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

NCT ID: NCT07116200

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2029-12-31

Brief 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 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.

Conditions

Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined Intervention: Kindergarten and First Grade

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.

Group Type: EXPERIMENTAL

Early Literacy Intervention in Kindergarten

Intervention Type: 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

Intervention Type: 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.

Intervention in Kindergarten and Training as Usual in First Grade

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.

Group Type: EXPERIMENTAL

Early Literacy Intervention in Kindergarten

Intervention Type: 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.

Training as Usual in Kindergarten and Reading Intervention in First Grade

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.

Group Type: EXPERIMENTAL

Literacy Intervention in First Grade

Intervention Type: 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.

Training as Usual in Kindergarten and First Grade

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early Literacy Intervention in Kindergarten

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.

Intervention Type: OTHER

Literacy Intervention in First Grade

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

University of South-Eastern Norway

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: collaborator

Ostfold University College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Nordahl-Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Østfold University College

Locations

Østfold University College

Halden, Østfold fylke, Norway

Countries

Norway

Other Identifiers

NRC: 353017

Identifier Type: -

Identifier Source: org_study_id