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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05709405
Other study ID # 988724
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date December 18, 2024

Study information

Verified date June 2023
Source Ostfold University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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. 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. 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. 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. 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. 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? The participants (age 6-14) will receive daily instruction in a reading material that follows all the strategies of Accessible Literacy Learning, developed by Janice Light and David McNaughton. It is the teachers who will carry out the teaching in the students fixed and familiar place at school. The reading material consist of tasks in sound blending, letter-sound correspondence, phoneme segmentation, sight words and decoding. The reading material will use explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. The intervention will take place for a total of 18 months.


Description:

The acquisition of reading skills is a critical need for all individuals and allow fuller participations in education and employment and gives access to personal expression, social media and enjoyable leisure pursuits. Individuals with intellectual disabilities who require augmentative and alternative communication (AAC) often face challenges in that they are met with too low expectations and low ambitions. There is also a lack of evidence-based reading programs and reading materials adapted for individuals who require AAC. This study will conduct a reading intervention for children with intellectual disabilities who require augmentative and alternative communication (AAC). Through the reading intervention, students will work with components such as sound blending, letter-sound correspondence, phoneme segmentation, sight words, shared reading and decoding. It will be used components of effective evidence-based literacy intervention such as explicit instruction, distributed and cumulative practice, and immediate and corrective feedback. All the instructional activities have been adapted, oral/spoken responses are not required, and the students can use alternative methods, such as signs, pointing at symbols or pointing with their eyes. The aim of this study is to conduct a reading intervention for 40 children with intellectual disabilities who require augmentative and alternative communication (AAC) to see if the students can acquire functional reading skills. Even simple reading skills can contribute to major changes in the individual's quality of life and to a greater independence in communication with the environment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 18, 2024
Est. primary completion date October 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Reading intervention
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

Locations

Country Name City State
Norway University of South-Eastern Norway Borre Vestfold
Norway Østfold University College Halden BRA Veien

Sponsors (3)

Lead Sponsor Collaborator
Ostfold University College The Research Council of Norway, University of South-Eastern Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Sight-words change Tests the students ability to recognize words they have learned by sight. Three time points before, during, and after intervention (months 1, 12 and 18)
Secondary Decoding change Tests the students ability to convert the printed code (letters) of traditional ortography into words in order to derive meaning. Three time points before, during and after intervention (months 1, 12 and 18)
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