Mathematics DisorderNCT05709418
Intervention for Low-performing First Graders in Mathematics
A study testing Intensiv support for first graders in Norway in people with Mathematics Disorder, run by Ostfold University College at 1 site in Norway.
Trial summary
The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. . Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Mathematics Disorder
- What is being tested?
- Intensiv support for first graders in Norway
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- not proficient Norwegian language skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensiv støtte i Matematikk for Elever Som er i Risiko for å Utvikle Matematikkvansker
The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .
Read the 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.
- Conditions
- Mathematics Disorder
- Being tested
- Intensiv support for first graders in Norway
- Medical subject headings
- Dyscalculia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensiv support for first graders in NorwayBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Mathematics intervention | Experimental | Low-performing children get targeted support with a scripted intervention Receives: Behavioral: Intensiv support for first graders in Norway |
| Control group | No intervention | Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number knowledge
Number knowledge measured by digit comparison, number reading and number recognition (numerical knowledge) - both orally and written presented. Higher score indicates better result.
Measured: 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.
Arithmetic fluency in the number area 1-10. Higher score indicates better result.
Measured: 10 weeks
Secondary outcomes (1)
Word problem solving from Wechsler Intelligence Scale for Children - Fifth Edition
Word problem solving presented orally. Minimum score 0, maximum 34. Higher score indicates better result.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mathematics DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Lopez-Pedersen, Phd, Study chair, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709418
- Sponsor's protocol ID
- OstfoldUC
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensiv støtte i Matematikk for Elever Som er i Risiko for å Utvikle Matematikkvansker
- ClinicalTrials.gov ID
- NCT05709418
- Acronym / sponsor ID
- OstfoldUC
- Conditions
- Mathematics Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mathematics intervention | Experimental | Behavioral: Intensiv support for first graders in NorwayLow-performing children get targeted support with a scripted intervention |
| Control group | No intervention | –Business as usual |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- not proficient Norwegian language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensiv support for first graders in NorwayIntervention 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 | Behavioural | Mathematics intervention |
Primary outcome
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.
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.
1 secondary outcome
Word problem solving from Wechsler Intelligence Scale for Children - Fifth Edition
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Lopez-Pedersen, Phd study chair
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensiv support for first graders in Norway in people with Mathematics Disorder, run by Ostfold University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number knowledge (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.