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 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.

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.

Is the child-oriented goal-setting treatment for neurodevelopmental disorders safe for children?

The research articles do not provide specific safety data for the child-oriented goal-setting treatment or its variations like ENGAGE. However, general pediatric drug safety surveillance shows that adverse events are monitored and reported, which helps in understanding and managing risks in treatments for children. ^{1 2 3 4 5}

How does the ENGAGE treatment differ from other treatments for neurodevelopmental disorders?

The ENGAGE treatment is unique because it focuses on child-oriented goal-setting, involving children and their families in setting and achieving personalized goals, which is different from traditional approaches that may not prioritize individual goal-setting. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment ENGAGE for neurodevelopmental disorders?

The research highlights the importance of involving children and families in setting goals for treatment, which is a key part of the ENGAGE approach. This collaborative goal-setting has been shown to be effective in other areas, like rehabilitation for brain injuries, suggesting it could also be beneficial for neurodevelopmental disorders. ^{6 11 12 13 14}

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

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]

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]

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]

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]

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 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 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]

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 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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Meaningful outcomes for children and their caregivers attending a paediatric brain centre. [2023]

2. United States 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. [2022]

3. England 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Neurodevelopmental disabilities: beyond the diagnosis. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Adverse drug event-related hospitalisation in persons with neurodevelopmental disorders: a state-wide retrospective cohort study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse life events and pediatric bipolar disorder in a community mental health setting. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project. [2018]

10. Switzerland 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. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Narrative Review of Function-Focused Measures for Children With Neurodevelopmental Disorders. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of cognitive interventions for children with central nervous system disorders and neurodevelopmental disorders. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

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

14. England pubmed.ncbi.nlm.nih.gov

Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches. [2019]