Evaluation of a Contextual, Behavioral, and Cognitive-based Program to Improve Ophthalmic Compliance in Children and Adolescents With Special Needs
Phase: NA
Conditions: Visual Rehabilitation, Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
Sponsor: National Taiwan University Hospital

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Cover Page 
Official Title： 
Evaluation of a Contextual, Behavioral, and Cognitive-Based Program to Improve 
Ophthalmic Compliance in Children and Adolescents with Special Needs 
 
NCT Number： 
NCT06717282 
 
Study Type: Interventional (Single-arm, Pre–Post) 
Version: Final 
Date: 2026-01-19 
 
 

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Study Protocol and Statistical Analysis Plan 
1. Background and Rationale 
Children and adolescents with special needs, including autism spectrum disorder, 
developmental delay, and intellectual disability, present a significantly higher prevalence of 
visual problems compared with typically developing peers. Early ophthalmic assessment and 
regular follow-up are essential; however, cooperation during ophthalmic examinations 
remains a major barrier. Sensory hypersensitivity, motor limitations, attentional difficulties, 
and cognitive challenges frequently prevent completion of standard ophthalmic assessments. 
Clinical experience and prior evidence suggest that structured interventions integrating 
contextual familiarization, behavioral reinforcement, and task-oriented cognitive support may 
improve cooperation during ophthalmic examinations and enhance participants’ ability to 
complete examinations that require higher levels of cognitive engagement. 
This study therefore evaluates a contextual, behavioral, and cognitive–based ophthalmic 
adaptation program designed to enhance ophthalmic compliance in children and adolescents 
with special needs. 
2. Study Objectives 
To evaluate the effectiveness of a contextual, behavioral, and cognitive–based ophthalmic 
adaptation program in improving cooperation during ophthalmic examinations and visual 
functional performance following the intervention. 
3. Study Design 
This study is a single-arm, pre–post interventional clinical trial. All eligible participants 
receive the intervention. Outcomes are assessed before and after completion of the 
intervention. Participants with complete pre- and post-intervention data are included in the 
final analysis. 
4. Study Setting 
Recruitment and assessments are conducted at the Vision Center for People with Special 
Needs, National Taiwan University Hospital. 
5. Participants 
Inclusion Criteria 
Participants must meet all the following criteria: 
(1) Aged 2 to 18 years. 
(2) Diagnosed with or suspected of autism spectrum disorder, developmental delay, or 
intellectual disability. 
(3) Demonstrated difficulty cooperating with routine ophthalmic examinations in general 
ophthalmology settings due to cognitive, behavioral, or emotional factors. 

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Exclusion Criteria 
Participants will be excluded if they meet the following criterion: 
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Children or adolescents with developmental delays or disabilities who can complete 
routine ophthalmic examinations or standard vision screenings during regular 
ophthalmology visits or school-based health screenings without specialized support. 
6. Sample Size and Analysis Population 
A total of 20 participants are enrolled. Participants with complete pre- and post-intervention 
outcome data are included in the final statistical analysis. 
7. Study Procedures 
Baseline Assessment 
Before intervention, participants undergo assessment using: 
(1) Visual Function Battery for Children with Special Needs (VFB-CSN) 
(2) Near Detection Scale (NDS) 
(3) Functional Vision Questionnaire (FVQ) 
(4) Ophthalmic Compliance and Adaptation Questionnaire 
(5) Parent-reported measures (Vineland Adaptive Behavior Scales–III, CASD-C, Sensory 
Profile, HVFQI) 
Intervention 
Participants receive six individual one-hour sessions, typically once every two weeks, 
delivered by occupational therapists specialized in visual rehabilitation. Intervention 
components include: 
(1) Contextual strategies (environmental familiarization) 
(2) Behavioral strategies (positive reinforcement) 
(3) Cognitive strategies (visual supports and structured instruction) 
Post-intervention Assessment 
All baseline outcome measures are re-administered following completion of the intervention. 
8. Outcome Measures 
Primary Outcome 
Change in overall visual functional performance (VFB-CSN). 
Secondary Outcomes 
Change in ophthalmic examination compliance as measured by the Ophthalmic Compliance 
and Adaptation Questionnaire. 
9. Statistical Considerations 
9.1 Analysis Population 
The analysis population includes participants who completed both pre-intervention and post-

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intervention assessments. Participants with incomplete outcome data were excluded from the 
final statistical analysis. 
9.2 Outcome Measures 
Primary Outcome 
Change in overall visual functional performance and subscale scores as measured by the 
Visual Function Battery for Children with Special Needs (VFB-CSN). 
Secondary Outcome 
Change in ophthalmic examination compliance as measured by the Ophthalmic Compliance 
and Adaptation Questionnaire. 
9.3 Descriptive Statistics 
Descriptive statistics are used to summarize participant demographic characteristics and 
baseline clinical measures. Continuous variables are presented as means and standard 
deviations, and categorical variables are presented as frequencies and percentages, as 
appropriate. 
9.4 Inferential Statistical Analysis 
Given the small sample size and the expected non-normal distribution of outcome measures, 
non-parametric statistical tests are used to compare pre-intervention and post-intervention 
outcomes. 
Comparisons between pre- and post-intervention scores for the primary and secondary 
outcomes are conducted using appropriate non-parametric methods for paired data. 
9.5 Significance Level 
All statistical tests are two-tailed. Statistical significance is defined as a p-value of less than 
0.05. 
9.7 Statistical Software 
All statistical analyses are performed using standard statistical software (e.g., SPSS). 
10. Ethics and Human Subjects Protection 
This study was reviewed and approved by the Institutional Review Board. Written informed 
consent was obtained from caregivers prior to participation. 
11. Data Management and Confidentiality 
All data are de-identified and securely stored. Access is restricted to authorized research 
personnel. 
12. Consistency Statement 
This protocol represents the final version reviewed and approved prior to data analysis. All 
analyses are conducted in accordance with the predefined Statistical Analysis Plan.