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

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.

Study Overview

• Status: Completed
• Conditions: Visual Rehabilitation; Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
• Intervention / Treatment: Behavioral: visual rehabilitation for ophthalmic compliance; Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Department of Occupational Therapy, College of Medicine, National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 2 and 18 years.
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:

• Children and adolescents with developmental delays or disabilities who are capable of undergoing routine vision screenings during regular ophthalmologic visits or school health check-ups.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention to improve ophthalmic compliance

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: Contextual Adaptation: Participants practice ophthalmic examination procedures in a simulated clinical environment to familiarize themselves with real-world conditions.; Behavioral Strategies: Positive reinforcement, such as rewards (snacks, toys, or videos), is used to encourage participation and cooperation during sessions.; Cognitive Support: Animated materials and interactive exercises are employed to teach the concepts required for visual tests, with take-home tasks for generalization.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Function Battery for Children With Special Needs (VFB-CSN)	The Visual Function Battery for Children with Special Needs (VFB-CSN) is a standardized measure assessing multiple domains of visual function in children and adolescents with special needs. The VFB-CSN contains eight categories, namely visual reflex, ocular muscle balance, visual acuity, oculomotor, visual field, contrast sensitivity, colour/form vision, and visual attention. The total scores of the VFB-CSN ranges from 0 to 60. Higher scores indicate better visual function.	Pre-intervention and post-intervention (within 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ophthalmic Visit Adaptation Questionnaire	The Ophthalmic Visit Adaptation Questionnaire was developed to assess adaptive behaviors and degrees of cooperation during ophthalmic examination in both special ophthanmic clinics and general ophthalmic clinics for children/adolescents with special needs. The questionnaire consists of 18 items, and each item is rated a 5-point Likert scale raning from 1 to 5, where higher scores indicate better adaptation and cooperation. The total score is calculated by summing the 18 item scores. Therefore, total scores range from 18 to 90 (scores on a scale).	Baseline (pre-intervention) and post-intervention (within 6 months).

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): January 21, 2026
• Study Completion (Actual): January 21, 2026

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Visual rehabilitation, Special need, Compliance, Ophthalmic examination
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Eye Diseases; Sensation Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Autism Spectrum Disorder; Developmental Disabilities; Behavioral Symptoms; Intellectual Disability; Vision Disorders; Patient Compliance
• Other Study ID Numbers: 202410102RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No