Reading Intervention to Children With Developmental Language Disorder

December 12, 2023 updated by: Nelli Kalnak, Karolinska Institutet

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

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

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Stockholm, Sweden, 117 77
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
No GL or Math computer games, only the usual schooling

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.
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 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.
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.
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.
Rate of correct (number) decoding at word level (words and nonwords) over time.
At baseline compared to directly after the 5 weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nelli Kalnak, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Developmental Language Disorder

Clinical Trials on Grapholearn

3
Subscribe