NCT05295472

Brief Summary

The main purpose of this study is to investigate if the internet-based computer-game Grapholearn (GL) is an effective tool for early and intensive intervention of the reading decoding skills in Swedish children with DLD, as compared to two control groups of children with DLD (I) playing a math computer game, and (II) attending usual schooling. Hypothesis: Five weeks of 20 sessions of GL will improve the accuracy of word and nonword decoding skills in children with DLD from baseline to T2 and T3. The GL intervention group will perform higher number of accuratly decoded words and nonwords than the two control groups at T2, and at T3. The second aim is to elucidate how the parents' language and reading skills, prevalence of language-related diagnoses, and socio-economic-status, and the children's self-reported self-esteem is related to their reading skills. Hypothesis 1: Children with DLD who's parents show poor language and/or reading skills will perform lower on the word/nonword decoding tests. Hypothesis 2: Children who show no significant improvement of word/nonword decoding skills will to a higher degree have parents with reading difficulties. Hypothesis 3: Parents highest level of education will not be associated with the participating childrens language and reading skills. Hypothesis 4: Results from the self-reported self-esteem will be lower than normdata from the test manual, and will not be associated with the children's language and reading skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
1.3 years 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

December 18, 2025

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

February 28, 2022

Last Update Submit

December 11, 2025

Conditions

Keywords

reading intervention

Outcome Measures

Primary Outcomes (1)

  • Change of performance on the Grapholearn-based decoding task (Abrahamsson and Quick, 2015)

    The rate (number) of accurate decoding of words and nonwords measured with lists of real words (n=20), grapholearn-words (n=20) and nonword (n=20) consisting of two-, three-, four-, and five-letter words distributed in three word lists, short words with simple orthographic structure first and long words with complex orthographic structure last.

    At baseline compared to directly after the 5 weeks of intervention.

Secondary Outcomes (2)

  • Change of performance on the Letter Namning Task (Frylmark, 1995) based on the Swedish alphabet.

    At baseline compared to directly after the 5 weeks of intervention.

  • Change of performace on the Swedish version of TOWRE (Test of Word Reading Efficiency)

    At baseline compared to directly after the 5 weeks of intervention.

Study Arms (3)

Grapholearn group

EXPERIMENTAL

Children with DLD who attend a special school for children with DLD. This group will play the computer game GL in school for 5 weeks, 20 sessions, 15-30 min per session. Supervised by a teacher.

Behavioral: Grapholearn

Math game group

ACTIVE COMPARATOR

Children with DLD who attend a special school for children with DLD. This group will play a computer game focusing on math in school for 5 weeks, 20 sessions, 15-30 min per session. Supervised by a teacher.

Behavioral: Vector

Usual schooling

ACTIVE COMPARATOR

Children with DLD who attend a special school for children with DLD. This children will have normal schooling as usual without playing any of the above computer games.

Behavioral: Usual schooling

Interventions

GrapholearnBEHAVIORAL

GL is a computer game based on the phonics-method (i.e., graphem-phoneme correspondence). It was developed at Jyväskylä University in Finland, in several languages, among others also for Swedish.

Grapholearn group
VectorBEHAVIORAL

A computer game focusing on children's development of mathematic skills

Math game group
Usual schoolingBEHAVIORAL

No GL or Math computer games, only the usual schooling

Usual schooling

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • DLD diagnoses
  • attending a special school for children with DLD
  • attending Swedish schoolgrades 0 to 4

You may not qualify if:

  • \- non-Swedish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 117 77, Sweden

Location

MeSH Terms

Conditions

Language Development Disorders

Interventions

Disease Vectors

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disease Transmission, InfectiousPublic HealthEnvironment and Public HealthChain of InfectionEpidemiologic Methods

Study Officials

  • Nelli Kalnak, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 25, 2022

Study Start

August 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

December 18, 2025

Record last verified: 2023-12

Locations