Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID07036575

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

Led by National Taiwan University Hospital · Updated on 2025-06-25

250

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

M

Ministry of Health and Welfare, Taiwan

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve visual health knowledge and access among children and adolescents aged 3 to under 18 with intellectual disabilities or developmental delays. It addresses challenges faced by this group in receiving medical information and preventive care due to communication barriers and limited support tools. The program includes developing easy-to-read materials and inclusive technologies to support education and early detection of visual health issues. Participants will be randomly assigned to one of three groups: standard visual health education using conventional materials with instructor explanations, Easy-to-Read instructor-guided education with simplified images and plain language, or Easy-to-Read audio-based self-learning using a voice-assisted pen device for independent study. The study involves an initial pre-assessment phase, followed by a pre-test, instructional phase, and post-test, all within a one-month window. Throughout the study, participants will undergo assessments including adaptive behavior scales, cognitive or developmental evaluations, and visual tests. Researchers will measure improvements in eye health knowledge using pre- and post-tests. The study also monitors participants' comprehension and allows a repeat instructional session if needed. The total participation includes a 50-minute baseline assessment and same-day instructional and testing sessions lasting about 20 minutes.

CONDITIONS

Brief Title

Easy-to-Read Content Effectiveness Evaluation

Who Can Participate

Age: 3Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 3 to under 18
  • Diagnosed with intellectual disabilities or developmental delays
  • Able to correctly identify at least two out of three simple images during pre-assessment
Not Eligible

You will not qualify if you...

  • Severe cognitive impairments that interfere with assessments or participation
  • Hearing impairments that affect participation
  • Speech disorders that interfere with instructional activities
  • Motor disabilities that prevent engagement in study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pre-assessment Phase

Duration - Approximately 50 minutes

Participants undergo background information collection, adaptive behavior assessment, cognitive or developmental evaluations, visual assessments, and a picture recognition test.

1 visit (in-person)

Pre-test Phase

Duration - Approximately 5 minutes

Participants complete a brief pre-test consisting of 8 questions assessing basic eye health knowledge.

1 visit (in-person)

Instructional Phase

Duration - Time needed to complete instructional session(s) on the same day

Participants receive health education in one of three formats: conventional instructor-led, easy-to-read instructor-guided, or easy-to-read audio self-learning. Instruction may be repeated once if comprehension is not achieved.

1 visit (in-person)

Post-test Phase

Duration - Approximately 10 minutes

Participants complete a distraction task followed by a post-test retaking the same eye health knowledge test used in the pre-test.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Intellectual and developmental disability centers and related institutions

Taipei, Taiwan

Actively Recruiting

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Research Team

L

Li-Ting Tsai

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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