Skip to main content
Clinical Trials/NCT06277440
NCT06277440
Not Yet Recruiting
N/A

Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays

Taipei Medical University1 site in 1 country20 target enrollmentMarch 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorders
Sponsor
Taipei Medical University
Enrollment
20
Locations
1
Primary Endpoint
Changes of executive function
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

To explore whether children with Attention Deficit Hyperactivity Disorder and developmental delays who receive cognitive training and conventional rehabilitation can improve executive function more than traditional rehabilitation alone. A magnetoencephalographic examination will be arranged to explore how brain network activation works.

Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated.

Detailed Description

Research method: 20 preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under rehabilitation therapy will be collected. They will be randomly assigned to the experimental group (receiving rehabilitation therapy and three times per week for 15 minutes, a total of 12 weeks of interactive cognitive training) and the control group (receiving rehabilitation therapy only). Therapeutic effects will be evaluated, including Sensory Profile, Swanson, Nolan and Pelham version IV, Conners Kiddie Continuous Performance test, Chinese Childhood Executive Functioning Inventory, and Chinese version of Wechsler Intelligence Scale for Children-IV; and physical health conditions, including Pediatric Daily Occupation Scale, Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form, Pediatric Quality of Life Inventory (PedsQL)will be evaluated by an investigator who is blinded to the group's allocation at before treatment and after 12 weeks of treatment. All participants will be investigated by magnetoencephalography (MEG) to identify the brain network connectivity while performing different tasks before and after 12 weeks of treatment. Brain Magnetic Resonance Imaging will be performed for brain mapping. Possible results: The study will shed light on therapeutic effects and brain network connectivity by cognitive training for preschool children with Attention Deficit Hyperactivity Disorder and developmental delays.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater

Exclusion Criteria

  • age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70

Outcomes

Primary Outcomes

Changes of executive function

Time Frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome

Changes in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome

Secondary Outcomes

  • Changes of family impact(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • changes of symptoms of attention deficit hyperactivity disorder(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • Changes of sensory integration(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • Changes in performance activity in kindergarten(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • changes of attention(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • changes of functional performance(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • changes of intelligence(score change from baseline to 12 weeks of treatment, higher score, the better outcome)
  • Changes of quality of life(score change from baseline to 12 weeks of treatment, higher score, the better outcome)

Study Sites (1)

Loading locations...

Similar Trials