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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Traditional rehabilitation program with additional cognitive training |
|
| Active Control | Other | Traditional rehabilitation programs without additional cognitive training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive training | Other | cognitive training, 15 min, three times per week, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of executive function | Changes in scores assessed by the Taiwanese Traditional Chinese Childhood Executive Functioning Inventory range from 1 to 5, higher scores indicate a worse outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| Measure | Description | Time Frame |
|---|---|---|
| changes of symptoms of attention deficit hyperactivity disorder | Changes in scores assessed by Swanson, Nolan and Pelham questionnaire, range from 0 to 54, higher scores indicate a worse outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| changes of attention |
| Measure | Description | Time Frame |
|---|---|---|
| changes of brain network connectivity | Changes of brain network connectivity assessed by magnetoencephalography, range from 0-1, higher scores indicate a better outcome | connectivity change from baseline to 12 weeks of treatment, higher score, the better outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh, MD, MD | Contact | 886-2-28332211 | 2538, 2531 | M001052@ms.skh.org.tw |
| Ru-Lan Hsieh, MD, MD | Contact | rulanhsieh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh, MD | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D003147 | Communication Disorders |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Twenty 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 by an investigator blinded to the group's allocation before and after 12 weeks of treatment.
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Outcome measurements will be performed by a researcher who is blind to the groups' allocation.
| active control | Other | Traditional rehabilitation programs |
|
|
Changes in scores assessed by Conners Kiddie Continous Performance Test, range from 0-100, higher scores indicate a worse outcome |
| score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| Changes of sensory integration | Changes in scores assessed by Sensory Profile, range from 0-100, higher scores indicate a better outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| changes of intelligence | 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. | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| changes of functional performance | Changes in scores assessed by Pediatric Outcome Data Collection Instrument, range from 0-100, higher scores indicate a better outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| Changes of family impact | Changes in scores assessed by Child Health Questionaire, parent form 28, range from 0-100, higher scores indicate a better outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| Changes of quality of life | Changes in scores assessed by Pediatric Quality of Life Inventory, range from 0-100, higher scores indicate a better outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| Changes in performance activity in kindergarten | Changes in scores assessed by Kindergarten Performance Activity, range from 0-100, higher scores indicate a worse outcome | score change from baseline to 12 weeks of treatment, higher score, the better outcome |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |