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Evaluation of the Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 7 more changesShow less
    • Primary completion date changed from estimate of May 31, 2026 to Aug 31, 2026
    • Enrollment target: estimated 96 to confirmed 92
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  2. Primary and study completion dates: May 31, 2025 to May 31, 2026v7
  3. Primary and study completion dates: Jun 2024 to May 31, 2025v6
  4. 2 versions Re-verified since Sep 21, 2022, no change to tracked fieldsv4-v5
  5. Primary endpoint revised
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study description shortened, about 13 words
    v3
  6. Start date changed from estimate of Sep 2021 to Sep 1, 2021v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. The investigators are also interested in service use and the cost vs. benefits of the ENGAGE approach compared to usual practice. 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 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. The investigators 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. The investigators will also ask children, parents, therapists, and managers 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 the efficiency of paediatric rehabilitation services.
Trial Details
NCT Number NCT05017363
Lead Sponsor University of Alberta
Collaborators: Alberta Health services
Conditions
(from sponsor)		 Neurodevelopmental Disorders
Related terms Neurodevelopmental Disorders
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov