ENGAGE for Neurodevelopmental Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta, Edmonton, Canada
Neurodevelopmental Disorders
ENGAGE - Procedure
Eligibility
< 18
All Sexes
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Study Summary

This study is evaluating whether a goal-setting approach can improve outcomes for children with disabilities.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether ENGAGE will improve 2 primary outcomes, 4 secondary outcomes, and 6 other outcomes in patients with Neurodevelopmental Disorders. Measurement will happen over the course of Change from baseline (pre-treatment) to post-treatment (within 10 days), and change between post-treatment and 3-months post-treatment.

At each treatment session (session frequency will vary; estimated # of sessions is 3-10. )
Child engagement in therapy
Baseline
Mastery Motivation
Parenting style
Day 10
Autonomy
Child Quality of Life
Functional Abilities
Parent Quality of Life
Participation
Day 10
Self-perceived, goal-related performance
Self-perceived, goal-related performance on the COPM (COPM-P)
baseline
Perceived Competence
post-treatment (within 10 days)
Child-rated experience measure of practitioner empathy

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual Care Group (Control)
1 of 2
Intervention Group (ENGAGE)
1 of 2
Active Control
Experimental Treatment

This trial requires 96 total participants across 2 different treatment groups

This trial involves 2 different treatments. ENGAGE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Group (ENGAGE)
Procedure
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.
Usual Care Group (Control)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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline for reporting.

Closest Location

University of Alberta - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

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Patient Q&A Section

How serious can neurodevelopmental disorders be?

"The development of interventions that target specific psychosocial barriers of adolescents with NDs would allow children with NDs to have the best opportunity for growth and personal, social, and occupational development." - Anonymous Online Contributor

Unverified Answer

Does engage improve quality of life for those with neurodevelopmental disorders?

"Those who were enrolled from 3-5 years of age were more satisfied with enrollment in the Engage study than were those enrolled from 6-8 years of age." - Anonymous Online Contributor

Unverified Answer

How many people get neurodevelopmental disorders a year in the United States?

"6.2 million children and 20 million adults have been diagnosed with autism. 15.8 million adults in the United States already have an ASD, and this number will almost double over the next 40years. The prevalence of ASD is 2.9 per 1,000. This prevalence suggests that approximately 19.5 million individuals have ASD in the United States. There are several neurodevelopmental disorders—and autism spectrum disorders in particular—that do not share common causes. There is no widely agreed upon single explanation for all neurodevelopmental disorders. But it is plausible to assume that some share common causal factors shared by all neurodevelopmental disorders and that this can help pinpoint other possible causes of neurodevelopmental disorders." - Anonymous Online Contributor

Unverified Answer

What is neurodevelopmental disorders?

"Neurodevelopmental disorders may be broadly defined as disorders of brain structure, function or cellular organization, all characterized by long-term, complex, often multisystemic, and often neuroplastic effects. These phenomena can be studied by functional imaging, and neurobehavioral assessment including both qualitative and quantitative assessment of behavior, and cognitive functioning." - Anonymous Online Contributor

Unverified Answer

What causes neurodevelopmental disorders?

"The causes of neurodevelopmental disorders are numerous with no single cause being identified. All of the factors described above can contribute to neurodevelopmental disorders. Research is not yet capable of pointing out a single cause of neurodevelopmental disorder. But there is strong evidence that a mixture of multiple factors contribute to the development of a neurodevelopmental disorder and this may explain the occurrence of different types of neurodevelopmental disorders." - Anonymous Online Contributor

Unverified Answer

Can neurodevelopmental disorders be cured?

"Though our team and most other clinicians do not believe they are curable for a NDD, we believe there are a few specific circumstances under which the patient could benefit from a combination of therapy and a high levels of care. Specific and in depth clinical trials with [power] are required to determine the efficacy of therapies that could aid individuals in managing NDD." - Anonymous Online Contributor

Unverified Answer

What are the signs of neurodevelopmental disorders?

"Although many signs and symptoms differ in each individual, certain features can be useful in recognizing common neurodevelopmental disorders such as autism, Fragile X syndrome, attention-deficit hyperactivity disorder (ADHD), and Down syndrome." - Anonymous Online Contributor

Unverified Answer

What are common treatments for neurodevelopmental disorders?

"Medication and behaviour therapy may be used to treat intellectual disabilities. Rehabilitation of children with communication disorders, autism spectrum disorders and behavioural and mood disorders is often needed and is more complicated.\nRelated works\n\n1. Bijlkamp, L. M. (2008). Introduction to Clinical Practice of Psychology. New York. Basic Books, Inc.\n2. Buss, R. D. (1989). Adult Education: An Introduction to the Principles. New York, NY, USA. Teachers College Press.\n3. Fonagy, P., & Shattuck, M. W. (2009). How to Think About Psychoanalysis." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in engage for therapeutic use?

"In recent years, a number of medications have emerged that show promise in the treatment of various behavioral and neurological disorders including schizophrenia, autism and attention-deficit / attention-deficit hyperactivity disorder. The ability to engage patients in appropriate and therapeutic use of medications is an important part of clinical care, and clinicians must learn the appropriate selection and use of these drugs to achieve optimal results. Therapeutic use of medications often requires careful consideration of many factors including the type of medication, dose and duration of use, as well as patient preferences, side effects and coexisting conditions. There is also an emerging need for the development of pharmacogenetic markers for therapeutic indications of which can be used to more appropriately tailor therapeutic drug use to individual patients." - Anonymous Online Contributor

Unverified Answer

What does engage usually treat?

"This population, at a very low risk in terms of developmental disorders, may be an appropriate population for early pharmacogenomic screening/testing studies of genetic factors that may guide developmental treatment. The next step was to apply these findings to future clinical investigations." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating neurodevelopmental disorders?

"Since the 1950s, a great deal has been discovered about brain development and neurodevelopmental disorders, with many new treatments developed and tested on a case-by-case basis in the treatment of specific neurodevelopmental disorders. There is still so much that remains to be discovered about neurodevelopmental disorders, but many advances have been made in the treatment of them. The research has shown the benefits from early intervention and appropriate therapies if not undertaken too many months or years before the start of these disorders." - Anonymous Online Contributor

Unverified Answer

How does engage work?

"Parents must take advantage of the benefits of engagement in order to enhance their children's progress. The quality of the learning environment determines the type of progress made on one's own and one's children." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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