Child-oriented Goal-setting for Neurodevelopmental Disorders

Recruiting in Palo Alto (17 mi)

Overseen by Sandra Hodgetts, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Disqualifiers: Progressive condition, Uncontrolled seizures

No Placebo Group

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{3 11 12 13 14}

Research Team

Lesley Pritchard, PhD

Principal Investigator

University of Alberta

Sandra Hodgetts, PhD

Principal Investigator

University of Alberta

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).

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.

Trial Timeline

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

Treatment Details

Interventions

• ENGAGE (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Edmonton, Canada

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Patients Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Patients Recruited

658,000+

Findings from Research

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

References

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]