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

NCT07116200 | Active Not Recruiting

• 1 other identifier: NRC: 353017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Education

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 weeks

Secondary Outcomes (4)

• Vocabular assessment in kindergarten

  2 weeks

• Vocabular assessment in first grade

  1 week

• Articulation assessment in kindergarten

  2 weeks

• Articulation assessment in first grade

  1 week

Study Arms (4)

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.

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.

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.

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.

Interventions

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.

Combined Intervention: Kindergarten and First Grade; Intervention in Kindergarten and Training as Usual in First Grade

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.

Combined Intervention: Kindergarten and First Grade; Training as Usual in Kindergarten and Reading Intervention in First Grade

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold University College: lead
• University of Oslo: collaborator
• University of South-Eastern Norway: collaborator
• Karolinska Institutet: collaborator
• Heidelberg University: collaborator
• Penn State University: collaborator

Study Sites (1)

Østfold University College

Halden, Østfold fylke, 1757, Norway

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Anders Nordahl-Hansen, PhD

  Østfold University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Study protocol: August 2025- August 2028 Statistical analysis Plan: August 2026- December 2027 Analytic Code: August 2026- December 2027

Locations

NO (1)