Child-oriented Goal-setting for Neurodevelopmental Disorders

Overseen By Sandra Hodgetts, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Progressive condition, Uncontrolled seizures

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2-8 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called ENGAGE, which helps children with neurodevelopmental disabilities set personal goals during therapy. The researchers aim to determine if this method improves participation in daily activities and overall quality of life. The trial compares ENGAGE to usual therapy to identify which is more effective and cost-efficient. Children aged 5-12 who are already receiving physical or occupational therapy and speak English may be suitable candidates. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their therapy experience and contribute to innovative research.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.

What prior data suggests that the ENGAGE approach is safe for children with neurodevelopmental disorders?

Research shows that the ENGAGE approach, a method focused on setting goals for children, lacks specific safety data. However, as it involves goal-setting rather than medication or surgery, it is generally considered low-risk for kids. Studies of similar goal-setting methods have found no harmful effects.

Labeling the study "Not Applicable" in terms of phase indicates it is not testing a new drug or invasive treatment, suggesting minimal risk for participants. Additionally, since this approach is used in therapy sessions without involving physical procedures, it is likely well-tolerated by children with neurodevelopmental disorders.

Overall, despite the absence of direct safety data, the nature of the ENGAGE approach suggests it is safe and unlikely to cause problems for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "ENGAGE" intervention because it introduces a child-centered goal-setting approach for neurodevelopmental disorders, which is quite different from the usual care methods that often lack personalized goal-setting. This approach is unique because it pairs therapists with children to create specific, individualized goals using a principles-based strategy, ensuring that the treatment is tailored to each child's needs. By focusing on personalized goals, ENGAGE aims to create more effective and meaningful outcomes for children, potentially leading to better engagement and progress in therapy.

What evidence suggests that the ENGAGE approach is effective for neurodevelopmental disorders?

Research has shown that child-focused goal-setting methods, like ENGAGE, can greatly improve therapy results for children with neurodevelopmental disorders. In this trial, participants in the intervention group will receive the ENGAGE method, which involves children in setting their own goals to boost motivation and involvement in therapy. This approach can lead to better skills and participation in everyday activities. It not only increases the child's satisfaction with their progress but also enhances the overall quality of life for both the children and their families. Early results suggest that the ENGAGE method might be more cost-effective and efficient than traditional therapy methods. Overall, the ENGAGE approach appears promising for making children's rehabilitation more meaningful and effective. ^{1 6 7 8 9}

Who Is on the Research Team?

Lesley Pritchard, PhD

Principal Investigator

University of Alberta

Sandra Hodgetts, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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).

Inclusion Criteria

English speaking

I have been referred for physical or occupational therapy.

Exclusion Criteria

My condition is getting worse over time.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. Treatment block lengths vary from 3-8 sessions over 2-8 weeks.

2-8 weeks

3-8 sessions

Post-treatment Assessment

Assessments are conducted to evaluate changes in goal-related performance, functional abilities, and quality of life.

Within 10 days post-treatment

Follow-up

Participants are monitored for sustained effects on goal-related performance, functional abilities, and quality of life.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ENGAGE

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group (ENGAGE) Experimental Treatment 1 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 Control 1 Intervention

The control group will comprise usual care.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

Pediatric therapeutic approaches are often less aggressive than those for adults due to challenges in engaging infants and a lack of empirical evidence to support funding for more intensive services.

The article suggests that structured caregiver involvement in activity-based interventions can enhance the development of functional skills in children, potentially improving neuromotor control and overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities for early intervention based on theory, basic neuroscience, and clinical science. Ulrich, BD.[2021]

In a study involving 34 children with disabilities, both self-identified goals by children and parent-identified goals led to significant improvements in goal attainment after an 8-week intervention, showing that children can effectively set their own goals.

There was no significant difference in goal achievement between the two approaches, indicating that allowing children to choose their own goals is just as effective as having parents set them, and these gains were maintained at a 5-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches. Vroland-Nordstrand, K., Eliasson, AC., Jacobsson, H., et al.[2019]

A study of 2173 patients with neurodevelopmental disorders (NDD) revealed that hospitalizations due to adverse drug events (ADEs) doubled over a 14-year period, highlighting a significant safety concern for this population.

Patients with NDD were found to be younger and more socio-economically disadvantaged compared to those without NDD, and they experienced more challenges in acute hospital care, indicating a need for specialized healthcare programs to address their unique needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug event-related hospitalisation in persons with neurodevelopmental disorders: a state-wide retrospective cohort study. Zhou, M., Du, W., Salvador-Carulla, L., et al.[2020]

In a study of 66 youths with bipolar disorder, over half (53%) had experienced maltreatment, indicating that adverse events are common in this population.

Exposure to these adverse events was linked to significant negative outcomes, including delays in diagnosis, increased psychiatric hospitalizations, and poorer treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse life events and pediatric bipolar disorder in a community mental health setting. Marchand, WR., Wirth, L., Simon, C.[2019]

The scoping review aimed to find practical guidance for establishing a pediatric safety specification in drug development but found no existing articles on the topic, highlighting a gap in the literature.

The review emphasizes that a well-defined pediatric safety specification is crucial for developing protocols that ensure safety monitoring, risk management, and appropriate pharmacokinetic studies in pediatric trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. Aurich, B., Jacqz-Aigrain, E.[2021]

A study involving children with brain-related disorders and their caregivers identified 27 meaningful outcomes that are important for health and functioning, including emotional well-being, quality of life, and physical health.

The research highlighted the significance of caregiver concerns and environmental factors, which were not previously emphasized in professional literature, suggesting that these should be included in future outcome assessments for children with neurodisabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaningful outcomes for children and their caregivers attending a paediatric brain centre. Heydenrijk-Kikkert, MA., Schmidt, AKK., Pangalila, R., et al.[2023]

Cognitive interventions for children with neurological and neurodevelopmental disorders showed significant positive effects in areas like attention, working memory, and memory tasks, based on a review of 13 randomized controlled trials.

Despite these positive findings, the overall quality of evidence was rated very low, indicating uncertainty about the effectiveness of these interventions across different outcome domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of cognitive interventions for children with central nervous system disorders and neurodevelopmental disorders. Robinson, KE., Kaizar, E., Catroppa, C., et al.[2018]

In a study of 122 children with severe acquired brain injury, families prioritized goals related to mobility, self-care, and communication during rehabilitation, highlighting the importance of child- and family-centered goal setting.

Therapists accurately predicted the expected levels of achievement for only 46% of the goals set, indicating a significant challenge in setting realistic outcomes, which families should be aware of during discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kelly, G., Dunford, C., Forsyth, R., et al.[2020]

In a study of 123 children with neurodevelopmental disorders, including fragile X syndrome and chromosome 15 imprinting disorders, there was a notable disagreement between parents' and researchers' ratings of behavioral problem severity, indicating a need for more objective measures.

The inter-rater agreement varied significantly across different behavioral domains, with moderate agreement for hyperactivity (ICC = 0.48) but only slight to fair agreement for other behaviors like self-injury and tantrums, suggesting that a multi-informant approach may be necessary for accurate assessments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agreement between parents' and clinical researchers' ratings of behavioral problems in children with fragile X syndrome and chromosome 15 imprinting disorders. Arpone, M., Bretherton, L., Amor, DJ., et al.[2022]

Involving patients and their families in pediatric neurology is crucial for developing effective health outcome measurements and ensuring that care is relevant to their needs and preferences.

Recent advancements emphasize the rights of children with disabilities and the importance of using frameworks like the International Classification of Functioning to assess health from a holistic perspective, which includes both strengths and functional abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capturing Meaningful Outcomes in -Pediatric Neurology: Further Reflections on Principles, Challenges, and Opportunities. Ronen, GM.[2022]

A systematic review identified 14 clinical measures designed to support children with neurodevelopmental disorders (NDD), showing that most of these tools effectively incorporate the WHO's ICF framework, particularly focusing on the domains of Participation and Activities.

The majority of these measures (71%) utilized multiple ICF domains, highlighting the dynamic interactions of functioning concepts, which can enhance the understanding and support of children with NDD in clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review of Function-Focused Measures for Children With Neurodevelopmental Disorders. Shanmugarajah, K., Rosenbaum, P., Zubairi, M., et al.[2022]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

A study of 106,122 individual case safety reports (ICSRs) for pediatric patients (0-18 years) submitted to the FDA from 2004 to 2011 revealed that 'nervous system drugs' were the most commonly reported, highlighting the need for focused safety monitoring in this category.

The analysis showed significant differences in reported drug classes and adverse events across different age groups, suggesting that drug safety evaluations for children should be tailored to specific age categories to improve signal detection and safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project. de Bie, S., Ferrajolo, C., Straus, SM., et al.[2018]

Clinicians are increasingly involved in the comprehensive management of children with neurodevelopmental disorders, emphasizing the importance of patient advocacy to address barriers to participation in various life domains.

An effective management program should be collaboratively developed with the child's family and include coordinated therapies tailored to the child's specific needs, with potential support from federal programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurodevelopmental disabilities: beyond the diagnosis. Accardo, J., Shapiro, BK.[2007]

Citations

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Child-oriented Goal-setting for Neurodevelopmental Disorders The research articles do not provide specific safety data for the child-oriented goal-setting treatment or its variations like ENGAGE. However, general ...

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Evaluation of Effectiveness of Child-oriented Goal-setting ... This pragmatic trial aims to improve health outcomes for children with neurodevelopmental disabilities (NDD) using a novel therapist-targeted, theory-driven, ...

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Child-Oriented Goal-Setting for Pediatric Rehabilitation This N/A medical study run by University of Alberta is evaluating whether ENGAGE approach (child-oriented goal-setting) will have tolerable side effects ...

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Neurodevelopmental delay: Case definition & guidelines for ... Case definitions and guidelines for data collection, analysis, and presentation for neurodevelopmental delay as an adverse event following immunization.