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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention to improve ophthalmic compliance | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| visual rehabilitation for ophthalmic compliance | Behavioral | contextual, behavioral, and cognitive-based program for ophthalmic compliance |
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| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Occupational Therapy, College of Medicine, National Taiwan University | Taipei | Taiwan |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Intervention to Improve 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2026 |
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| Using contextual, behavioral, and cognitive-based stragegies to develop training programs | Behavioral | Key Features of the Intervention:
Duration and Frequency: Six sessions, each lasting one hour, are conducted biweekly, with flexibility based on caregiver availability. |
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| Baseline (pre-intervention) and post-intervention (within 6 months). |
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Baseline characteristics were collected for all enrolled participants (N = 20).
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental : Intervention to Improve 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline age data were available for all enrolled participants (N = 20). | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Sex was recorded for all enrolled participants (N = 20). | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Fourteen participants (N = 14) were included in the outcome analysis due to incomplete pre- and/or post-intervention data in 6 participants. | Posted | Median | Standard Deviation | score | Pre-intervention and post-intervention (within 6 months) |
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| Secondary | 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). | Fourteen participants (N =14) were included in the outcome analysis due to incomplete pre- and/or post-intervention data in 10 participants. | Posted | Mean | Standard Deviation | score | Baseline (pre-intervention) and post-intervention (within 6 months). |
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From enrollment to completion of the post-intervention assessment (within 6 months).
Adverse events were assessed throughout the study period. No serious adverse events or other adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Intervention to Improve 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Li-Ting Tsai, PhD (Central Contact Person) | Department of Occupational Therapy, College of Medicine, National Taiwan University Taipei, , Taiwan | +886-2-33668164 | litingtsai@ntu.edu.tw |
| Jan 21, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D000067877 | Autism Spectrum Disorder |
| D002658 | Developmental Disabilities |
| D008607 | Intellectual Disability |
| D001526 | Behavioral Symptoms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Male |
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Statistical significance was evaluated using the Wilcoxon signed-rank test for paired pre- and post-intervention data within the intervention group (N = 14). A two-sided p-value < 0.05 was considered statistically significant.
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