An interventional study of cognitive training and active control in Attention Deficit Hyperactivity Disorders and Developmental Delays, sponsored by Taipei Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 20 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
Traditional rehabilitation program with additional cognitive training
Other: cognitive training
Traditional rehabilitation programs without additional cognitive training
Other: active control
cognitive training, 15 min, three times per week, for 12 weeks
Also known as: traditional rehabilitation programs
Traditional rehabilitation programs
Also known as: traditional rehabilitation programs
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
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
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
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of attention
Changes in scores assessed by Conners Kiddie Continous Performance Test, range from 0-100, higher scores indicate a worse outcome
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: score change from baseline to 12 weeks of treatment, higher score, the better outcome
changes of brain network connectivity
Changes of brain network connectivity assessed by magnetoencephalography, range from 0-1, higher scores indicate a better outcome
Time frame: connectivity change from baseline to 12 weeks of treatment, higher score, the better outcome
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Sep 2024, 6 months later.
Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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