Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT06950866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1.Chinese version of Swan-son Nolan and Pelham, Version IV Scale-parent form (SNAP-IV)', 'timeFrame': 'Baseline, 1 month after intervention, 2 months after intervention', 'description': "This questionnaire is used to evaluate the children's ADHD symptoms."}, {'measure': '2.Behavior Rating Inventory of Executive Function (BRIEF)', 'timeFrame': 'Baseline, 1 month after intervention, 2 months after intervention', 'description': "This questionnaire is used to evaluate the children's executive function."}, {'measure': '3.Parenting Stress Index-Short Form (PSI-SF)', 'timeFrame': 'Baseline, 1 month after intervention, 2 months after intervention', 'description': "This questionnaire is used to evaluate the parents' parenting stress."}], 'secondaryOutcomes': [{'measure': '4.Client Satisfaction Questionnaire (CSQ)', 'timeFrame': 'Baseline, 1 month after intervention, 2 months after intervention', 'description': "This questionnaire is used to evaluate the parents' satisfaction with the intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Attention Deficit Hyperactivity Disorder (ADHD)', 'Executive function training'], 'conditions': ['Attention Deficit Hyperactivity Disorder (ADHD)']}, 'descriptionModule': {'briefSummary': "This study aims to investigate the effectiveness of a home-based executive function training Intervention on children's ADHD symptoms, executive function and parents' parenting stress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.SNAP-IV scale, inattention or hyperactivity-impulsivity scale score \\> 1.2\n* 2.Parents who could understand or lacking of access to computers and the Internet\n* 3.Parents can commit to ensuring full participation and complete the training and test evaluations in full compliance with the researcher's requirements\n* 4.Children and their parents consent to the study\n\nExclusion Criteria:\n\n* 1.Children or parents with severe organic encephalopathy and other severe mental disorders\n* 2.Parents or children are receiving ADHD-related behavioral treatment\n* 3.Parents or children who dropped out before the study started or in the middle of the study"}, 'identificationModule': {'nctId': 'NCT06950866', 'briefTitle': 'Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Mental Health Centre'}, 'officialTitle': 'Home-Based Executive Function Training Intervention For Attention-Deficit/ Hyperactivity Disorder-prone Children', 'orgStudyIdInfo': {'id': 'KY2024.0710.15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Behavioral: Home-based executive function training therapy']}, {'type': 'OTHER', 'label': 'Waitlist group', 'interventionNames': ['Behavioral: Home-based executive function training therapy']}], 'interventions': [{'name': 'Home-based executive function training therapy', 'type': 'BEHAVIORAL', 'description': 'Parents receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.', 'armGroupLabels': ['Intervention group']}, {'name': 'Home-based executive function training therapy', 'type': 'BEHAVIORAL', 'description': 'After the postintervention data collection, parents in the waitlist group receive a 2-week, 20-session online child executive function training program, delivered by a systematically trained and supervised therapist.', 'armGroupLabels': ['Waitlist group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Mental Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}