Intellectual and developmental disability centers and related institutions
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT07036575
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.
Interested in participating?
Request Info3 year–17 year
All sexes
Interventional
Not applicable
Taipei, Taiwan
Location status: Recruiting
We will recruit 250 children and adolescents (age 3 to under 18) with intellectual disabilities or developmental delays.
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.
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Integrated Program for Promoting Visual Health and Technological Applications for Individuals With Intellectual Disabilities
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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