Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-16 @ 7:38 PM
Study NCT ID:
NCT01462032
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2011-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2011-09-13', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment', 'timeFrame': 'Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)', 'description': "This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker."}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment', 'timeFrame': 'Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset)', 'description': 'These are parent and teacher ratings of ADHD symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preschool Children', 'ADHD', 'Treatment', 'Non-pharmacological'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '31834588', 'type': 'DERIVED', 'citation': "Halperin JM, Marks DJ, Chacko A, Bedard AC, O'Neill S, Curchack-Lichtin J, Bourchtein E, Berwid OG. Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD. J Abnorm Child Psychol. 2020 Mar;48(3):375-389. doi: 10.1007/s10802-019-00610-w."}]}, 'descriptionModule': {'briefSummary': "This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.\n\nBoth interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.", 'detailedDescription': 'Children eligible for this study are:\n\n* 4 and 5 years-old (between the ages of 48 - 72 months)\n* shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD\n* enrolled in a preschool or daycare setting\n\nChildren are ineligible to participate in this study if they:\n\n* are currently being treated with psychotropic medication\n* have a diagnosed neurological disorder\n* have an autism spectrum pr pervasive developmental disorder\n* are intellectually impaired\n* are highly physically aggressive'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '48 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child is hyperactive\n* Child meets criteria for ADHD\n* Child attends preschool or kindergarten\n* Family speaks English at home\n\nExclusion Criteria:\n\n* Family does not speak English at home\n* Child does not attend preschool/kindergarten\n* Child is diagnosed with or suspected of having PDD\n* Child has IQ of less than 80\n* Child is being treated with psychotropic medication\n* Child has a diagnosed neurological disorder\n* Child is aggressive\n* Child is only inattentive and does not exhibit signs of hyperactivity\n* Parent has attended parent management classes\n* Child is not physically able to participate in group play sessions'}, 'identificationModule': {'nctId': 'NCT01462032', 'acronym': 'NIPA', 'briefTitle': 'Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'Queens College, The City University of New York'}, 'officialTitle': 'Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies', 'orgStudyIdInfo': {'id': '4R33MH085898-03', 'link': 'https://reporter.nih.gov/quickSearch/4R33MH085898-03', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive enhancing games', 'description': 'Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.', 'interventionNames': ['Behavioral: Training Executive, Attention and Motor Skills (TEAMS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Parent support and education', 'description': 'Parents will participate in groups designed to provide information about ADHD and support for working with their child.', 'interventionNames': ['Behavioral: Parent support and education']}], 'interventions': [{'name': 'Training Executive, Attention and Motor Skills (TEAMS)', 'type': 'BEHAVIORAL', 'description': 'Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home', 'armGroupLabels': ['Cognitive enhancing games']}, {'name': 'Parent support and education', 'type': 'BEHAVIORAL', 'description': 'Parents will participate in groups designed to provide information about ADHD and support for working with their child.', 'armGroupLabels': ['Parent support and education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11367', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'Queens College, City University of New York', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}], 'overallOfficials': [{'name': 'Jeffrey M Halperin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queens College, CUNY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queens College, The City University of New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor of Psychology', 'investigatorFullName': 'Jeffrey Halperin', 'investigatorAffiliation': 'Queens College, The City University of New York'}}}}