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Reading Intervention to Children With Developmental Language Disorder

Primary Purpose

Developmental Language Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Grapholearn
Vector
Usual schooling
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Language Disorder focused on measuring reading intervention

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- non-Swedish speaking

Sites / Locations

  • Karolinska InstitutetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Grapholearn group

Math game group

Usual schooling

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 28, 2022
Last Updated
March 16, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT05295472
Brief Title
Reading Intervention to Children With Developmental Language Disorder
Official Title
Randomized Control Reading Intervention to Children With Developmental Language Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Language Disorder
Keywords
reading intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grapholearn group
Arm Type
Experimental
Arm Description
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.
Arm Title
Math game group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual schooling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grapholearn
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vector
Intervention Description
A computer game focusing on children's development of mathematic skills
Intervention Type
Behavioral
Intervention Name(s)
Usual schooling
Intervention Description
No GL or Math computer games, only the usual schooling
Primary Outcome Measure Information:
Title
Change of performance on the Grapholearn-based decoding task (Abrahamsson and Quick, 2015)
Description
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.
Time Frame
At baseline compared to directly after the 5 weeks of intervention.
Secondary Outcome Measure Information:
Title
Change of performance on the Letter Namning Task (Frylmark, 1995) based on the Swedish alphabet.
Description
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.
Time Frame
At baseline compared to directly after the 5 weeks of intervention.
Title
Change of performace on the Swedish version of TOWRE (Test of Word Reading Efficiency)
Description
Rate of correct (number) decoding at word level (words and nonwords) over time.
Time Frame
At baseline compared to directly after the 5 weeks of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DLD diagnoses attending a special school for children with DLD attending Swedish schoolgrades 0 to 4 Exclusion Criteria: - non-Swedish speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nelli Kalnak, PhD
Phone
0724 - 67 18 15
Email
Nelli.Kalnak@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kristiina Tammimies, PhD
Email
Kristiina.Tammimies@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelli Kalnak, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
117 77
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelli Kalnak, PhD
Phone
0724 - 67 18 15
Email
nelli.kalnak@ki.se
First Name & Middle Initial & Last Name & Degree
Kristiina Tammimies, PhD
Email
kristiina.tammimies@ki.se

12. IPD Sharing Statement

Learn more about this trial

Reading Intervention to Children With Developmental Language Disorder

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