96 Participants Needed

Child-oriented Goal-setting for Neurodevelopmental Disorders

LP
SH
Overseen BySandra Hodgetts, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.611121314

Who Is on the Research Team?

LP

Lesley Pritchard, PhD

Principal Investigator

University of Alberta

SH

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group (ENGAGE)Experimental Treatment1 Intervention
Group II: Usual Care Group (Control)Active Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Meaningful outcomes for children and their caregivers attending a paediatric brain centre. [2023]
Agreement between parents' and clinical researchers' ratings of behavioral problems in children with fragile X syndrome and chromosome 15 imprinting disorders. [2022]
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]
Neurodevelopmental disabilities: beyond the diagnosis. [2007]
Capturing Meaningful Outcomes in -Pediatric Neurology: Further Reflections on Principles, Challenges, and Opportunities. [2022]
Adverse drug event-related hospitalisation in persons with neurodevelopmental disorders: a state-wide retrospective cohort study. [2020]
Adverse life events and pediatric bipolar disorder in a community mental health setting. [2019]
Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]
Pediatric Drug Safety Surveillance in FDA-AERS: A Description of Adverse Events from GRiP Project. [2018]
Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review. [2021]
A Narrative Review of Function-Focused Measures for Children With Neurodevelopmental Disorders. [2022]
12.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Opportunities for early intervention based on theory, basic neuroscience, and clinical science. [2021]
Can children identify and achieve goals for intervention? A randomized trial comparing two goal-setting approaches. [2019]
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