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Child-Oriented Goal-Setting for Pediatric Rehabilitation

N/A
Recruiting
Led By Lesley Pritchard-Wiart, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children who speak English
Children between the ages of 5-12 years with a diagnosed disability
Must not have
Parent or guardian who attends therapy does not speak English
Child with a diagnosis that suggests developmental regression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes.

Who is the study for?
This trial is for children aged 5-12 with neurodevelopmental disabilities like autism or cerebral palsy, who are referred to physical or occupational therapy and can participate in goal-setting. They must speak English, as should their guardian. Children with developmental regression or uncontrolled seizures are excluded.
What is being tested?
The ENGAGE approach focuses on child-oriented goal-setting in pediatric rehabilitation. The study compares the effectiveness of ENGAGE against usual therapy practices by assessing improvements in children's abilities, participation levels, and quality of life for both the child and family.
What are the potential side effects?
Since this trial involves non-medical interventions focused on goal setting within therapy sessions rather than drugs or medical procedures, traditional side effects are not applicable. However, there may be varying emotional responses from participants to different therapeutic approaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child speaks English.
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My child is between 5-12 years old and has a diagnosed disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child's guardian attending therapy is not an English speaker.
Select...
My child has been diagnosed with developmental regression.
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My child has had a seizure in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM).
Secondary study objectives
Caregiver quality of life will be measured with the Caregiver Quality of Life (CarerQol-7D).
Child engagement in therapy will be measured using the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-SP).
Functional abilities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI-CAT).
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ENGAGE approach (child-oriented goal-setting)Experimental Treatment1 Intervention
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.
Group II: Usual careActive Control1 Intervention
The control group will comprise of usual care.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,935 Total Patients Enrolled
7 Trials studying Autism Spectrum Disorder
1,551 Patients Enrolled for Autism Spectrum Disorder
Alberta Health servicesOTHER
163 Previous Clinical Trials
652,562 Total Patients Enrolled
2 Trials studying Autism Spectrum Disorder
467 Patients Enrolled for Autism Spectrum Disorder
Lesley Pritchard-Wiart, PhDPrincipal InvestigatorUniversity of Alberta, Faculty of Rehabilitation Medicine

Media Library

ENGAGE approach (child-oriented goal-setting) Clinical Trial Eligibility Overview. Trial Name: NCT04096430 — N/A
Autism Spectrum Disorder Research Study Groups: ENGAGE approach (child-oriented goal-setting), Usual care
Autism Spectrum Disorder Clinical Trial 2023: ENGAGE approach (child-oriented goal-setting) Highlights & Side Effects. Trial Name: NCT04096430 — N/A
ENGAGE approach (child-oriented goal-setting) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04096430 — N/A
~15 spots leftby May 2025