Intellectual DisabilitiesNCT05709405
Reading Intervention for Children With Intellectual Disabilities Who Require Augmentative and Alternative Communication
A study testing Reading intervention in people with Intellectual Disabilities, run by Ostfold University College at 2 sites in Norway.
Trial summary
The goal of this multiple single case study with multiple randomized baseline (with four starting points and 18 measurements across time) is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC). Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disabilities
- What is being tested?
- Reading intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Sep 2022to 18 Dec 2024
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students between 6 and 14
- Students who are diagnosed with intellectual disabilities
- Students who do not have a functional speech, i.e. require augmentative and alternative communication (AAC) to understand and/or make oneself understood.
- Students must use AAC as their primary form of communication
- Students cannot follow ordinary curricula (LK20) but have their own education plan.
Who cannot join
- Students younger than six years and older than 14 years
- Students who have not been diagnosed within intellectual disabilities
- Students who have a functional speech and do not require AAC
- Students who follow ordinary education
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
University of South-Eastern Norway
Borre, Vestfold, 3199
Østfold University College
Halden, BRA Veien, 1757
About this study
Official title: Reading Instruction for Children With Intellectual Disabilites Who Require Augmentative and Alternative Communication: a Multiple Random Baselines Design
The goal of this multiple single case study with multiple randomized baseline (with four starting points and 18 measurements across time) is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC).
The main questions to answer are:
Read more
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and increased accuracy of sound blending by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Lesing for alle) and improved acquisition of letter sound correspondence by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of phoneme segmentation by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of recognition of sight words by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of decoding by students age 6-14 with intellectual disabilities who require AAC?
- Is there a positive and strong correlation between increasing skills from 1-3 and 4-5? Meaning, is there a transfer from lower level skills (phonological skills) to decoding skills?
The participants (age 6-14) will receive daily instruction in a reading material that follows all the strategies of Accessible Literacy Learning, developed by Janice Light and David McNaughton. It is the teachers who will carry out the teaching in the students fixed and familiar place at school. The reading material consist of tasks in sound blending, letter-sound correspondence, phoneme segmentation, sight words and decoding. The reading material will use explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. The intervention will take place for a total of 18 months.
Read the detailed description
The acquisition of reading skills is a critical need for all individuals and allow fuller participations in education and employment and gives access to personal expression, social media and enjoyable leisure pursuits. Individuals with intellectual disabilities who require augmentative and alternative communication (AAC) often face challenges in that they are met with too low expectations and low ambitions. There is also a lack of evidence-based reading programs and reading materials adapted for individuals who require AAC.
This study will conduct a reading intervention for children with intellectual disabilities who require augmentative and alternative communication (AAC). Through the reading intervention, students will work with components such as sound blending, letter-sound correspondence, phoneme segmentation, sight words, shared reading and decoding. It will be used components of effective evidence-based literacy intervention such as explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. All the instructional activities have been adapted, oral/spoken responses are not required, and the students can use alternative methods, such as signs, pointing at symbols or pointing with their eyes.
The aim of this study is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC) to see if the students can acquire functional reading skills. Even simple reading skills can contribute to major changes in the individual's quality of life and to a greater independence in communication with the environment.
- Conditions
- Intellectual Disabilities
- Being tested
- Reading intervention
- Keywords
- Intellectual disabilities, AAC, Reading intervention, Sound blending, Letter-sound correspondence, Phoneme segmentation, Shared reading, Sight words, Decoding
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading interventionOther
The intervention will use a reading program called "Lesing for alle" (Reading for all) based on the research of Accessible Literacy Learning (ALL) which is an evidence-based approach, designed to teach reading skills to students with various intellectual disabilities, including autism spectrum disorders
| Study group | Role | What they receive |
|---|---|---|
| Reading Intervention | Experimental | The reading material is made based on the research of Professor Janice Light and Professor David McNaughton at Penn State University. The reading material "Lesing for alle" (Reading for all) contains all the principles, strategies, and methods that form the basis of Accessible Literacy Learning (ALL). The intervention is conducted by trained teachers, in a place known to the students. The material contains: tasks in sound blending, letter-sound correspondence, phoneme- segmentation, sight words, single-word decoding, and shared reading.
Due to the multiple single baseline design, each participant will be regarded as being in the control condition, and then will be randonly assigned to four different baselines starting the intervention individually after the 2nd, 3rd, 4th, and 5th month. Receives: Other: Reading intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sound-blending trajectory change
Testing in sound blending involves testing the student's ability to combine individual sounds into words. The students will see a sheet of paper with four symbols. In the instructions, the target word will be presented by expanding the individual sound in the word.
Measured: Every month, for 18 months
Letter-sound correspondence trajectory change
Tests the student's ability to associate letter-sounds with corresponding letters. The students must discriminate between 4 symbols, and the instruction is, for example: point to "0".
Measured: Every month, for 18 months
Phoneme segmentation trajectory change
The students are measured on their ability to find the first sound in words. In the test, there must be discrimination between 4 symbols, and students must identify the word that begins with, for example, the sound "m".
Measured: Every month, for 18 months
Secondary outcomes (2)
Sight-words change
Tests the students ability to recognize words they have learned by sight.
Measured: Three time points before, during, and after intervention (months 1, 12 and 18)
Decoding change
Tests the students ability to convert the printed code (letters) of traditional ortography into words in order to derive meaning.
Measured: Three time points before, during and after intervention (months 1, 12 and 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Sep 2022
- Primary completion15 Oct 2024 (estimated)
- Study completion18 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilitiesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple random baseline design
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of South-Eastern Norway, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Kenneth Larsen, Phd, Study director, University of South-Eastern Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709405
- Sponsor's protocol ID
- 988724
- Status last verified
- Aug 2024
- First submitted
- 10 Jan 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulriksen LB, Bilet-Mossige M, Moreira HC, Larsen K, Nordahl-Hansen A. Reading intervention for students with intellectual disabilities without functional speech who require augmentative and alternative communication: a multiple single-case design with four randomized baselines. Trials. 2023 Jun 27;24(1):433. doi: 10.1186/s13063-023-07452-4.
PubMed 37370125
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Instruction for Children With Intellectual Disabilites Who Require Augmentative and Alternative Communication: a Multiple Random Baselines Design
- ClinicalTrials.gov ID
- NCT05709405
- Acronym / sponsor ID
- 988724
- Conditions
- Intellectual Disabilities
- Keywords
- Intellectual disabilities, AAC, Reading intervention, Sound blending, Letter-sound correspondence, Phoneme segmentation, Shared reading, Sight words
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- University of South-Eastern Norway, The Research Council of Norway
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 18 Dec 2024 (estimated)
- First posted
- 2 Feb 2023 (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 goal of this multiple single case study with multiple randomized baseline (with four starting points and 18 measurements across time) is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC).
The main questions to answer are:
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and increased accuracy of sound blending by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Lesing for alle) and improved acquisition of letter sound correspondence by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of phoneme segmentation by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of recognition of sight words by students age 6-14 with intellectual disabilities who require AAC?
- Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of decoding by students age 6-14 with intellectual disabilities who require AAC?
- Is there a positive and strong correlation between increasing skills from 1-3 and 4-5? Meaning, is there a transfer from lower level skills (phonological skills) to decoding skills?
The participants (age 6-14) will receive daily instruction in a reading material that follows all the strategies of Accessible Literacy Learning, developed by Janice Light and David McNaughton. It is the teachers who will carry out the teaching in the students fixed and familiar place at school. The reading material consist of tasks in sound blending, letter-sound correspondence, phoneme segmentation, sight words and decoding. The reading material will use explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. The intervention will take place for a total of 18 months.
Detailed description
The acquisition of reading skills is a critical need for all individuals and allow fuller participations in education and employment and gives access to personal expression, social media and enjoyable leisure pursuits. Individuals with intellectual disabilities who require augmentative and alternative communication (AAC) often face challenges in that they are met with too low expectations and low ambitions. There is also a lack of evidence-based reading programs and reading materials adapted for individuals who require AAC.
This study will conduct a reading intervention for children with intellectual disabilities who require augmentative and alternative communication (AAC). Through the reading intervention, students will work with components such as sound blending, letter-sound correspondence, phoneme segmentation, sight words, shared reading and decoding. It will be used components of effective evidence-based literacy intervention such as explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. All the instructional activities have been adapted, oral/spoken responses are not required, and the students can use alternative methods, such as signs, pointing at symbols or pointing with their eyes.
The aim of this study is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC) to see if the students can acquire functional reading skills. Even simple reading skills can contribute to major changes in the individual's quality of life and to a greater independence in communication with the environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple random baseline design
| Arm | Type | Receives |
|---|---|---|
| Reading Intervention | Experimental | Other: Reading interventionThe reading material is made based on the research of Professor Janice Light and Professor David McNaughton at Penn State University. The reading material "Lesing for alle" (Reading for all) contains all the principles, strategies, and methods that form the basis of Accessible Literacy Learning (ALL). The intervention is conducted by trained teachers, in a place known to the students. The material contains: tasks in sound blending, letter-sound correspondence, phoneme- segmentation, sight words, single-word decoding, and shared reading. Due to the multiple single baseline design, each participant will be regarded as being in the control condition, and then will be randonly assigned to four different baselines starting the intervention individually after the 2nd, 3rd, 4th, and 5th month. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Students between 6 and 14
- Students who are diagnosed with intellectual disabilities
- Students who do not have a functional speech, i.e. require augmentative and alternative communication (AAC) to understand and/or make oneself understood.
- Students must use AAC as their primary form of communication
- Students cannot follow ordinary curricula (LK20) but have their own education plan.
Key exclusion criteria (4 listed)
- Students younger than six years and older than 14 years
- Students who have not been diagnosed within intellectual disabilities
- Students who have a functional speech and do not require AAC
- Students who follow ordinary education
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 |
|---|---|---|
| Reading interventionThe intervention will use a reading program called "Lesing for alle" (Reading for all) based on the research of Accessible Literacy Learning (ALL) which is an evidence-based approach, designed to teach reading skills to students with various intellectual disabilities, including autism spectrum disorders | Other | Reading Intervention |
Primary outcome
Sound-blending trajectory change
Time frame: Every month, for 18 months
Testing in sound blending involves testing the student's ability to combine individual sounds into words. The students will see a sheet of paper with four symbols. In the instructions, the target word will be presented by expanding the individual sound in the word.
Letter-sound correspondence trajectory change
Time frame: Every month, for 18 months
Tests the student's ability to associate letter-sounds with corresponding letters. The students must discriminate between 4 symbols, and the instruction is, for example: point to "0".
Phoneme segmentation trajectory change
Time frame: Every month, for 18 months
The students are measured on their ability to find the first sound in words. In the test, there must be discrimination between 4 symbols, and students must identify the word that begins with, for example, the sound "m".
2 secondary outcomes
Sight-words change
Time frame: Three time points before, during, and after intervention (months 1, 12 and 18)
Decoding change
Time frame: Three time points before, during and after intervention (months 1, 12 and 18)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 37370125Ulriksen LB, Bilet-Mossige M, Moreira HC, Larsen K, Nordahl-Hansen A. Reading intervention for students with intellectual disabilities without functional speech who require augmentative and alternative communication: a multiple single-case design with four randomized baselines. Trials. 2023 Jun 27;24(1):433. doi: 10.1186/s13063-023-07452-4.
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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.
Kenneth Larsen, Phd study director
University of South-Eastern Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading intervention in people with Intellectual Disabilities, run by Ostfold University College at 2 sites in Norway.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Results are not available in the source record.
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?
Sound-blending trajectory change (time frame: Every month, for 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709405, which also lists 1 linked publication.
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 9 Aug 2024.