NCT05709418

Brief Summary

The aim of this study is to investigate the effect of an intervention program for low-performing first graders in mathematics. .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 12, 2023

Last Update Submit

January 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 weeks

Secondary Outcomes (1)

  • Word problem solving from Wechsler Intelligence Scale for Children - Fifth Edition

    10 weeks

Other Outcomes (2)

  • Non-verbal IQ Raven

    10 weeks

  • Vocubulary from Wechsler Intelligence Scale for Children - Fifth Edition

    10 weeks

Study Arms (2)

Mathematics intervention

EXPERIMENTAL

Low-performing children get targeted support with a scripted intervention

Behavioral: Intensiv support for first graders in Norway

Control group

NO INTERVENTION

Business as usual

Interventions

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

Mathematics intervention

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • not proficient Norwegian language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold University College

Halden, Norway

Location

MeSH Terms

Conditions

Dyscalculia

Condition Hierarchy (Ancestors)

Specific Learning DisorderLearning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Anita Lopez-Pedersen, Phd

    Østfold University College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

August 15, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations