Cognitive Training Effects for Preschool Children With Attention Deficit Hyperactivity Disorder and Developmental Delays
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Taipei Medical University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes of executive function
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome measurements will be performed by a researcher who is blind to the groups' allocation.
Eligibility Criteria
- Ages
- 4 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Traditional rehabilitation program with additional cognitive training
Intervention: cognitive training (Other)
Active Control
Traditional rehabilitation programs without additional cognitive training
Intervention: active control (Other)
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 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)
- Changes of family impact(score change from baseline to 12 weeks of treatment, higher score, the better outcome)