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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

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

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

888 Previous Clinical Trials

384,862 Total Patients Enrolled

7 Trials studying Autism Spectrum Disorder

1,595 Patients Enrolled for Autism Spectrum Disorder

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,570 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many establishments in Canada are currently administering this research endeavor?

"Currently, 6 sites across the nation are enrolling participants for this trial. Locations include Camrose, Grande Prairie and Edmonton as well as other nearby areas; thus, selecting a site close by can reduce travelling expenses if you choose to join in on the study."

Answered by AI

How many participants have been included in this research endeavor?

"Affirmative. Clinicaltrials.gov attest that this clinical study, which was initial posted on March 1st 2022, is actively recruiting patients for the trial. Approximately 96 participants are required from 6 different sites to complete the research project."

Answered by AI

Who has been given the opportunity to take part in this medical experiment?

"This clinical trial is aimed at 96 children aged 5 to 12 with an Autism Spectrum Disorder diagnosis, who are able to engage in goal-setting activities (as judged by their therapist), must have experienced a developmental regression symptom, be conversant in the English language (with non-English speaking parents or guardians attending therapy sessions) and have not had any seizures within the past two months."

Answered by AI

Is this research endeavor presently recruiting participants?

"Affirmative. The clinical trial's listing on clinicaltrials.gov reveals that this medical endeavor, which was launched March 1st 2022, is presently recruiting participants. 96 people are needed to be recruited from 6 separate locations."

Answered by AI

Could participants of 75+ years partake in this investigation?

"The age range for this medical trial is 5 to 12 years old. More precisely, there are currently 565 clinical trials available for minors and 678 studies open to seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04096430.

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