NCT06766188

Brief Summary

The aim of this study is to investigate , via a randomized control trial (RCT), the effectiveness of an online video training platform designed for teachers to support the improvement of basic reading skills of children with intellectual disabilities (ID) who require augmentative and alternative communication (AAC). This intervention will include 14 schools and 70 students with ID who require AAC age 6-14 years old. The research question is: 1\) What is the difference between online video training and in-person training on improving word-level readig skills and phonological awareness? The students will work with a reading material, Reading for All, that follow the strategies of Accessible Literacy Learning, developed by Janice Light and David McNaughton. Reading for All is based on the research of Janice Light and David McNaughton. The reading material are adapted for AAC-users and the students can answer with pointing or their AAC-systems. Teachers will implement the instructions at the students familiar place at school for three to five days, each week, for a year. The reading material consist of tasks in sound blending, letter-sound correspondence, phoneme segmentation, sight words, shared reading and decoding. The teachers will use evidence based, systematic and explicit instructions and immediate and corrective feedback

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2026

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

November 29, 2024

Last Update Submit

February 16, 2025

Conditions

Keywords

intellectual disabilitiesAACShared readingreading interventionSound blendingletter-sound correspondencePhoneme segmentationDecodingsight wordseducationonline video training

Outcome Measures

Primary Outcomes (1)

  • Early reading skills outcome

    Primary outcome will be assessed six times every two months over one year. * Sound blending \[score ranging from 0 to 15\] involves testing the student's ability to combine individual sounds into words. * Letter-sound correspondence \[score ranging from 0 to 25\] involves testing the students' ability to correspond between the sounds of speech (phonemes) and the written letters representing speech (graphemes). * Phoneme segmentation \[score ranging from 0 to 20\] tests students' ability to segment the first phoneme of the word (e.g., s for sun).

    From intervention start to the end of intervention at twelve months

Secondary Outcomes (2)

  • Reading outcome

    From intervention start to the end of intervention at twelve months

  • Vocabulary

    From intervention start to the end of intervention at twelve months

Study Arms (2)

Video training for teachers

ACTIVE COMPARATOR

It is 14 schools and they will be randomized into two groups. The teachers at seven schools will receive video training on how to carry out the reading intervention.

Other: Online Video training for Teachers based on Reading for all

In-person mentoring for teachers

EXPERIMENTAL

It is 14 schools and they will be randomized into two groups. The teachers at seven schools will receive in-person training on how to carry out the reading intervention

Other: Online Video training for Teachers based on Reading for all

Interventions

Reading intervention over a year for students with intellectual disabilities who use AAC. This study included teachers from 14 different schools and 8 municipalities and their students. It is two arms in the intervention, with approximately 7 schools and their teachers in "video training for teachers" and "in person mentoring for teachers". The schools are randomized into these two groups, but in both groups, they will carry out the same intervention. The students in both groups will work explicitly and systematically with the reading material "Reading for all", which is based on the research of, among others, Janice Light and David McNaughton, and their reading program "Accessible Literacy Learning (ALL)".

In-person mentoring for teachersVideo training for teachers

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ages 6-14 years,
  • diagnosed with intellectual disability, confirmed by multidisciplinary assessments carried out by the Child rehabilitation service,
  • not have a functional speech, i.e. require AAC to understand and make oneself understood,
  • must use AAC as their primary form of communication,
  • cannot follow ordinary curricula (LK20) but have their own education plan.

You may not qualify if:

  • having a severe visual impairment and not being able to decode single words (e.g., severe hearing impairment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold University College

Halden, 1757, Norway

Location

Related Publications (2)

  • Ulriksen LB, Bilet-Mossige M, Cogo-Moreira H, Oien R, Nordahl-Hansen A. Reading instruction for students with intellectual disabilities who require augmentative and alternative communication: A multiple single case study with baseline, posttest, follow-up, and maintenance. Res Dev Disabil. 2024 Aug;151:104790. doi: 10.1016/j.ridd.2024.104790. Epub 2024 Jun 26.

    PMID: 38935986BACKGROUND
  • 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.

    PMID: 37370125BACKGROUND

MeSH Terms

Conditions

Autistic DisorderIntellectual Disability

Interventions

Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

raf KinasesMAP Kinase Kinase KinasesProtein Serine-Threonine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and ProteinsProto-Oncogene ProteinsOncogene ProteinsNeoplasm Proteins

Study Officials

  • Hugo Cogo Moreira, Professor

    Ostfold University College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2024

First Posted

January 9, 2025

Study Start

November 25, 2024

Primary Completion

March 17, 2025

Study Completion

March 18, 2026

Last Updated

February 19, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

Following the FAIR Data Principles, the trial protocol, its registration, and models created to analyze the data during the project will be made available on platforms such as OSF 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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Study protocol: January 2025- August 2027 Statistical analysis Plan: May 2026- August 2027 Analytic Code: June 2026- August 2027

Locations