- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295472
Reading Intervention to Children With Developmental Language Disorder
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nelli Kalnak, PhD
- Phone Number: 0724 - 67 18 15
- Email: nelli.kalnak@ki.se
Study Contact Backup
- Name: Kristiina Tammimies, PhD
- Email: kristiina.tammimies@ki.se
Study Locations
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-
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Stockholm, Sweden, 117 77
- Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- DLD diagnoses
- attending a special school for children with DLD
- attending Swedish schoolgrades 0 to 4
Exclusion Criteria:
- non-Swedish speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grapholearn group
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.
|
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.
|
Active Comparator: Math game group
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.
|
A computer game focusing on children's development of mathematic skills
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Active Comparator: Usual schooling
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.
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No GL or Math computer games, only the usual schooling
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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At baseline compared to directly after the 5 weeks of intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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At baseline compared to directly after the 5 weeks of intervention.
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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.
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Rate of correct (number) decoding at word level (words and nonwords) over time.
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At baseline compared to directly after the 5 weeks of intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nelli Kalnak, PhD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-02655
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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