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

NCT05017363 | Recruiting

• 1 other identifier: RES0044126
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Goal-setting; Children; Engagement in Therapy

Outcome Measures

Primary Outcomes (1)

• Self-perceived, goal-related performance on the COPM (COPM-P)

  Canadian Occupational Performance Measure, Performance rating, 1 (not able to do it -10 able to do it extremely well).

  Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment.

Secondary Outcomes (4)

• Participation

  Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

• Child Quality of Life

  Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

• Parent Quality of Life

  Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

• Functional Abilities

  Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

Other Outcomes (6)

• Child engagement in therapy

  At each treatment session (session frequency will vary; estimated # of sessions is 3-10. )

• Mastery Motivation

  Baseline

• Parenting style

  Baseline

Study Arms (2)

Intervention Group (ENGAGE)

EXPERIMENTAL

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.

Procedure: ENGAGE

Usual Care Group (Control)

NO INTERVENTION

The control group will comprise usual care.

Interventions

ENGAGE PROCEDURE

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.

Intervention Group (ENGAGE)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

RECRUITING

Related Publications (1)

• Pritchard-Wiart L, Thompson-Hodgetts S, McKillop AB, Rosychuk R, Mrklas K, Zwaigenbaum L, Zwicker J, Andersen J, King G, Firouzeh P. A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol. BMC Pediatr. 2022 Jun 29;22(1):375. doi: 10.1186/s12887-022-03381-4.

  PMID: 35764983 DERIVED

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Lesley Pritchard, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Sandra Hodgetts, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesley Pritchard, PhD

CONTACT

780-492-2971; lwiart@ualberta.ca

Sandra Hodgetts, PhD

CONTACT

sandy.hodgetts@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 23, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

CA (1)