Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)
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ClinicalTrials.gov Identifier: NCT04096430 |
Recruitment Status :
Recruiting
First Posted : September 19, 2019
Last Update Posted : May 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder Neurodevelopmental Disorders Cerebral Palsy | Behavioral: ENGAGE approach (child-oriented goal-setting) | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Trained assessors, blinded to group allocation, will complete the measures with families. Family members will be blinded to all initial responses on the measures. |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis |
Actual Study Start Date : | March 1, 2022 |
Estimated Primary Completion Date : | May 31, 2024 |
Estimated Study Completion Date : | May 31, 2024 |

Arm | Intervention/treatment |
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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.
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Behavioral: ENGAGE approach (child-oriented goal-setting)
See description of experimental arm. |
No Intervention: Usual care
The control group will comprise of usual care.
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- 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 ]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.
- Child engagement in therapy will be measured using the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-SP). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in the (PRIME-SP) 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.
- Perceived confidence will be measured using the Belief in Goal Self-Competence Scale [BiGSS]. [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in the BIGSS 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. BIGSS assess percieved using a 10-point Likert scale ("How confident do you feel that you can do this activity?). A higher score represents a more favorable outcome.
- Goal related performance will be measured using the Goal Attainment Scaling (GAS). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in GAS 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.
- Participation for young children will be measured using the Participation and Environment Measure for Children & Youth (PEM-CY). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in the PEM-CY 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. This questionnaire is completed by a child (if 8 years or older) or parent. The participant responds to whether they have performed the activity in the last few weeks, who they did it with, where they did it and how much they enjoyed it.
- Quality of life for children will be measured using the KIDSCREEN-27. [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in the KIDSCREEN-27 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 KIDSCREEN-27 contains 27 items covering five dimensions: physical well-being (5 items), psychological well-being (7 items), parent relations and autonomy (7 items), social support and peers (4 items), and school (4 items). Each item rates frequency of behaviours/feelings or intensity of attitudes on a 5-point scale, with a higher score reflecting a more favorable outcome.
- Caregiver quality of life will be measured with the Caregiver Quality of Life (CarerQol-7D). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in CarerQol-7D 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. CarerQol is a 7-item questionnaire that evaluates the subjective burden experienced by caregivers across seven dimensions, including fulfillment, relational problems, mental health, daily activities, financial, physical health and support along with overall well-being on a VAS scale.
- Functional abilities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI-CAT). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]Change in the PEDI-CAT will be examined between 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 PEDI-CA T includes domains that align with the I CF-CY domains of activity (daily activities, mobility, social/cognitive) and participation. A parent of each participant will complete the content-balanced version of the PEDI-CA T using iPads at each site. An algorism based on item response theory selects items to minimizes the number ofresponses required, so parents answer up to -30 items/domain.

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Ages Eligible for Study: | 5 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria are children with a diagnosed disability who:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096430
Contact: Lesley Pritchard-Wiart, PhD | 780-492-2971 | lwiart@ualberta.ca | |
Contact: Sandy Thompson-Hodgetts, PhD | 780-492-8416 | sandy.hodgetts@ualberta.ca |
Canada, Alberta | |
Renfrew Educational Services | Recruiting |
Calgary, Alberta, Canada, T2E 6S5 | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca | |
Society for Treatment of Autism | Recruiting |
Calgary, Alberta, Canada, T2J 0E8 | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca | |
Children's Rehabilitation Services, Alberta Health Services | Recruiting |
Camrose, Alberta, Canada | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca | |
Centre for Autism Services Alberta | Recruiting |
Edmonton, Alberta, Canada, T6E 5H5 | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-2971 sandy.hodgetts@ualberta.ca | |
Children's Rehabilitation Services, Alberta Health Services | Recruiting |
Grande Prairie, Alberta, Canada | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca | |
Children's Rehabilitation Services, Alberta Health Services | Recruiting |
Red Deer, Alberta, Canada | |
Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca | |
Contact: Sandy Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca |
Principal Investigator: | Lesley Pritchard-Wiart, PhD | University of Alberta, Faculty of Rehabilitation Medicine |
Responsible Party: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT04096430 |
Other Study ID Numbers: |
Pro00090963 |
First Posted: | September 19, 2019 Key Record Dates |
Last Update Posted: | May 16, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cerebral Palsy Disease Autism Spectrum Disorder Neurodevelopmental Disorders Pathologic Processes Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Child Development Disorders, Pervasive Mental Disorders |