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
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:
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.
We will recruit 250 children and adolescents (age 3 to under 18) with intellectual disabilities or developmental delays.
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:
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.
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.
Instructional Phase
Participants will be randomly assigned to one of the following three instructional groups:
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.
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.
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 →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.
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Exclusion Criteria:
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
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
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
Participants receive conventional eye health education using standard visual materials, explained by an instructor.
Participants receive Easy-Read health education through 16 simplified images with instructor-guided explanation using plain language and pictorial content.
Participants use a voice-assisted pen device to self-learn Easy-Read materials (16 images) with audio explanations, without additional teacher guidance.
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
Plan to share: No
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