Developmental Language DisorderNCT05295472
Reading Intervention to Children With Developmental Language Disorder
A study testing Grapholearn, Vector and Usual schooling in people with Developmental Language Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Language Disorder
- What is being tested?
- Grapholearn, Vector and Usual schooling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2021to 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DLD diagnoses
- attending a special school for children with DLD
- attending Swedish schoolgrades 0 to 4
Who cannot join
- non-Swedish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Reading Intervention to Children With Developmental Language Disorder
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.
Read more
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.
Read the detailed description
(I) The investigators will collect the following cognitive measures from each participant with DLD: Decoding of words and nonwords, and words occurring in the Grapholearn computer game; naming of the letters in the Swedish alphabet; non-verbal IQ; articulation; grammar production; nonword repetition; verbal working memory; and general language ability. The tasks assessing reading decoding skills are administered at T1, T2, and T3, while all other tests are administered only at baseline. The test administrators are blinded for group (intervention or control groups).
(II) Anamnestic interviews with the participants' parents aiming at collecting information about the child (diagnoses or developmental challenges); reading activities in the family; family aggregation of language-related diagnoses and problems in the parents and siblings, and highest level of education of each parent, as well as their current occupation.
(III) Language and reading tests of parents, same reading tests as in (I); and tests of nonword repetition, grammatical production of past tense; and sentence repetition.
(IV) Questionnaire to the schools covering type and dose of formal reading instruction, and who is providing this instruction (e.g., teacher or special teacher) and in what kind of context (individual, whole class, and/or in small groups of children).
The investigators will perform analysis of primary and secondary outcomes and influence of background factors in a mixed linear model with time- and groupinteraction effects. Background factors will be presented with relevant descriptive statistics, such as mean and standard deviations.
- Conditions
- Developmental Language Disorder
- Being tested
- Grapholearn, Vector, Usual schooling
- Keywords
- reading intervention
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrapholearnBehavioural
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.
VectorBehavioural
A computer game focusing on children's development of mathematic skills
Usual schoolingBehavioural
No GL or Math computer games, only the usual schooling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Usual schooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The letter naming task is used to measure the rate of correct naming of 26 lower case letters. The task is presented with a chart of 4 by 6 rows of letters with the Times New Roman font in size 48 pt.
Measured: 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)
Rate of correct (number) decoding at word level (words and nonwords) over time.
Measured: At baseline compared to directly after the 5 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Aug 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelli Kalnak, Karolinska Institutet
- Investigators
- Nelli Kalnak, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295472
- Sponsor's protocol ID
- 2020-02655
- Status last verified
- Dec 2023
- First submitted
- 28 Feb 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Reading Intervention to Children With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT05295472
- Acronym / sponsor ID
- 2020-02655
- Conditions
- Developmental Language Disorder
- Keywords
- reading intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Mar 2022 (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 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.
Detailed description
(I) The investigators will collect the following cognitive measures from each participant with DLD: Decoding of words and nonwords, and words occurring in the Grapholearn computer game; naming of the letters in the Swedish alphabet; non-verbal IQ; articulation; grammar production; nonword repetition; verbal working memory; and general language ability. The tasks assessing reading decoding skills are administered at T1, T2, and T3, while all other tests are administered only at baseline. The test administrators are blinded for group (intervention or control groups).
(II) Anamnestic interviews with the participants' parents aiming at collecting information about the child (diagnoses or developmental challenges); reading activities in the family; family aggregation of language-related diagnoses and problems in the parents and siblings, and highest level of education of each parent, as well as their current occupation.
(III) Language and reading tests of parents, same reading tests as in (I); and tests of nonword repetition, grammatical production of past tense; and sentence repetition.
(IV) Questionnaire to the schools covering type and dose of formal reading instruction, and who is providing this instruction (e.g., teacher or special teacher) and in what kind of context (individual, whole class, and/or in small groups of children).
The investigators will perform analysis of primary and secondary outcomes and influence of background factors in a mixed linear model with time- and groupinteraction effects. Background factors will be presented with relevant descriptive statistics, such as mean and standard deviations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grapholearn group | Experimental | Behavioral: GrapholearnChildren 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. |
| Math game group | Active comparator | Behavioral: VectorChildren 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. |
| Usual schooling | Active comparator | Behavioral: Usual schoolingChildren 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- DLD diagnoses
- attending a special school for children with DLD
- attending Swedish schoolgrades 0 to 4
Key exclusion criteria (1 listed)
- non-Swedish speaking
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 |
|---|---|---|
| GrapholearnGL 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. | Behavioural | Grapholearn group |
| VectorA computer game focusing on children's development of mathematic skills | Behavioural | Math game group |
| Usual schoolingNo GL or Math computer games, only the usual schooling | Behavioural | Usual schooling |
Primary outcome
Change of performance on the Grapholearn-based decoding task (Abrahamsson and Quick, 2015)
Time frame: At baseline compared to directly after the 5 weeks of intervention.
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.
2 secondary outcomes
Change of performance on the Letter Namning Task (Frylmark, 1995) based on the Swedish alphabet.
Time frame: 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)
Time frame: At baseline compared to directly after the 5 weeks of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
Nelli Kalnak, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grapholearn, Vector and Usual schooling in people with Developmental Language Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 18 Dec 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of performance on the Grapholearn-based decoding task (Abrahamsson and Quick, 2015) (time frame: At baseline compared to directly after the 5 weeks of intervention.). 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 18 Dec 2025.