NCT06717282

Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents With Special Needs

Evaluation of a Contextual, Behavioral, and Cognitive-based Program to Improve Ophthalmic Compliance in Children and Adolescents With Special Needs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the effects of the structured program incorporating contextual, behavioral, and cognitive strategies to improve compliance of children and adolescents with special needs during examinations in specialized or general ophthalmic settings. 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.

Detailed description

This study investigates the effectiveness of a contextual, behavioral, and cognitive-based intervention program designed to enhance ophthalmic compliance in children and adolescents with special needs. The program includes six individualized training sessions conducted by occupational therapists with expertise in vision rehabilitation. These sessions integrate environmental adaptation, positive reinforcement, and cognitive strategies to improve the participants' cooperation during ophthalmic examinations. 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

• Visual Rehabilitation
• Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	visual rehabilitation for ophthalmic compliance	contextual, behavioral, and cognitive-based program for ophthalmic compliance
BEHAVIORAL	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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-01-21
• Completion: 2026-01-21
• First posted: 2024-12-04
• Last updated: 2026-03-13
• Results posted: 2026-03-13

Locations

1 site across 1 country: Taiwan