- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05709418
Intervention for Low-performing First Graders in Mathematics
Intensiv støtte i Matematikk for Elever Som er i Risiko for å Utvikle Matematikkvansker
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Halden, Norway
- Østfold University College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Performing under the cut off score of a screening tool for first graders, i.e. 20th percentile
-
Exclusion Criteria:
- not proficient Norwegian language skills
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Mathematics intervention
Low-performing children get targeted support with a scripted intervention
|
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
|
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NO_INTERVENTION: Control group
Business as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number knowledge
Time Frame: 10 weeks
|
Number knowledge measured by digit comparison, number reading and number recognition (numerical knowledge) - both orally and written presented.
Higher score indicates better result.
|
10 weeks
|
|
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.
Time Frame: 10 weeks
|
Arithmetic fluency in the number area 1-10.
Higher score indicates better result.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Word problem solving from Wechsler Intelligence Scale for Children - Fifth Edition
Time Frame: 10 weeks
|
Word problem solving presented orally.
Minimum score 0, maximum 34.
Higher score indicates better result.
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-verbal IQ Raven
Time Frame: 10 weeks
|
Raven's colored matrices.
Minimum score 0, maximum 36.
Higher score indicates better result.
|
10 weeks
|
|
Vocubulary from Wechsler Intelligence Scale for Children - Fifth Edition
Time Frame: 10 weeks
|
Vocabulary assessment.
Minimum score 0, maximum 54.
Higher score indicates better result.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anita Lopez-Pedersen, Phd, Østfold University College
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OstfoldUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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