Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05709418
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2023-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervention for Low-performing First Graders in Mathematics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-13', 'releaseDate': '2023-08-23'}], 'estimatedResultsFirstSubmitDate': '2023-08-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D060705', 'term': 'Dyscalculia'}], 'ancestors': [{'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Non-verbal IQ Raven', 'timeFrame': '10 weeks', 'description': "Raven's colored matrices. Minimum score 0, maximum 36. Higher score indicates better result."}, {'measure': 'Vocubulary from Wechsler Intelligence Scale for Children - Fifth Edition', 'timeFrame': '10 weeks', 'description': 'Vocabulary assessment. Minimum score 0, maximum 54. Higher score indicates better result.'}], 'primaryOutcomes': [{'measure': 'Number knowledge', 'timeFrame': '10 weeks', 'description': 'Number knowledge measured by digit comparison, number reading and number recognition (numerical knowledge) - both orally and written presented. Higher score indicates better result.'}, {'measure': 'Arithmetic fluency 1-10 with Test of Basic Arithmetic and Numeracy, the Norwegian test called Arithmetic fact-test and a digital test created by University of Oslo.', 'timeFrame': '10 weeks', 'description': 'Arithmetic fluency in the number area 1-10. Higher score indicates better result.'}], 'secondaryOutcomes': [{'measure': 'Word problem solving from Wechsler Intelligence Scale for Children - Fifth Edition', 'timeFrame': '10 weeks', 'description': 'Word problem solving presented orally. Minimum score 0, maximum 34. Higher score indicates better result.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mathematics Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .', 'detailedDescription': 'There were sent a request to a school in the central of East-Norway to participate. The principal answered yes, and then asked the teachers at first grade if they would like to participate. The teachers were positive to the study, and therefore the students and parents were asked to participate. It was total 74 students and 54 of them accepted to participate in the study. The inclusion criteria of the study is that the participants talks and understand Norwegian approximate fluently. In this study that means one participant was excluded.\n\nThe study will use a design of randomized control trial (RCT) where the population of 53 students will be doing av screening-test. After the screening 20% of the lowest-performance will make up the sample and they will be departed in a clinical-group and a control-group. These students will then be tested with Test of Basic Arithmetic and Numeracy, the Norwegian test called Arithmetic fact-test, the vocabulary and calculation tasks from Wechsler Intelligence Scale for Children - Fifth Edition and Ravens colored progressive matrices. The randomization will be conduct using randomize.org and the parents will get information about which group their child will participate in. The intervention are eight week long with 4 lessons per week. Each lesson are about 45-50 minutes long. The start of the intervention will be in week 42, 2022 and end in week 49, 2022. The intervention-group will follow an intervention conducting elements from an education program called "ThinkMath" and self-developed tasks. The control-group will follow ordinary classroom-lessons. After ended intervention-period the students will be tested with the same test-battery as were used in front of the start point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Performing under the cut off score of a screening tool for first graders, i.e. 20th percentile\n\n\\-\n\nExclusion Criteria:\n\n* not proficient Norwegian language skills'}, 'identificationModule': {'nctId': 'NCT05709418', 'briefTitle': 'Intervention for Low-performing First Graders in Mathematics', 'organization': {'class': 'OTHER', 'fullName': 'Ostfold University College'}, 'officialTitle': 'Intensiv støtte i Matematikk for Elever Som er i Risiko for å Utvikle Matematikkvansker', 'orgStudyIdInfo': {'id': 'OstfoldUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mathematics intervention', 'description': 'Low-performing children get targeted support with a scripted intervention', 'interventionNames': ['Behavioral: Intensiv support for first graders in Norway']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Business as usual'}], 'interventions': [{'name': 'Intensiv support for first graders in Norway', 'type': 'BEHAVIORAL', 'description': 'Intervention targeting early numeracy skills that are known to be important for mathematical development, focusing on counting skills, counting strategies, number knowledge, word problem solving and basic understanding of addition and subtraction', 'armGroupLabels': ['Mathematics intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halden', 'country': 'Norway', 'facility': 'Østfold University College', 'geoPoint': {'lat': 59.12478, 'lon': 11.38754}}], 'overallOfficials': [{'name': 'Anita Lopez-Pedersen, Phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Østfold University College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ostfold University College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-08-23', 'type': 'RELEASE'}, {'date': '2024-03-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ostfold University College'}}}}