Clinical trial NCT06717282: Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents with Special Needs
Official title: Evaluation of a Contextual, Behavioral, and Cognitive-based Program to Improve Ophthalmic Compliance in Children and Adolescents with Special Needs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Visual Rehabilitation
Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms
Keywords: Visual rehabilitation, Special need, Compliance, Ophthalmic examination
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. Attend six individualized training sessions (one session every two weeks, each lasting one hour)
2. Engage in activities to practice and enhance cooperation during ophthalmic examination
3. 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:

1. 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.
2. 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.
3. Parental Involvement: Parents will be engaged throughout the intervention to ensure continuity of training at home.

Quality assurance plan :

1. Regular site monitoring and auditing will be conducted to maintain data quality and protocol adherence.
2. Systematic checks will compare collected data against predefined ranges and consistency rules, ensuring reliability.
3. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Visual Function Battery for Children with Special Needs
timeFrame: 6 months
measure: Near Detection Scale
timeFrame: 6 months
measure: Functional Vision Questionnaire
timeFrame: 6 months
measure: Ophthalmic Visit Adaptation Questionnaire
timeFrame: 6 months
measure: Goal Attainment Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Occupational Therapy, College of Medicine, National Taiwan University
Study officials:
References: