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NCT Number: NCT07116200

Effectiveness of an Early Reading Intervention for Young Children With Intellectual Disabilities Who Need or Use Augmentative and Alternative Communication

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Education Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold University College

Halden, Østfold fylke, 1757, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Early Literacy Intervention in Kindergarten

Other

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 Grade

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Vocabular assessment in kindergarten

    Time frame: 2 weeks

    All participants will be assessed twice using the MacArthur-Bates Communicative Development Inventories before and after the kindergarten intervention.

  2. Vocabular assessment in first grade

    Time frame: 1 week

    All participants will be assessed using the MacArthur-Bates Communicative Development Inventories after the first grade intervention.

  3. Articulation assessment in kindergarten

    Time frame: 2 weeks

    All participants will be assessed before and after the kindergarten intervention.

  4. Articulation assessment in first grade

    Time frame: 1 week

    All participants will be assessed after the first grade intervention.

Sponsors and collaborators

Lead sponsor

Ostfold University College

Other

Collaborators

  • Heidelberg University
  • Karolinska Institutet
  • Penn State University
  • University of Oslo
  • University of South-Eastern Norway

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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