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

NCT04096430 | Recruiting

• 1 other identifier: Pro00090963
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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. 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.

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM).

  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.

  1) baseline (pre-treatment), 2) post-treatment (within 10 days of completing therapy), and 3) at 3-months post-treatment

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

Study Arms (2)

ENGAGE approach (child-oriented goal-setting)

EXPERIMENTAL

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.

Behavioral: ENGAGE approach (child-oriented goal-setting)

Usual care

NO INTERVENTION

The control group will comprise of usual care.

Interventions

ENGAGE approach (child-oriented goal-setting) BEHAVIORAL

See description of experimental arm.

ENGAGE approach (child-oriented goal-setting)

Eligibility Criteria

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

You may qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (6)

Renfrew Educational Services

Calgary, Alberta, T2E 6S5, Canada

RECRUITING

Society for Treatment of Autism

Calgary, Alberta, T2J 0E8, Canada

RECRUITING

Children's Rehabilitation Services, Alberta Health Services

Camrose, Alberta, Canada

RECRUITING

Centre for Autism Services Alberta

Edmonton, Alberta, T6E 5H5, Canada

RECRUITING

Children's Rehabilitation Services, Alberta Health Services

Grande Prairie, Alberta, Canada

RECRUITING

Children's Rehabilitation Services, Alberta Health Services

Red Deer, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Cerebral Palsy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Lesley Pritchard-Wiart, PhD

  University of Alberta, Faculty of Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesley Pritchard-Wiart, PhD

CONTACT

780-492-2971; lwiart@ualberta.ca

Sandy Thompson-Hodgetts, PhD

CONTACT

780-492-8416; sandy.hodgetts@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Trained assessors, blinded to group allocation, will complete the measures with families. Family members will be blinded to all initial responses on the measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will use a pragmatic, cluster randomized controlled trial (RCT) design with therapists randomized to one of two groups; the ENGAGE intervention group or the usual care control group.

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: September 19, 2019
• Study Start: March 1, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)