Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays
- Conditions
- Attention Deficit Hyperactivity DisordersDevelopmental Delays
- Interventions
- Other: cognitive trainingOther: active control
- Registration Number
- NCT06277440
- Lead Sponsor
- Taipei Medical University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- preschool children with Attention Deficit Hyperactivity Disorder and developmental delays under regular rehabilitation programs intelligence quotient 70 or greater
- age less than 4 or greater than 6 metal in teeth intelligence quotient less than 70
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group cognitive training Traditional rehabilitation program with additional cognitive training Active Control active control Traditional rehabilitation programs without additional cognitive training
- Primary Outcome Measures
Name Time Method Changes of executive function 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 Outcome Measures
Name Time Method Changes of family impact score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Child Health Questionaire, parent form 28, range from 0-100, higher scores indicate a 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 in scores assessed by Swanson, Nolan and Pelham questionnaire, range from 0 to 54, higher scores indicate a worse outcome
Changes of sensory integration score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Sensory Profile, range from 0-100, higher scores indicate a better outcome
Changes in performance activity in kindergarten score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Kindergarten Performance Activity, range from 0-100, higher scores indicate a worse outcome
changes of attention score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Conners Kiddie Continous Performance Test, range from 0-100, higher scores indicate a worse outcome
changes of functional performance score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Pediatric Outcome Data Collection Instrument, range from 0-100, higher scores indicate a better outcome
changes of intelligence score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by the Wechsler Intelligence Scale of children, the average score is 100, with a higher score indicating higher intelligence and a lower score indicating a lower level of intelligence.
Changes of quality of life score change from baseline to 12 weeks of treatment, higher score, the better outcome Changes in scores assessed by Pediatric Quality of Life Inventory, range from 0-100, higher scores indicate a better outcome
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan