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Child-oriented Goal-setting for Neurodevelopmental Disorders

N/A

Recruiting

Led By Lesley Pritchard, 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

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is testing the effects of a child-focussed goal-setting approach on therapy outcomes, compared to usual practice. The goal is to improve child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life.

Who is the study for?

This trial is for English-speaking children aged 5-12 with neurodevelopmental disabilities who are referred to Physical or Occupational Therapy. It's not suitable for kids with progressive conditions or uncontrolled seizures (having had a seizure in the last 2 months).Check my eligibility

What is being tested?

The ENGAGE approach, which involves child-focused goal-setting in therapy, is being tested against usual therapy practices. The study will see if ENGAGE improves goal performance, functional abilities, participation, and quality of life.See study design

What are the potential side effects?

Since this trial tests a therapeutic strategy rather than a medication, traditional side effects aren't expected. However, there may be differences in personal experiences during the rehabilitation process.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 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

Self-perceived, goal-related performance on the COPM (COPM-P)

Secondary outcome measures

Child Quality of Life

Functional Abilities

Parent Quality of Life

+1 more

Other outcome measures

Autonomy

Child engagement in therapy

Child-rated experience measure of practitioner empathy

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group (ENGAGE)Experimental Treatment1 Intervention

Therapists will consist of pairs within sites providing similar interventions to similar children so that treatment and child characteristics other than the goal-setting intervention will be similar within each site. Therapists will use principles-based goal-setting approaches and strategies in the goal-setting toolbox. It is anticipated that treatment block lengths will vary from 3-8 sessions over 2-8 weeks, representing typical clinical variation.

Group II: Usual Care Group (Control)Active Control1 Intervention

The control group will comprise usual care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ENGAGE

2013

Completed Phase 2

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,042 Total Patients Enrolled

3 Trials studying Neurodevelopmental Disorders

680 Patients Enrolled for Neurodevelopmental Disorders

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,570 Total Patients Enrolled

2 Trials studying Neurodevelopmental Disorders

226 Patients Enrolled for Neurodevelopmental Disorders

Lesley Pritchard, PhDPrincipal InvestigatorUniversity of Alberta

Media Library

ENGAGE Clinical Trial Eligibility Overview. Trial Name: NCT05017363 — N/A

Neurodevelopmental Disorders Research Study Groups: Usual Care Group (Control), Intervention Group (ENGAGE)

Neurodevelopmental Disorders Clinical Trial 2023: ENGAGE Highlights & Side Effects. Trial Name: NCT05017363 — N/A

ENGAGE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05017363 — N/A

Frequently Asked Questions

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

What is the maximum amount of individuals eligible to participate in this research?

"Affirmative. Clinicaltrials.gov attests that this research is presently recruiting participants, having been posted on September 1st 2021 and updated lastly on the 21th of September 2022. The investigation requires 96 individuals from a single medical site to enrol in it."

Answered by AI

Is the eligibility criterion for this clinical trial restricted to those under forty years of age?

"As outlined in the inclusion criteria, individuals between ages 5 and 12 can enter this clinical trial."

Answered by AI

What objectives are being sought in this medical research?

"The primary endpoints of this trial will be assessed by comparing pre-treatment and post-treatment scores within a 10 day period, as well as between post treatment and 3 months after. The main measure used is self-perceived goal related performance. Other secondary objectives are participation (PEM-CY), parent quality of life (CarerQol7D) and child quality of life (KIDSCREEN10)."

Answered by AI

Are there any opportunities for participation in this experiment currently available?

"Clinicaltrials.gov indicates that this clinical trial is actively seeking participants; it was initially posted on September 1st 2021 and was last updated on the 21st of the same month in 2022."

Answered by AI