Trial Summary
What is the purpose of this trial?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.
Is the treatment ENGAGE a promising treatment for children with neurodevelopmental disorders?Yes, ENGAGE is a promising treatment because it focuses on setting goals that are important to both children and their families, which can help improve their rehabilitation outcomes. It also emphasizes the importance of involving caregivers in structured activities, which can enhance the development of functional skills in children with neurodevelopmental disorders.457813
What safety data exists for the treatment ENGAGE for neurodevelopmental disorders?The provided research does not directly mention safety data for the treatment ENGAGE or child-oriented goal-setting for neurodevelopmental disorders. However, it highlights the importance of pediatric safety profiling and protocol development in translational research, emphasizing the need for safety monitoring and risk management in pediatric trials. Additionally, it discusses the characteristics of pediatric adverse event reports in the FDA Adverse Event Reporting System, which could be relevant for understanding general safety concerns in pediatric treatments.126910
What data supports the idea that Child-oriented Goal-setting for Neurodevelopmental Disorders (also known as: ENGAGE) is an effective treatment?The available research shows that involving children and their families in setting goals is crucial for effective treatment. This approach helps ensure that the treatment is relevant to the child's needs and priorities. It emphasizes the importance of children being active participants in their health management, which is recognized as a key factor in successful outcomes. While specific data points are not provided, the emphasis on child and family involvement suggests that this method is effective in addressing the unique needs of children with neurodevelopmental disorders.38111214
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves children with neurodevelopmental disorders, it's likely that continuing current medications is allowed unless specified otherwise by the trial coordinators.
Eligibility Criteria
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).Exclusion Criteria
My condition is getting worse over time.
My child has had a seizure in the last 2 months.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of AlbertaEdmonton, Canada
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Who is running the clinical trial?
University of AlbertaLead Sponsor
Alberta Health servicesCollaborator
References
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]To improve the gathering of adverse events (AEs) in pediatric psychopharmacology by examining the value and acceptability of increasingly detailed elicitation methods.
Adverse life events and pediatric bipolar disorder in a community mental health setting. [2019]To determine the frequency and effects of exposure to adverse events in pediatric bipolar disorder.
Neurodevelopmental disabilities: beyond the diagnosis. [2007]Increasingly clinicians are taking more active roles in the management of children with neurodevelopmental disorders. Management of these children extends beyond traditional boundaries of health. The purpose of this review is to provide clinicians with an approach to the management of children with neurodevelopmental disorders. Patient advocacy is crucial for effective practice when working with children with neurodevelopmental disabilities. An effective advocate understands how a child's impairments relate to his/her limitations and works to prevent barriers to participation. The advocate recognizes the multiple domains in a child's health and life that must be addressed. An overall management program should be developed in cooperation with the child's primary advocates, his/her family. There are multiple different therapies, each with its own goals, that should be coordinated and prioritized as part of this plan. Federal programs can provide some of these therapies for children.
Opportunities for early intervention based on theory, basic neuroscience, and clinical science. [2021]Therapeutic approaches in the pediatric population have generally been less aggressive than those implemented for younger and older adults. Several factors contribute to this, starting with the challenge of engaging infants in the "goal" of therapy, their resistance to initiating behaviors that are uncomfortable or fatiguing, the desire to make therapy as functionally relevant as possible when many functional skills have yet to emerge, and residual history of outdated theoretical concepts. On the practical side of who will pay for this more aggressive approach, there is limited empirical evidence based on randomized controlled trials to convince third-party payers to fund more extensive services. This article outlines a theoretical perspective prominent in developmental science that argues not only for the importance of frequent bouts of functionally relevant activity on the self-organization of behavioral patterns, but also for the impact that should be expected from the use of rigorous interventions on underlying subsystems, such as neural organization, that support these outcomes. In order to propose some future opportunities for clinical research and application, examples from recent activity-based clinical studies are presented, along with theoretical principles, neuroscience, and other tissue science data concerning mechanisms that contribute to behavioral changes. One such opportunity is to increase the structured engagement of caregivers, guided by therapists, in administering well-defined activity intervention programs focused on the development of specific functional skills. Such an approach may be one of the few financially feasible options for generating sufficient therapy that adheres to principles for optimizing development of neuromotor control.
Systematic review and meta-analysis of cognitive interventions for children with central nervous system disorders and neurodevelopmental disorders. [2018]To assess the efficacy of cognitive interventions for children with neurological disorders, acquired brain injuries, and neurodevelopmental disorders.
Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project. [2018]Individual case safety reports (ICSRs) are a cornerstone in drug safety surveillance. The knowledge on using these data specifically for children is limited. We studied characteristics of pediatric ICSRs reported to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Public available ICSRs reported in children (0-18 years) to FAERS were downloaded from the FDA-website for the period Jan 2004-Dec 2011. Characteristics of these ICSRs, including the reported drugs and events, were described and stratified by age-groups. We included 106,122 pediatric ICSRs (55% boys and 58% from United States) with a median of 1 drug [range 1-3] and 1 event [1-2] per ICSR. Mean age was 9.1 years. 90% was submitted through expedited (15-days) (65%) or periodic reporting (25%) and 10% by non-manufacturers. The proportion and type of pediatric ICSRs reported were relatively stable over time. Most commonly reported drug classes by decreasing frequency were 'nervous system drugs' (58%), 'antineoplastics' (32%) and 'anti-infectives' (25%). Most commonly reported system organ classes were 'general' (13%), 'nervous system' (12%) and 'psychiatric' (11%) disorders. Duration of use could be calculated for 19.7% of the reported drugs, of which 14.5% concerned drugs being used long-term (>6 months). Knowledge on the distribution of the drug classes and events within FAERS is a key first step in developing pediatric specific methods for drug safety surveillance. Because of several differences in terms of drugs and events among age-categories, drug safety signal detection analysis in children needs to be stratified by each age group.
Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches. [2019]The efficacy of two different goal-setting approaches (children's self-identified goals and goals identified by parents) were compared on a goal-directed, task-oriented intervention.
Using child- and family-centred goal setting as an outcome measure in residential rehabilitation for children and youth with acquired brain injuries: The challenge of predicting expected levels of achievement. [2020]Collaborative, child- and family-centred goal setting is essential in paediatric, acquired brain injury (ABI) rehabilitation. This study aims to understand which goals children and families prioritize and how accurately therapists predict expected levels of achievement for these goals.
Adverse drug event-related hospitalisation in persons with neurodevelopmental disorders: a state-wide retrospective cohort study. [2020]Little is known about the sociodemographic and clinical characteristics of adverse drug events (ADEs) in patients with neurodevelopmental disorders (NDD).
Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. [2021]Translational paediatric drug development includes the exchange between basic, clinical and population-based research to improve the health of children. This includes the assessment of treatment related risks and their management. The objectives of this scoping review were to search and summarise the literature for practical guidance on how to establish a paediatric safety specification and its integration into a paediatric protocol. PubMed, Embase, Web of Science, and websites of regulatory authorities and learned societies were searched (up to 31 December 2020). Retrieved citations were screened and full texts reviewed where applicable. A total of 3480 publications were retrieved. No article was identified providing practical guidance. An introduction to the practical aspects of paediatric safety profiling and protocol development is provided by combining health authority and learned society guidelines with the specifics of paediatric research. The paediatric safety specification informs paediatric protocol development by, for example, highlighting the need for a pharmacokinetic study prior to a paediatric trial. It also informs safety related protocol sections such as exclusion criteria, safety monitoring and risk management. In conclusion, safety related protocol sections require an understanding of the paediatric safety specification. Safety data from carefully planned paediatric research provide valuable information for children, parents and healthcare providers.
Capturing Meaningful Outcomes in -Pediatric Neurology: Further Reflections on Principles, Challenges, and Opportunities. [2022]Patient and public involvement in health care is considered indispensable in the way we conduct daily pediatric neurology practice, and in the development and utilization of health outcome measurements. This essay examines what meaningful quality evaluations and measurements are, describes the development of approaches to measuring health and outcomes, explores the potential applications of patient-reported outcome measures in pediatric neurology, and identifies opportunities and challenges in using patient-reported outcome measurements in our daily clinical practice. Recent developments have transformed our attitude on how to help children with neurological and developmental conditions and their families: specifically, (1) the recognition of the fundamental rights of children with disabilities; (2) the application of the framework of the International Classification of Functioning, Disability and Health by the World Health Organization that views health from the perspective of both biopsychosocial strengths and functional abilities; (3) the application of qualitative research methodologies to children with neurological conditions and their caregivers to elucidate what they consider essential for their own good health and well-being; and (4) the development of core outcome measurements sets for children and adults with various neurological and developmental conditions. In summary, supporting patients in their role as full partners in clinical care and research enables them to contribute their experiential knowledge and helps ensure that results are relevant and address patient needs, preferences, and priorities. Recognizing the importance of involving young people in their health management decisions has become central in contemporary medicine and needs to be part of the curriculum of all health care professionals.
Agreement between parents' and clinical researchers' ratings of behavioral problems in children with fragile X syndrome and chromosome 15 imprinting disorders. [2022]Despite the increasing number of clinical trials involving children with neurodevelopmental disorders, appropriate and objective outcome measures for behavioral symptoms are still required.
A Narrative Review of Function-Focused Measures for Children With Neurodevelopmental Disorders. [2022]Clinical measures in health and rehabilitation settings are often used to examine child functioning to better support the diverse needs of children with neurodevelopmental disorders (NDD) and their families. The WHO's International Classification of Functioning, Disability, and Health (ICF) framework reflects a focus of health beyond biomedical deficits, using the concept of functioning to create opportunities for measurement development involving this construct. In the measures developed in the field of childhood NDD, it is unclear whether and how these tools measure and incorporate the ICF framework and its domains within health care contexts. Understanding how these measures utilize the ICF will enable researchers and clinicians to operationalize function-focused concepts in studies and clinical practice more effectively. This narrative review aims to identify and describe function-focused measures that are based on the ICF for children with NDD, as described in the peer-reviewed literature. This review used a systematic search strategy with multiple health-focused databases (Medline, PsycInfo, EMBASE, EMCARE), and identified 14 clinical measures that provide direct support for children (aged 0-21) with NDD in pediatric health (and other) settings. Results described the measures that were primarily developed for three main diagnostic populations [cerebral palsy, autism spectrum disorder, and communication disorders]; had varying contextual use (clinical-only or multiple settings); and for which authors had conducted psychometric tests in the measure's initial development studies, with the most common being content validity, interrater reliability, test-retest reliability. Participation (79%, n = 11) & Activities (71%, n = 10) were the most common ICF domains captured by the set of measurement tools. Overall (71%, n = 10) of the identified measures utilized multiple ICF domains, indicating that the "dynamic nature" of the interactions of the ICF domains was generally evident, and that this result differentiated from "linking rules," commonly used in research and clinical practice. The implications of these findings suggest that clinical measures can be an effective application of the ICF's defined concepts of functioning for children with NDD.
Meaningful outcomes for children and their caregivers attending a paediatric brain centre. [2023]To identify meaningful outcomes of children and their caregivers attending a paediatric brain centre.