What is the mechanism of action of this treatment?

Common treatments for Neurodevelopmental Disorders, such as ADHD and ASD, include pharmacological and behavioral interventions. Pharmacological treatments, like stimulants (e.g., methylphenidate) and non-stimulants (e.g., atomoxetine), work by modulating neurotransmitter levels to improve attention and reduce hyperactivity. Behavioral interventions, such as those used in the ENGAGE approach, focus on enhancing child engagement through goal-setting, which helps improve functional abilities and participation in daily activities. These treatments are crucial as they address both the neurological and behavioral aspects of the disorders, leading to better overall outcomes for patients.

What side effects are associated with this type of intervention?

Common treatments for neurodevelopmental disorders, particularly ADHD, include stimulant medications such as methylphenidate and amphetamines, and non-stimulant medications like atomoxetine and guanfacine. Known side effects of stimulant medications can include decreased appetite, insomnia, stomach pain, and potential impacts on growth rates. Non-stimulant medications may cause side effects such as fatigue, nausea, and potential cardiovascular effects. Behavioral therapies, like those used in the ENGAGE trial, focus on improving functional abilities and participation without the pharmacological side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of neurodevelopmental disorders in children and adolescents. For ADHD, commonly approved medications include stimulants like methylphenidate and amphetamines, as well as non-stimulants such as atomoxetine and extended-release guanfacine. Atomoxetine has been shown to be effective in long-term treatment, while guanfacine extended-release is often used in combination with stimulants. For autism spectrum disorders, while there are no medications specifically approved to treat the core symptoms, certain antipsychotics like risperidone and aripiprazole have been approved to manage irritability associated with the condition. These treatments align with the goals of the ENGAGE trial, which aims to improve functional abilities and participation in children with neurodevelopmental disabilities.

What other types of research exist?

Promising alternatives to the ENGAGE approach for neurodevelopmental disorders include: 1) Robot-Assisted Therapy, which uses personalized and exploratory modes to engage children with ASD in therapy sessions; 2) Sensory Integration Therapy, which addresses sensory processing issues common in neurodevelopmental disorders; and 3) Solution-Focused Coaching, which emphasizes participation-oriented goals and has shown high engagement in youth with cerebral palsy. These methods offer innovative ways to enhance therapy outcomes through personalized and engaging strategies.

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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

Must not have

Presence of a progressive condition

The child has uncontrolled seizures (i.e., had a seizure within the past 2 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new approach called ENGAGE, which helps children with neurodevelopmental disabilities set and achieve personal goals during therapy. The aim is to see if involving children more in goal-setting improves their therapy outcomes and 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).

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition is getting worse over time.

Select...

My child has had a seizure in the last 2 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Child Quality of Life

Functional Abilities

Parent Quality of Life

+1 more

Other study objectives

Autonomy

Child engagement in therapy

Child-rated experience measure of practitioner empathy

+3 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: 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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neurodevelopmental Disorders, such as ADHD and ASD, include pharmacological and behavioral interventions. Pharmacological treatments, like stimulants (e.g., methylphenidate) and non-stimulants (e.g., atomoxetine), work by modulating neurotransmitter levels to improve attention and reduce hyperactivity. Behavioral interventions, such as those used in the ENGAGE approach, focus on enhancing child engagement through goal-setting, which helps improve functional abilities and participation in daily activities. These treatments are crucial as they address both the neurological and behavioral aspects of the disorders, leading to better overall outcomes for patients.

New Horizons in Pediatric Psychopharmacology.An Evaluation Approach for the Performance of Dosing Regimens in Attention-Deficit/Hyperactivity Disorder Treatment.National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: changes in effectiveness and growth after the end of treatment.