Easy-to-Read Content Effectiveness Evaluation

Not Applicable

Recruiting

• Conditions: Health Knowledge; Intellectual Developmental Disorder; Visual Impairment

• Registration Number: NCT07036575
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-06
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Test of basic eye health knowledge Knowledge	3 months	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.

Trial Locations

Locations (1)

Intellectual and developmental disability centers and related institutions; 🇨🇳 Taipei, Taiwan