EducationNCT07116200
Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication
A study testing Early Literacy Intervention in Kindergarten and Literacy Intervention in First Grade in people with Education, run by Ostfold University College at 1 site in Norway.
Trial summary
The goal of this 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative… Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Education
- What is being tested?
- Early Literacy Intervention in Kindergarten and Literacy Intervention in First Grade
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitations service or currently undergoing such an evaluation
- ages 4-8 (the last year in kindergarten)
- lack of functional speech and must use augmentative and alternative communication as the primary form of communication
- have a (designated) special education kindergarten teacher
Who cannot join
- having a severe visual or hearing impairment
- children who can decode syllables or words
- children with severe physical disabilities prevent the children from being able to answer with their fingers, unless they can respond with eye pointing or signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication: A Randomized Controlled Trial
The goal of this 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative communication. The main questions it aims to answer are:
- Does early intervention in kindergarten lead to greater improvements in phonological and phonemic awareness, vocabulary, and articulation compared to training as usual?
- Does a follow-up intervention in first grade enhance decoding skills and sight word recognition beyond the gains achieved through the kindergarten intervention alone?
- Does phonological awareness at the end of kindergarten mediate the relationship between early intervention and later outcomes in vocabulary, articulation, and decoding?
- Do children who receive both interventions perform better than those who receive only one or none (training as usual), suggesting a cumulative or higher-dose effect?
Read more
Researchers will compare four arms formed through a 2x2 factorial design after randomization to see if whether timing, combination, and sequencing of interventions produce differential effects on literacy outcomes.
Participants will:
- In kindergarten receive either an early literacy intervention or training as usual.
- In first grade receive either a follow-up literacy intervention or training as usual, depending on group allocation.
- Be assessed at key time points in both years, measuring phonological awareness, phonemic awareness, vocabulary, and articulation in kindergarten, and expanding to include decoding and sight word recognition in first grade.
Read the detailed description
Literacy skills are fundamental in modern society. A significant portion of information is conveyed through written language. With the widespread use of the internet, written communication has become even more influential in our daily lives. The ability to read and write supports cognitive development, enhances social interactions, improves comprehension, and contributes to academic achievement. Conversely, a lack of literacy skills can limit access to general knowledge and deprive individuals of these important benefits.
One group that stands to gain significantly from literacy skills is individuals with intellectual disabilities who use augmentative and alternative communication. For these individuals, reading and writing can lead to enhanced self-esteem and increased opportunities for inclusion in school, the workplace, and the broader community.
Research has shown that individuals with intellectual disabilities who use augmentative and alternative communication can learn to read and write. However, it is crucial that literacy instruction is tailored to their specific needs.
- Conditions
- Education
- Being tested
- Early Literacy Intervention in Kindergarten, Literacy Intervention in First Grade
- Keywords
- Literacy intervention, Intellectual disability, Augmentative and alternative communication (AAC), Phonological awareness, Phonemic awareness, Early intervention, Special education, Kindergarten-based intervention, School-based intervention, Reading development
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Literacy Intervention in KindergartenOther
In the kindergarten intervention, children will receive early literacy instruction through the Early Literacy Program, adapted for those using augmentative and alternative communication. Based on Accessible Literacy Learning by Light and McNaughton, the program enables nonverbal responses such as signs, symbol pointing, or eye-gaze, removing the need for speech. Instruction follows evidence-based practices including direct and explicit teaching, scaffolding, immediate feedback, cumulative review, practice, and subvocal rehearsal. The program targets five foundational literacy skills: phonological awareness, letter-sound correspondence, sound blending, shared reading, and understanding concepts about print. Supplementary materials such as flashcards and lotto games will also be used to reinforce learning.
Literacy Intervention in First GradeOther
In the first-grade intervention, students will receive literacy instruction using the Reading for All program, which is adapted for children who use augmentative and alternative communication. Based on Accessible Literacy Learning by Light and McNaughton, the program allows responses through nonverbal methods like signs, symbol pointing, or eye-gaze, eliminating the need for oral replies. Instruction is grounded in evidence-based practices such as direct and explicit instruction, scaffolding, immediate corrective feedback, cumulative review, practice, and subvocal rehearsal. Reading for All addresses six key literacy skills: sound blending, letter-sound correspondence, phoneme segmentation, sight word recognition, shared reading, and decoding. Additional activities (flashcards and lotto games) will be a supplement to the material.
| Study group | Role | What they receive |
|---|---|---|
| Combined Intervention: Kindergarten and First Grade | Experimental | Participants in this arm will receive a structured literacy intervention in both kindergarten and first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, the intervention builds on these foundational skills and targets more advanced reading abilities, such as decoding and sight word recognition. Individualized intervention sessions are delivered by the participant's designated special needs educator or teacher at their respective kindergarten or school. This arm is designed to assess the cumulative effects of receiving both early literacy and reading interventions across kindergarten and first grade. Receives: Other: Early Literacy Intervention in Kindergarten; Other: Literacy Intervention in First Grade |
| Intervention in Kindergarten and Training as Usual in First Grade | Experimental | Participants in this arm will receive a structured literacy intervention in kindergarten and training as usual in first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, participants will receive training as usual, meaning they will follow the standard school curriculum without additional literacy intervention from the study. This arm is designed to evaluate the effects of early intervention alone, without follow-up support in first grade. Receives: Other: Early Literacy Intervention in Kindergarten |
| Training as Usual in Kindergarten and Reading Intervention in First Grade | Experimental | Participants in this arm will receive training as usual during kindergarten and a structured reading intervention in first grade. During kindergarten, they will attend regular classroom instruction without receiving any early literacy intervention from the study. In first grade, they will participate in individualized reading intervention sessions focused on early literacy skills, decoding and sight word recognition, delivered by trained educators or specialists. This arm is designed to evaluate the effects of the first-grade reading intervention alone, without prior early literacy support. Receives: Other: Literacy Intervention in First Grade |
| Training as Usual in Kindergarten and First Grade | No intervention | Participants in this arm will receive training as usual during both kindergarten and first grade. They will attend standard classroom instruction without receiving any additional literacy intervention from the study. This arm serves as the control group and is designed to evaluate typical developmental progress in the absence of targeted intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten
All participants will be assessed five times in phonological awareness and letter-sound correspondence during their final year of kindergarten. These tests are part of the Reading for All materials.
Measured: 5 weeks
Phonological Awareness, Letter-Sound Correspondence and Decoding Assessed in First Grade
All participants will be assessed five times in phonological awareness, letter-sound correspondence and decoding during first grade. These tests are part of the Reading for All materials.
Measured: 5 weeks
Secondary outcomes (4)
Vocabular assessment in kindergarten
All participants will be assessed twice using the MacArthur-Bates Communicative Development Inventories before and after the kindergarten intervention.
Measured: 2 weeks
Vocabular assessment in first grade
All participants will be assessed using the MacArthur-Bates Communicative Development Inventories after the first grade intervention.
Measured: 1 week
Articulation assessment in kindergarten
All participants will be assessed before and after the kindergarten intervention.
Measured: 2 weeks
Articulation assessment in first grade
All participants will be assessed after the first grade intervention.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Aug 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies 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
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostfold University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University of South-Eastern Norway, Karolinska Institutet, Heidelberg University, Penn State University
- Responsible party
- Sponsor
- Investigators
- Anders Nordahl-Hansen, PhD, Principal investigator, Østfold University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116200
- Sponsor's protocol ID
- NRC: 353017
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the Findable, Accessible, Interoperable, Reusable Data Principles, the trial protocol, its registration, and models created to analyse the data during the project will be made available on platforms such as Open Science Framework and https://clinicaltrials.gov/. Project objectives and results will be communicated to the general public through newsletters, social media, mainstream media (regional newspaper), and presentations at showcase events. Lastly, we plan to launch a publicly accessible website of the project, describing the project, including its goals and the partners.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07116200
- Acronym / sponsor ID
- NRC: 353017
- Conditions
- Education
- Keywords
- Literacy intervention, Intellectual disability, Augmentative and alternative communication (AAC), Phonological awareness, Phonemic awareness, Early intervention, Special education, Kindergarten-based intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ostfold University CollegeUniversity, hospital or other
- Collaborators
- University of Oslo, University of South-Eastern Norway, Karolinska Institutet, Heidelberg University, Penn State University
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Aug 2025 (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 2x2 factorial randomized controlled trial is to evaluate the effectiveness of two literacy interventions delivered at different time points, in kindergarten and in first grade, on the development of literacy skills in children with intellectual disabilities who require augmentative and alternative communication. The main questions it aims to answer are:
- Does early intervention in kindergarten lead to greater improvements in phonological and phonemic awareness, vocabulary, and articulation compared to training as usual?
- Does a follow-up intervention in first grade enhance decoding skills and sight word recognition beyond the gains achieved through the kindergarten intervention alone?
- Does phonological awareness at the end of kindergarten mediate the relationship between early intervention and later outcomes in vocabulary, articulation, and decoding?
- Do children who receive both interventions perform better than those who receive only one or none (training as usual), suggesting a cumulative or higher-dose effect?
Researchers will compare four arms formed through a 2x2 factorial design after randomization to see if whether timing, combination, and sequencing of interventions produce differential effects on literacy outcomes.
Participants will:
- In kindergarten receive either an early literacy intervention or training as usual.
- In first grade receive either a follow-up literacy intervention or training as usual, depending on group allocation.
- Be assessed at key time points in both years, measuring phonological awareness, phonemic awareness, vocabulary, and articulation in kindergarten, and expanding to include decoding and sight word recognition in first grade.
Detailed description
Literacy skills are fundamental in modern society. A significant portion of information is conveyed through written language. With the widespread use of the internet, written communication has become even more influential in our daily lives. The ability to read and write supports cognitive development, enhances social interactions, improves comprehension, and contributes to academic achievement. Conversely, a lack of literacy skills can limit access to general knowledge and deprive individuals of these important benefits.
One group that stands to gain significantly from literacy skills is individuals with intellectual disabilities who use augmentative and alternative communication. For these individuals, reading and writing can lead to enhanced self-esteem and increased opportunities for inclusion in school, the workplace, and the broader community.
Research has shown that individuals with intellectual disabilities who use augmentative and alternative communication can learn to read and write. However, it is crucial that literacy instruction is tailored to their specific needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combined Intervention: Kindergarten and First Grade | Experimental | Other: Early Literacy Intervention in Kindergarten, Other: Literacy Intervention in First GradeParticipants in this arm will receive a structured literacy intervention in both kindergarten and first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, the intervention builds on these foundational skills and targets more advanced reading abilities, such as decoding and sight word recognition. Individualized intervention sessions are delivered by the participant's designated special needs educator or teacher at their respective kindergarten or school. This arm is designed to assess the cumulative effects of receiving both early literacy and reading interventions across kindergarten and first grade. |
| Intervention in Kindergarten and Training as Usual in First Grade | Experimental | Other: Early Literacy Intervention in KindergartenParticipants in this arm will receive a structured literacy intervention in kindergarten and training as usual in first grade. The kindergarten intervention focuses on developing early literacy skills, including phonological awareness and phonemic awareness. In first grade, participants will receive training as usual, meaning they will follow the standard school curriculum without additional literacy intervention from the study. This arm is designed to evaluate the effects of early intervention alone, without follow-up support in first grade. |
| Training as Usual in Kindergarten and Reading Intervention in First Grade | Experimental | Other: Literacy Intervention in First GradeParticipants in this arm will receive training as usual during kindergarten and a structured reading intervention in first grade. During kindergarten, they will attend regular classroom instruction without receiving any early literacy intervention from the study. In first grade, they will participate in individualized reading intervention sessions focused on early literacy skills, decoding and sight word recognition, delivered by trained educators or specialists. This arm is designed to evaluate the effects of the first-grade reading intervention alone, without prior early literacy support. |
| Training as Usual in Kindergarten and First Grade | No intervention | –Participants in this arm will receive training as usual during both kindergarten and first grade. They will attend standard classroom instruction without receiving any additional literacy intervention from the study. This arm serves as the control group and is designed to evaluate typical developmental progress in the absence of targeted intervention. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitations service or currently undergoing such an evaluation
- ages 4-8 (the last year in kindergarten)
- lack of functional speech and must use augmentative and alternative communication as the primary form of communication
- have a (designated) special education kindergarten teacher
Key exclusion criteria (3 listed)
- having a severe visual or hearing impairment
- children who can decode syllables or words
- children with severe physical disabilities prevent the children from being able to answer with their fingers, unless they can respond with eye pointing or signs
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 |
|---|---|---|
| Early Literacy Intervention in KindergartenIn the kindergarten intervention, children will receive early literacy instruction through the Early Literacy Program, adapted for those using augmentative and alternative communication. Based on Accessible Literacy Learning by Light and McNaughton, the program enables nonverbal responses such as signs, symbol pointing, or eye-gaze, removing the need for speech. Instruction follows evidence-based practices including direct and explicit teaching, scaffolding, immediate feedback, cumulative review, practice, and subvocal rehearsal. The program targets five foundational literacy skills: phonological awareness, letter-sound correspondence, sound blending, shared reading, and understanding concepts about print. Supplementary materials such as flashcards and lotto games will also be used to reinforce learning. | Other | Combined Intervention: Kindergarten and First Grade, Intervention in Kindergarten and Training as Usual in First Grade |
| Literacy Intervention in First GradeIn the first-grade intervention, students will receive literacy instruction using the Reading for All program, which is adapted for children who use augmentative and alternative communication. Based on Accessible Literacy Learning by Light and McNaughton, the program allows responses through nonverbal methods like signs, symbol pointing, or eye-gaze, eliminating the need for oral replies. Instruction is grounded in evidence-based practices such as direct and explicit instruction, scaffolding, immediate corrective feedback, cumulative review, practice, and subvocal rehearsal. Reading for All addresses six key literacy skills: sound blending, letter-sound correspondence, phoneme segmentation, sight word recognition, shared reading, and decoding. Additional activities (flashcards and lotto games) will be a supplement to the material. | Other | Combined Intervention: Kindergarten and First Grade, Training as Usual in Kindergarten and Reading Intervention in First Grade |
Primary outcome
Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten
Time frame: 5 weeks
All participants will be assessed five times in phonological awareness and letter-sound correspondence during their final year of kindergarten. These tests are part of the Reading for All materials.
Phonological Awareness, Letter-Sound Correspondence and Decoding Assessed in First Grade
Time frame: 5 weeks
All participants will be assessed five times in phonological awareness, letter-sound correspondence and decoding during first grade. These tests are part of the Reading for All materials.
4 secondary outcomes
Vocabular assessment in kindergarten
Time frame: 2 weeks
Vocabular assessment in first grade
Time frame: 1 week
Articulation assessment in kindergarten
Time frame: 2 weeks
Articulation assessment in first grade
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. Following the Findable, Accessible, Interoperable, Reusable Data Principles, the trial protocol, its registration, and models created to analyse the data during the project will be made available on platforms such as Open Science Framework and https://clinicaltrials.gov/. Project objectives and results will be communicated to the general public through newsletters, social media, mainstream media (regional newspaper), and presentations at showcase events. Lastly, we plan to launch a publicly accessible website of the project, describing the project, including its goals and the partners.
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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.
Anders Nordahl-Hansen, PhD principal investigator
Østfold University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Literacy Intervention in Kindergarten and Literacy Intervention in First Grade in people with Education, run by Ostfold University College at 1 site 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Phonological Awareness and Letter-Sound Correspondence Assessed in Kindergarten (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.