Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT04528433
Status:
WITHDRAWN
Last Update Posted:
2022-03-22
First Post:
2020-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The medical treatment of participants will be given by a doctor who does not know the study group of the patient. The investigator of the primary outcome and secondary outcome will also be unaware of the grouping of the patient. One psychiatrist blind of grouping will ask parents about the ADHD symptom of their children and rate it with SNAP-IV score.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study will be carried out using a parallel randomized study design. Each participant will be randomly assigned either to the collaborated intervention or to the routine clinical care control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2020-08-23', 'studyFirstSubmitQcDate': '2020-08-23', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total score change in SNAP-IV scale', 'timeFrame': 'Baseline, 3 months after enrollment', 'description': 'It is a repeated measurement. The Swanson, Nolan, and Pelham Questionnaire (SNAP-IV) Rating Scale is a revised version of the Swanson, Nolan and Pelham (SNAP) Questionnaire that utilizes the DSM-IV criteria for ADHD and oppositional defiant disorder, rated by caregiver or professionals. It comprises three subscales: Inattention, Hyperactivity/Impulsivity, and Oppositional Defiant Disorder. The score of each item is rated with a 4-point Likert scale (0 = not at all, 3 = very much). We choose the total score ofInattention and Hyperactivity/Impulsivityfor the evaluation of change in ADHD symptom in children. The score is calculated by adding all the items inthe two subscales. The change of score is calculated by score at 3 months enrollment minus score at baseline (enrollment).'}], 'secondaryOutcomes': [{'measure': 'total score change in Behavior Rating Inventory of Executive Function scale', 'timeFrame': 'Baseline, 3 months after enrollment', 'description': "It is a repeated measurement. The Behavior Rating Inventory of Executive Function(BRIEF) Scale reflects the performance of children's deficits in executive function in daily life, which covers a number of organizational skills involved in organizational skills training. We choose the total score ofBRIEF for the evaluation of change in organizational skills in children. The score is calculated by the published recording chart. The change of score is calculated by score at 3 months enrollment minus score at baseline (enrollment)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with ADHD\n* Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score\\>12\n* Full-Scale Intelligence Quotient\\>=80 (Wechsler intelligence scale for children-IV)\n\nExclusion Criteria:\n\n* Accepting any type of psychological treatment during the intervention\n* Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk\n* Attending any other clinical research at the same time'}, 'identificationModule': {'nctId': 'NCT04528433', 'briefTitle': 'A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With Attention Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'xlklmy01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medical-education-community Collaborated Intervention', 'interventionNames': ['Behavioral: Medical-education-community Collaborated Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'routine clinical care', 'interventionNames': ['Behavioral: routine clinical care']}], 'interventions': [{'name': 'Medical-education-community Collaborated Intervention', 'type': 'BEHAVIORAL', 'description': 'The Medical-education-community Collaborated Intervention adds an additional part in comparison with the control group of classroom management guidance for teachers, review and practice organizational skills based on school daily activities in the school, teacher rewards and encouragement of students.', 'armGroupLabels': ['Medical-education-community Collaborated Intervention']}, {'name': 'routine clinical care', 'type': 'BEHAVIORAL', 'description': 'Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.', 'armGroupLabels': ['routine clinical care']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mengyao Li, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Department of Psychological Medicine, Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}