Visual RehabilitationNCT06717282
Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents With Special Needs
A study testing visual rehabilitation for ophthalmic compliance and Using contextual, behavioral, and cognitive-based stragegies to develop training programs in people with Visual Rehabilitation and Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Visual Rehabilitation, Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
- What is being tested?
- visual rehabilitation for ophthalmic compliance and Using contextual, behavioral, and cognitive-based stragegies to develop training programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2024to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Occupational Therapy, College of Medicine, National Taiwan University
Taipei
About this study
Official title: 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:
Read more
"Does this structured program increase ophthalmic examination compliance in children and adolescents with special needs?"
Participants will:
- Attend six individualized training sessions (one session every two weeks, each lasting one hour)
- Engage in activities to practice and enhance cooperation during ophthalmic examination
- Undergo pre- and post-program assessments to measure visal function, behavioral adaptation, and other intervention outcomes.
Read the 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:
- 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.
- 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.
- Parental Involvement: Parents will be engaged throughout the intervention to ensure continuity of training at home.
Quality assurance plan :
- Regular site monitoring and auditing will be conducted to maintain data quality and protocol adherence.
- Systematic checks will compare collected data against predefined ranges and consistency rules, ensuring reliability.
- 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.
- Conditions
- Visual Rehabilitation, Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
- Being tested
- visual rehabilitation for ophthalmic compliance, Using contextual, behavioral, and cognitive-based stragegies to develop training programs
- Keywords
- Visual rehabilitation, Special need, Compliance, Ophthalmic examination
- Medical subject headings
- Vision Disorders, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual rehabilitation for ophthalmic complianceBehavioural
contextual, behavioral, and cognitive-based program for ophthalmic compliance
Using contextual, behavioral, and cognitive-based stragegies to develop training programsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention to improve ophthalmic compliance | Experimental | Not described Receives: Behavioral: visual rehabilitation for ophthalmic compliance; Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention and post-intervention (within 6 months)
Secondary outcomes (1)
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).
Measured: Baseline (pre-intervention) and post-intervention (within 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start15 Dec 2024
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Visual RehabilitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717282
- Sponsor's protocol ID
- 202410102RINB
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2024
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Contextual, Behavioral, and Cognitive-based Program to Improve Ophthalmic Compliance in Children and Adolescents With Special Needs
- ClinicalTrials.gov ID
- NCT06717282
- Acronym / sponsor ID
- 202410102RINB
- Conditions
- Visual Rehabilitation, Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
- Keywords
- Visual rehabilitation, Special need, Compliance, Ophthalmic examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Attend six individualized training sessions (one session every two weeks, each lasting one hour)
- Engage in activities to practice and enhance cooperation during ophthalmic examination
- Undergo pre- and post-program assessments to measure visal function, behavioral adaptation, and other intervention outcomes.
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:
- 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.
- 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.
- Parental Involvement: Parents will be engaged throughout the intervention to ensure continuity of training at home.
Quality assurance plan :
- Regular site monitoring and auditing will be conducted to maintain data quality and protocol adherence.
- Systematic checks will compare collected data against predefined ranges and consistency rules, ensuring reliability.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention to improve ophthalmic compliance | Experimental | Behavioral: visual rehabilitation for ophthalmic compliance, Behavioral: Using contextual, behavioral, and cognitive-based stragegies to develop training programs |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual rehabilitation for ophthalmic compliancecontextual, behavioral, and cognitive-based program for ophthalmic compliance | Behavioural | Intervention to improve ophthalmic compliance |
| Using contextual, behavioral, and cognitive-based stragegies to develop training programsKey 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. | Behavioural | Intervention to improve ophthalmic compliance |
Primary outcome
Visual Function Battery for Children With Special Needs (VFB-CSN)
Time frame: Pre-intervention and post-intervention (within 6 months)
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.
1 secondary outcome
Ophthalmic Visit Adaptation Questionnaire
Time frame: Baseline (pre-intervention) and post-intervention (within 6 months).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual rehabilitation for ophthalmic compliance and Using contextual, behavioral, and cognitive-based stragegies to develop training programs in people with Visual Rehabilitation and Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Function Battery for Children With Special Needs (VFB-CSN) (time frame: Pre-intervention and post-intervention (within 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.