Recruiting

ENGAGE Approach

Sponsor:

University of Alberta

Code:

NCT04096430

Conditions

Autism Spectrum Disorder

Neurodevelopmental Disorders

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

ENGAGE approach (child-oriented goal-setting)

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. 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

Study ID

NCT04096430

Start date

Mar 1, 2022

Status verified date

Jul, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Inclusion criteria are children with a diagnosed disability who:

1. are between the ages of 5-12 years
2. are able to engage in the goal-setting process (determined by therapists)
3. are referred to PT and/or OT for a period of direct treatment
4. speak English.

Children will be excluded from the trial if:

1. the parent or guardian who attends therapy does not speak English
2. the child has a diagnosis that suggests developmental regression
3. the child has uncontrolled seizures (i.e., seizure within the past 2 months).

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Usual care

The control group will comprise of usual care.

Interventions

ENGAGE approach (child-oriented goal-setting)

See description of experimental arm.

Primary outcome measure

  • Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days of completing therapy), and 3) at 3-months post-treatment ]

Central Contacts and Locations

Central contacts

Lesley Pritchard-Wiart, PhD

780-492-2971lwiart@ualberta.ca

Sandy Thompson-Hodgetts, PhD

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

Locations

Renfrew Educational Services

Recruiting

Calgary, Alberta, Canada, T2E 6S5

Contacts

Society for Treatment of Autism

Recruiting

Calgary, Alberta, Canada, T2J 0E8

Contacts

Children's Rehabilitation Services, Alberta Health Services

Recruiting

Camrose, Alberta, Canada

Contacts

Centre for Autism Services Alberta

Recruiting

Edmonton, Alberta, Canada, T6E 5H5

Contacts

Children's Rehabilitation Services, Alberta Health Services

Recruiting

Grande Prairie, Alberta, Canada

Contacts

Children's Rehabilitation Services, Alberta Health Services

Recruiting

Red Deer, Alberta, Canada

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-07-15.