protocolSection identificationModule nctId: NCT06277440, orgStudyIdInfo id: NSTC 112-2314-B-341-001, briefTitle: Cognitive Training for Attention Deficit Hyperactivity Disorder and Developmental Delays, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Attention Deficit Hyperactivity Disorders, conditions: Developmental Delays, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcome measurements will be performed by a researcher who is blind to the groups' allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: cognitive training, interventions name: active control, outcomesModule primaryOutcomes measure: Changes of executive function, secondaryOutcomes measure: changes of symptoms of attention deficit hyperactivity disorder, secondaryOutcomes measure: changes of attention, secondaryOutcomes measure: Changes of sensory integration, secondaryOutcomes measure: changes of intelligence, secondaryOutcomes measure: changes of functional performance, secondaryOutcomes measure: Changes of family impact, secondaryOutcomes measure: Changes of quality of life, secondaryOutcomes measure: Changes in performance activity in kindergarten, otherOutcomes measure: changes of brain network connectivity, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Shin Kong Wu Ho-Su Memorial Hospital, city: Taipei, zip: 111-01, country: Taiwan, contacts name: Ru-Lan Hsieh, MD, role: CONTACT, phone: 886-2-28332211, phoneExt: 2538, email: rulanhsieh@gmail.com, contacts name: Ru-Lan Hsieh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False