protocolSection identificationModule nctId: NCT06369714, orgStudyIdInfo id: CHEC2023-296, briefTitle: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children., acronym: ADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-24, primaryCompletionDateStruct date: 2025-02-24, completionDateStruct date: 2025-02-24, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Lei Lei, MD, class: OTHER, descriptionModule briefSummary: A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens., conditionsModule conditions: Attention Deficit Disorder With Hyperactivity, conditions: Executive Function Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Concerta, interventions name: Digital therapeutics, outcomesModule primaryOutcomes measure: Swanson, Nolan, and Pelham IV Rating Scale, secondaryOutcomes measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD, secondaryOutcomes measure: Questionnaire-Children with Difficulties, secondaryOutcomes measure: Behavior Rating Inventory of Executive Function, secondaryOutcomes measure: Continuous Performance Test, secondaryOutcomes measure: Digital Cancellation Test, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Changzheng Hospital, Naval Medical University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200003, country: China, contacts name: Yujiao Wang, MBBS, role: CONTACT, phone: 15021500051, email: 2191916146@qq.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Changhai Hospital, Naval Medical University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Yuanhao Cai, MBBS, role: CONTACT, phone: 15001969690, email: 15552283399@163.com, contacts name: Yuanhao Cai, MBBS, role: SUB_INVESTIGATOR, contacts name: Lei Lei, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False