An interventional study of visual rehabilitation for ophthalmic compliance and Using contextual, behavioral, and cognitive-based stragegies to develop training programs in Visual Rehabilitation and Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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:
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:
Quality assurance plan :
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's enrollment of 20 is below the median of 78 across 244 interventional studies indexed under Vision Disorders.
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Behavioral: visual rehabilitation for ophthalmic compliance · Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs
contextual, behavioral, and cognitive-based program for ophthalmic compliance
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.
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.
Time frame: Pre-intervention and post-intervention (within 6 months)
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).
Time frame: Baseline (pre-intervention) and post-intervention (within 6 months).
Participants were recruited between December 15, 2024 and January 21, 2026 from a special needs ophthalmology clinic, including children and adolescents who attended the clinic for ophthalmic evaluation.
| Milestone | Experimental: Intervention to Improve Ophthalmic Compliance |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
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.
| score | Experimental: Intervention to Improve Ophthalmic Compliance |
|---|---|
| Baseline (pre-intervention) | 45.00 ± 5.08 |
| Post-intervention | 48.21 ± 5.47 |
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).
| score | Experimental: Intervention to Improve Ophthalmic Compliance |
|---|---|
| Baseline (pre-intervention) | 70.80 ± 17.05 |
| Post-intervention | 78.50 ± 20.17 |
Collected over From enrollment to completion of the post-intervention assessment (within 6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Intervention to Improve Ophthalmic Compliance | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Baseline characteristics were collected for all enrolled participants (N = 20).
| Age, Continuous(Years) | Experimental : Intervention to Improve Ophthalmic Compliance |
|---|---|
| Mean | 6.82 ± 2.64 |
| Sex: Female, Male(Participants) | Experimental : Intervention to Improve Ophthalmic Compliance |
|---|---|
| Female | 8 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | Experimental : Intervention to Improve Ophthalmic Compliance |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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