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RecruitingNCT07036575Updated Jun 25, 2025

Easy-to-Read Content Effectiveness Evaluation

An interventional study of Standard Visual Health Education and Easy-Read Instructor-Guided Education in Health Knowledge, Intellectual Developmental Disorder and Visual Impairment, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study summary

Individuals with intellectual disabilities face challenges in accessing medical services and health education due to communication barriers and limited support tools. Traditional information delivery methods often fail to meet their needs, leading to unequal access to preventive care and early screening.

This integrated program aims to promote visual health among individuals with intellectual disabilities through the development and implementation of inclusive technologies. The program consists of three sub-projects:

  1. Visual Health Promotion and Development of an Inclusive Information Platform for Individuals with Intellectual Disabilities - developing accessible health materials for individuals with intellectual disabilities and their families.
  2. Development and Promotion of a Digital Visual Health Screening System for Individuals with Intellectual Disabilities - designed to support early detection and intervention tailored to this population.
  3. Development of a Healthcare Access Platform and Assistive Technologies for Individuals with Intellectual Disabilities - reducing communication barriers during medical visits through technological support.

Previously, our team developed and tested easy-to-read (ETR) materials with adults with intellectual disabilities, focusing on medical visits, eye diseases, and eye care. Once validated, these materials are planned to be adapted into digital versions and serve as the foundation for an online platform.

To evaluate the effectiveness of ETR content, we will conduct an experimental study with 250 children and adolescents with special needs from across Taipei and New Taipei City in Taiwan. Participants will receive different types of visual health education, and outcomes will be measured by improvements in their knowledge. This study aims to validate the impact of ETR resources in reducing health information inequality and improving visual health awareness in this underserved population.

Read the detailed description

We will recruit 250 children and adolescents (age 3 to under 18) with intellectual disabilities or developmental delays.

  1. Pre-assessment Phase:

    At the beginning of the study, background information will be collected for each participant, including date of birth, sex, current school grade, type of disability, presence of ophthalmologic conditions, whether the participant wears glasses, and past visual acuity test results.

    To assess adaptive functioning, the Vineland Adaptive Behavior Scales (VABS) will be completed by either the special education teacher or the homeroom teacher-individuals most familiar with the participant's daily behavior. The VABS is a standardized assessment tool that employs a semi-structured interview format to evaluate adaptive behaviors, including communication, daily living skills, socialization, and motor skills. It is widely used to support the diagnosis of intellectual and developmental disabilities, autism spectrum disorder, and developmental delays.

    Following the adaptive behavior assessment, participants will undergo cognitive or developmental evaluations based on age:

    • For participants aged 3 to 6, the Mullen Scales of Early Learning (MSEL) will be administered. The MSEL is a developmentally integrated assessment system that measures cognitive ability and motor development across domains such as gross and fine motor skills, visual reception, and expressive and receptive language. It provides a reliable and efficient evaluation of early learning abilities.
    • For participants aged 6 to 17, the Wechsler Intelligence Scale for Children (WISC) will be used. The WISC is a widely recognized test of intellectual functioning that assesses a child's overall intellectual ability along with five specific cognitive domains: verbal comprehension, visual spatial, fluid reasoning, working memory, and processing speed.

    In addition, participants will undergo a visual assessment, including evaluations of visual acuities, visual field, and contrast sensitivity. To ensure baseline visual recognition ability, participants will also complete a three-picture recognition test; they must correctly identify at least two out of three images to proceed in the study.

    Considering participants' physical stamina and attention span, Phase 1 will be conducted separately in advance, taking approximately 50 minutes (one class period) to complete.

  2. Pre-test Phase:

    Participants will complete a brief pre-test consisting of 8 questions assessing basic eye health knowledge. Each question has two tiers: an open-ended question worth 2 points if answered correctly, followed by a yes/no question worth 1 point if the open-ended response is incorrect. This phase will take approximately 5 minutes.

  3. Instructional Phase

    Participants will be randomly assigned to one of the following three instructional groups:

    • General Health Education Instruction (Control Group): Participants in this group will receive instruction using conventional materials, such as illustrated storybooks and general health education pamphlets. Instructors will guide the session by pointing to images and explaining the accompanying text.
    • Easy-to-Read Information Instruction (Experimental Group): In this group, instructors will use an easy-to-read booklet as the primary teaching material. During the session, instructors will point to the relevant images and provide explanations based on the simplified accompanying text.
    • Self-operated Easy-to-Read Audio Information (Experimental Group): Participants in this group will also use the easy-to-read booklet. However, the content will be delivered through pre-recorded audio. Using a talking pen, participants will tap on images in the booklet to trigger the corresponding narration, allowing them to learn independently through an audio-guided format.

    Following instruction, participants will be asked to confirm their understanding of the material. If full comprehension is not achieved, the instructional session will be repeated once. Regardless of comprehension level after the second attempt, the process will conclude.

  4. Post-test Phase After the instructional phase, participants will complete a 5-minute distraction task involving poker games. Immediately afterward, they will retake the same eye health knowledge test used in the pre-test. The post-test phase is expected to last approximately 10 minutes.

The pre-test, instructional and post-test phase will all be conducted on the same day. The interval between these sessions and the earlier Phase 1 assessment will not exceed one month.

02

Conditions studied

  • Health Knowledge
  • Intellectual Developmental Disorder
  • Visual Impairment

Keywords

  • Easy-to-Read
  • intellectal disability
  • children
  • special needs
  • visual impairment
  • vision health education
03

In context

Intellectual Disability

387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.

This study's planned enrollment of 250 is above the median of 58 across 248 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children and adolescents aged 3 to under 18
  • Children and adolescents with intellectual disabilities and developmental delays.
  • Children and adolescents who are able to correctly identify at least two out of the three images in the pre-assessment phase.

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairments, hearing impairments, speech disorders, or motor disabilities that would interfere with assessment procedures or participation in the instructional activities.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Active comparator
    General Health Education Group

    Participants in this group receive standard health education using conventional visually-based educational materials (e.g., children's book) related to eye care. A trained instructor explains each image using a structured script designed for general comprehension.

    Behavioral: Standard Visual Health Education

  • Experimental
    Easy-to-Read Guided Teaching Group

    Participants in this group receive health education using an Easy-to-Read version of the materials, consisting of 16 simplified images with pictorial supports and plain-language text. The instruction is delivered one-on-one by a trained educator following a scripted guide optimized for individuals with intellectual or developmental disabilities.

    Behavioral: Easy-Read Instructor-Guided Education

  • Experimental
    Easy-to-Read Audio Self-Learning Group

    Participants in this group receive the same Easy-to-Read materials as Arm 2, but instead of guided teaching, they are instructed to operate a voice-assisted pen device to independently play back pre-recorded audio explanations linked to each image. A researcher supervises the interaction to ensure the device is used correctly, but no additional explanation is provided.

    Behavioral: Easy-Read Audio-Based Self-Learning

Interventions

  • BehavioralStandard Visual Health Education

    Participants receive conventional eye health education using standard visual materials, explained by an instructor.

  • BehavioralEasy-Read Instructor-Guided Education

    Participants receive Easy-Read health education through 16 simplified images with instructor-guided explanation using plain language and pictorial content.

  • BehavioralEasy-Read Audio-Based Self-Learning

    Participants use a voice-assisted pen device to self-learn Easy-Read materials (16 images) with audio explanations, without additional teacher guidance.

06

What researchers measure

Primary outcomes

  1. Test of basic eye health knowledge Knowledge

    This 8-question test assesses basic eye health knowledge. Each item has two stages: an open question (2 points if correct), followed by a yes/no question (1 point if correct) if the first is incorrect. It is given before and after the health education to measure learning outcomes.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Intellectual and developmental disability centers and related institutions
    Taipei, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07036575
Collaborators
Ministry of Health and Welfare, Taiwan
Responsible party
Sponsor
First posted
Jun 25, 2025
Start date
Jun 2025 (estimated)
Primary completion
Jun 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jun 25, 2025

Study contacts

Li-Ting Tsai
Contact
litingtsai@ntu.edu.tw
886-2-3366-8164
Li-Ting Tsai
study chair · National Taiwan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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