Recruiting

Paediatric Rehabilitation

Sponsor:

University of Alberta

Code:

NCT05017363

Conditions

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

ENGAGE

Study Details

Brief summary:

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.

Conditions

Neurodevelopmental Disorders

Study ID

NCT05017363

Start date

Sep 1, 2021

Status verified date

Sep, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Referred to Physical Therapy and/or Occupational Therapy for a period of direct treatment,
  • English speaking

Exclusion Criteria:

  • Presence of a progressive condition
  • The child has uncontrolled seizures (i.e., had a seizure within the past 2 months).

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Group (ENGAGE)

Therapists will consist of pairs within sites providing similar interventions to similar children so that treatment and child characteristics other than the goal-setting intervention will be similar within each site. Therapists will use principles-based goal-setting approaches and strategies in the goal-setting toolbox. It is anticipated that treatment block lengths will vary from 3-8 sessions over 2-8 weeks, representing typical clinical variation.

no intervention: Usual Care Group (Control)

The control group will comprise usual care.

Interventions

ENGAGE

Goal-setting approach and strategies including the Perceived Efficacy and Goal Setting Tool (PEGS), which is established goal setting tools for children aged 5-9. Administration of the Canadian Occupational Performance Measure (COPM), the most widely used goal-setting tool in paediatric rehabilitation that has been used with children as young as seven years. Introducing 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.

Primary outcome measure

  • Self-perceived, goal-related performance on the COPM (COPM-P) [ Time Frame: Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment. ]

Central Contacts and Locations

Central contacts

Lesley Pritchard, PhD

780-492-2971lwiart@ualberta.ca

Sandra Hodgetts, PhD

sandy.hodgetts@ualberta.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2G4

Contacts

Principal Investigator:

Lesley Pritchard, PhD

More Information

Sponsor

University of Alberta

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • Goal-setting
  • Children
  • Engagement in Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-09-18.