Health KnowledgeNCT07036575
Easy-to-Read Content Effectiveness Evaluation
A study testing Standard Visual Health Education, Easy-Read Instructor-Guided Education and Easy-Read Audio-Based Self-Learning in people with Health Knowledge and Intellectual Developmental Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Health Knowledge, Intellectual Developmental Disorder, Visual Impairment
- What is being tested?
- Standard Visual Health Education, Easy-Read Instructor-Guided Education and Easy-Read Audio-Based Self-Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Severe cognitive impairments, hearing impairments, speech disorders, or motor disabilities that would interfere with assessment procedures or participation in the instructional activities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Intellectual and developmental disability centers and related institutions
Taipei
Li-Ting Tsai, 886-2-33668164, litingtsai@ntu.edu.tw
About this study
Official title: Integrated Program for Promoting Visual Health and Technological Applications for Individuals With Intellectual Disabilities
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:
Read more
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- Being tested
- Standard Visual Health Education, Easy-Read Instructor-Guided Education, Easy-Read Audio-Based Self-Learning
- Keywords
- Easy-to-Read, intellectal disability, children, special needs, visual impairment, vision health education
- Medical subject headings
- Intellectual Disability, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Visual Health EducationBehavioural
Participants receive conventional eye health education using standard visual materials, explained by an instructor.
Easy-Read Instructor-Guided EducationBehavioural
Participants receive Easy-Read health education through 16 simplified images with instructor-guided explanation using plain language and pictorial content.
Easy-Read Audio-Based Self-LearningBehavioural
Participants use a voice-assisted pen device to self-learn Easy-Read materials (16 images) with audio explanations, without additional teacher guidance.
| Study group | Role | What they receive |
|---|---|---|
| General Health Education Group | Active comparator | 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. Receives: Behavioral: Standard Visual Health Education |
| Easy-to-Read Guided Teaching Group | Experimental | 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. Receives: Behavioral: Easy-Read Instructor-Guided Education |
| Easy-to-Read Audio Self-Learning Group | Experimental | 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. Receives: Behavioral: Easy-Read Audio-Based Self-Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health KnowledgeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Sponsor
- Investigators
- Li-Ting Tsai, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036575
- Sponsor's protocol ID
- 202504004RINA
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Program for Promoting Visual Health and Technological Applications for Individuals With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT07036575
- Acronym / sponsor ID
- 202504004RINA
- Keywords
- Easy-to-Read, intellectal disability, children, special needs, visual impairment, vision health education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Health Education Group | Active comparator | Behavioral: Standard Visual Health EducationParticipants 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. |
| Easy-to-Read Guided Teaching Group | Experimental | Behavioral: Easy-Read Instructor-Guided EducationParticipants 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. |
| Easy-to-Read Audio Self-Learning Group | Experimental | Behavioral: Easy-Read Audio-Based Self-LearningParticipants 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe cognitive impairments, hearing impairments, speech disorders, or motor disabilities that would interfere with assessment procedures or participation in the instructional activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Visual Health EducationParticipants receive conventional eye health education using standard visual materials, explained by an instructor. | Behavioural | General Health Education Group |
| Easy-Read Instructor-Guided EducationParticipants receive Easy-Read health education through 16 simplified images with instructor-guided explanation using plain language and pictorial content. | Behavioural | Easy-to-Read Guided Teaching Group |
| Easy-Read Audio-Based Self-LearningParticipants use a voice-assisted pen device to self-learn Easy-Read materials (16 images) with audio explanations, without additional teacher guidance. | Behavioural | Easy-to-Read Audio Self-Learning Group |
Primary outcome
Test of basic eye health knowledge Knowledge
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Ting Tsai study chair
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Visual Health Education, Easy-Read Instructor-Guided Education and Easy-Read Audio-Based Self-Learning in people with Health Knowledge and Intellectual Developmental Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Ting Tsai (886-2-3366-8164, litingtsai@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of basic eye health knowledge Knowledge (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.