Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents with Special Needs
NCT ID: NCT06717282
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-12-15
2026-11-21
Brief Summary
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The main question it aims to answer is:
"Does this structured program increase ophthalmic examination compliance in children and adolescents with special needs?"
Participants will:
1. Attend six individualized training sessions (one session every two weeks, each lasting one hour)
2. Engage in activities to practice and enhance cooperation during ophthalmic examination
3. Undergo pre- and post-program assessments to measure visal function, behavioral adaptation, and other intervention outcomes.
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Detailed Description
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Intervention Overview:
1. Training Sessions: Each participant will attend six one-on-one sessions over three months, with each session lasting one hour. The frequency of sessions is adjustable but generally follows a biweekly schedule.
2. Structured Strategies: The intervention incorporates contextual strategies (e.g., simulating clinic environments), behavioral reinforcement (e.g., use of rewards), and cognitive tools (e.g., animated instructions) to facilitate learning and generalization of ophthalmic procedures.
3. Parental Involvement: Parents will be engaged throughout the intervention to ensure continuity of training at home.
Quality assurance plan :
1. Regular site monitoring and auditing will be conducted to maintain data quality and protocol adherence.
2. Systematic checks will compare collected data against predefined ranges and consistency rules, ensuring reliability.
3. Missing data will be addressed using standard imputation techniques or sensitivity analyses, ensuring robustness of the results.
Sample Size Assessment:
The study includes a planned sample size of 50 participants, which is deemed sufficient to detect significant changes in primary outcomes with appropriate statistical power.
Analysis Plan:
Primary and secondary outcomes will be assessed using appropriate statistical methods to measure changes in compliance, visual function, and behavior after the intervention.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention to improve ophthalmic compliance
visual rehabilitation for ophthalmic compliance
contextual, behavioral, and cognitive-based program for ophthalmic compliance
Using contextual, behavioral, and cognitive-based stragegies to develop training programs
Key Features of the Intervention:
1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions.
2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions.
3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization.
4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles.
Duration and Frequency:
Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
Interventions
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visual rehabilitation for ophthalmic compliance
contextual, behavioral, and cognitive-based program for ophthalmic compliance
Using contextual, behavioral, and cognitive-based stragegies to develop training programs
Key Features of the Intervention:
1. Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions.
2. Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions.
3. Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization.
4. Individualized Goals: Individualized training plans and objectives are established collaboratively with caregivers based on participants' cognitive and behavioral profiles.
Duration and Frequency:
Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with or suspected of having autism spectrum disorder, developmental delay, or intellectual disability.
3. Experiencing difficulties cooperating with routine ophthalmologic examinations in general medical facilities due to cognitive, behavioral, or emotional challenges.
Exclusion Criteria
2 Years
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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Department of Occupational Therapy, College of Medicine, National Taiwan University
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202410102RINB
Identifier Type: -
Identifier Source: org_study_id
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