEARCH QUESTIONS:
Primary question: Does ENGAGE improve children's engagement in therapy, goal-related performance (primary outcome), functional abilities, participation in home, school and/or community, and child and caregiver quality of life compared to the current standard of care?
Secondary questions: 1) What goal, child, family and therapist factors mediate and/or moderate the effects of ENGAGE on the above intervention outcomes? and 2) Does ENGAGE improve cost effectiveness from the perspectives of parents and service delivery efficiency compared to the current standard of care?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Trained assessors, blinded to group allocation, will complete the measures with families. Family members will be blinded to all initial responses on the measures.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are children with a diagnosed disability who:
- •are between the ages of 5-12 years
- •are able to engage in the goal-setting process (determined by therapists)
- •are referred to PT and/or OT for a period of direct treatment
- •speak English.
- •Children will be excluded from the trial if:
- •the parent or guardian who attends therapy does not speak English
- •the child has a diagnosis that suggests developmental regression
- •the child has uncontrolled seizures (i.e., seizure within the past 2 months).
排除标准
- 未提供
研究组 & 干预措施
ENGAGE approach (child-oriented goal-setting)
Therapists will receive training on our principles-based goal setting approach and strategies in the goal setting toolbox. Training will include an overview of tools and strategies including the Perceived Efficacy and Goal Setting Tool (PEGS) and the Pediatric Activity Card Sort (PACS). In addition, we will provide training on Goal Attainment Scaling and administration of the Canadian Occupational Performance Measure (COPM). We will introduce simple strategies to assist children in identifying goals and to ensure ongoing focus on goals using principles of motivational interviewing, strategies to assess and nurture perceived competence (self-efficacy), and child-friendly feedback strategies on goal-related performance.
干预措施: ENGAGE approach (child-oriented goal-setting) (Behavioral)
Usual care
The control group will comprise of usual care.
结局指标
主要结局
Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM).
时间窗: 1) baseline (pre-treatment), 2) post-treatment (within 10 days of completing therapy), and 3) at 3-months post-treatment
Change in the COPM will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. The COPM is an interview style measure in which a child is asked by an assessor to identify goal areas and then rate their current level on a 1 to 10 scale as far as importance, satisfaction and performance. A higher score represents a more favorable outcome.
次要结局
- Child engagement in therapy will be measured using the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-SP).(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Perceived confidence will be measured using the Belief in Goal Self-Competence Scale [BiGSS].(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Participation for young children will be measured using the Participation and Environment Measure for Children & Youth (PEM-CY).(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Goal related performance will be measured using the Goal Attainment Scaling (GAS).(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Caregiver quality of life will be measured with the Caregiver Quality of Life (CarerQol-7D).(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Quality of life for children will be measured using the KIDSCREEN-27.(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)
- Functional abilities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI-CAT).(1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment)