Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05295472 |
Other study ID # |
2020-02655 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2021 |
Est. completion date |
June 30, 2023 |
Study information
Verified date |
December 2023 |
Source |
Karolinska Institutet |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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) 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.
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.