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临床试验/NCT07036575
NCT07036575招募中不适用

Integrated Program for Promoting Visual Health and Technological Applications for Individuals With Intellectual Disabilities

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Test of basic eye health knowledge Knowledge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Test of basic eye health knowledge Knowledge

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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