NCT05709405

Brief Summary

The goal of this multiple single case study with multiple randomized baseline (with four starting points and 18 measurements across time) is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC). The main questions to answer are:

  1. 1.Is there a functional relation between the use of "Lesing for alle" (Reading for all) and increased accuracy of sound blending by students age 6-14 with intellectual disabilities who require AAC?
  2. 2.Is there a functional relation between the use of "Lesing for alle" (Lesing for alle) and improved acquisition of letter sound correspondence by students age 6-14 with intellectual disabilities who require AAC?
  3. 3.Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of phoneme segmentation by students age 6-14 with intellectual disabilities who require AAC?
  4. 4.Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of recognition of sight words by students age 6-14 with intellectual disabilities who require AAC?
  5. 5.Is there a functional relation between the use of "Lesing for alle" (Reading for all) and improved acquisition of decoding by students age 6-14 with intellectual disabilities who require AAC?
  6. 6.Is there a positive and strong correlation between increasing skills from 1-3 and 4-5? Meaning, is there a transfer from lower level skills (phonological skills) to decoding skills?

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

2.1 years

First QC Date

January 10, 2023

Last Update Submit

August 7, 2024

Conditions

Keywords

Intellectual disabilitiesAACReading interventionSound blendingLetter-sound correspondencePhoneme segmentationShared readingSight wordsDecoding

Outcome Measures

Primary Outcomes (3)

  • Sound-blending trajectory change

    Testing in sound blending involves testing the student's ability to combine individual sounds into words. The students will see a sheet of paper with four symbols. In the instructions, the target word will be presented by expanding the individual sound in the word.

    Every month, for 18 months

  • Letter-sound correspondence trajectory change

    Tests the student's ability to associate letter-sounds with corresponding letters. The students must discriminate between 4 symbols, and the instruction is, for example: point to "0".

    Every month, for 18 months

  • Phoneme segmentation trajectory change

    The students are measured on their ability to find the first sound in words. In the test, there must be discrimination between 4 symbols, and students must identify the word that begins with, for example, the sound "m".

    Every month, for 18 months

Secondary Outcomes (2)

  • Sight-words change

    Three time points before, during, and after intervention (months 1, 12 and 18)

  • Decoding change

    Three time points before, during and after intervention (months 1, 12 and 18)

Study Arms (1)

Reading Intervention

EXPERIMENTAL

The reading material is made based on the research of Professor Janice Light and Professor David McNaughton at Penn State University. The reading material "Lesing for alle" (Reading for all) contains all the principles, strategies, and methods that form the basis of Accessible Literacy Learning (ALL). The intervention is conducted by trained teachers, in a place known to the students. The material contains: tasks in sound blending, letter-sound correspondence, phoneme- segmentation, sight words, single-word decoding, and shared reading. Due to the multiple single baseline design, each participant will be regarded as being in the control condition, and then will be randonly assigned to four different baselines starting the intervention individually after the 2nd, 3rd, 4th, and 5th month.

Other: Reading intervention

Interventions

The intervention will use a reading program called "Lesing for alle" (Reading for all) based on the research of Accessible Literacy Learning (ALL) which is an evidence-based approach, designed to teach reading skills to students with various intellectual disabilities, including autism spectrum disorders

Reading Intervention

Eligibility Criteria

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

You may qualify if:

  • Students between 6 and 14
  • Students who are diagnosed with intellectual disabilities
  • Students who do not have a functional speech, i.e. require augmentative and alternative communication (AAC) to understand and/or make oneself understood.
  • Students must use AAC as their primary form of communication
  • Students cannot follow ordinary curricula (LK20) but have their own education plan.

You may not qualify if:

  • Students younger than six years and older than 14 years
  • Students who have not been diagnosed within intellectual disabilities
  • Students who have a functional speech and do not require AAC
  • Students who follow ordinary education

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Østfold University College

Halden, BRA Veien, 1757, Norway

Location

University of South-Eastern Norway

Borre, Vestfold, 3199, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kenneth Larsen, Phd

    University of South-Eastern Norway

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multiple random baseline design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 2, 2023

Study Start

September 1, 2022

Primary Completion

October 15, 2024

Study Completion

December 18, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations