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临床试验/NCT06717282
NCT06717282已完成不适用

Evaluation of a Contextual, Behavioral, and Cognitive-based Program to Improve Ophthalmic Compliance in Children and Adolescents With Special Needs

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Visual Function Battery for Children With Special Needs (VFB-CSN)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Intervention to improve ophthalmic compliance

Experimental

干预措施: visual rehabilitation for ophthalmic compliance (Behavioral)

Intervention to improve ophthalmic compliance

Experimental

干预措施: Using contextual, behavioral, and cognitive-based stragegies to develop training programs (Behavioral)

结局指标

主要结局

Visual Function Battery for Children With Special Needs (VFB-CSN)

时间窗: 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.

次要结局

  • Ophthalmic Visit Adaptation Questionnaire(Baseline (pre-intervention) and post-intervention (within 6 months).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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