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

NCT06717282 | Completed Results DMC

• 1 other identifier: 202410102RINB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Attend six individualized training sessions (one session every two weeks, each lasting one hour)
2. 2.Engage in activities to practice and enhance cooperation during ophthalmic examination
3. 3.Undergo pre- and post-program assessments to measure visal function, behavioral adaptation, and other intervention outcomes.

Conditions

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

Keywords

Visual rehabilitation, Special need, Compliance, Ophthalmic examination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ophthalmic Visit Adaptation Questionnaire

  Baseline (pre-intervention) and post-intervention (within 6 months).

Study Arms (1)

Intervention to improve ophthalmic compliance

EXPERIMENTAL

Behavioral: visual rehabilitation for ophthalmic compliance; Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs

Interventions

visual rehabilitation for ophthalmic compliance BEHAVIORAL

contextual, behavioral, and cognitive-based program for ophthalmic compliance

Intervention to improve ophthalmic compliance

Using contextual, behavioral, and cognitive-based stragegies to develop training programs BEHAVIORAL

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.

Intervention to improve ophthalmic compliance

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 2 and 18 years.
• Diagnosed with or suspected of having autism spectrum disorder, developmental delay, or intellectual disability.
• Experiencing difficulties cooperating with routine ophthalmologic examinations in general medical facilities due to cognitive, behavioral, or emotional challenges.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, Taiwan

Location

MeSH Terms

Conditions

Vision Disorders; Autism Spectrum Disorder; Developmental Disabilities; Intellectual Disability; Behavioral Symptoms; Patient Compliance

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Limitations and Caveats

This single-arm pre-post study had a small sample size and no control group, and outcome analyses were limited to participants with complete data (N = 14), which may limit generalizability.

Results Point of Contact

• Title: Li-Ting Tsai, PhD (Central Contact Person)
• Organization: Department of Occupational Therapy, College of Medicine, National Taiwan University Taipei, , Taiwan

litingtsai@ntu.edu.tw

+886-2-33668164

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: December 15, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)