改善自闭症谱系障碍儿童的牙科护理和口腔健康
2026年5月19日 更新者：Coleen Cunningham、University of California, Irvine
一项随机对照试验（现场）比较已建立的 AIR-P Dental Toolkit（对照条件）与涉及 Dental Toolkit 和家长介导的行为干预（干预条件）的联合方案在改善家庭牙科护理、口腔健康结果方面的功效和牙科诊所访问经验。
研究概览
详细说明
由于多种因素，包括与 ASD 症状相关的考虑因素以及相关的焦虑和行为困难，参与常规牙科护理对患有自闭症谱系障碍 (ASD) 的儿童来说是一项重大挑战。 缺乏常规、有效的牙科护理导致 ASD 儿童的医疗保健需求未得到满足，他们患上过多牙菌斑、龋齿和口腔感染的风险增加。
本研究的目的是测试旨在改善自闭症谱系障碍儿童的家庭牙齿卫生、牙科诊所就诊依从性和口腔健康结果的家长培训干预措施。 将招募现诊断为 ASD 的儿童家庭参与。 所有家庭都将收到自闭症身体健康干预研究网络 (AIR-P) 牙科工具包，该工具包旨在为家长提供有关 ASD 儿童牙科护理和支持策略的指导和信息。 一些家庭还将参加为期 10 周的家长行为培训干预，重点是改善家庭牙科护理和牙科诊所就诊体验。
研究类型
介入性
注册 (实际的)
119
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Irvine、California、美国、92705
- University of California Irvine
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Ohio
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Columbus、Ohio、美国、43081
- Nationwide Children's Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3年 至 13年 (孩子)
接受健康志愿者
不
描述
纳入标准：
- 拥有 3 至 13 岁零 11 个月儿童的英语家庭。
- 基线评估确认的当前 ASD 诊断。
- 家长报告难以参与牙科护理。
- 确认在过去 6 个月内没有进行牙科筛查或检查/就诊。
- 医疗补助资格定义的服务不足状态。
排除标准：
- 患有需要紧急治疗的急性牙科疾病的儿童。
- 目前正在服用或最近停用会影响口腔和牙龈健康的药物的儿童。
- 站点首席研究员认为，由于无法或拒绝遵守试验程序和后续行动，会使受试者处于不必要的风险或实质上减少他们对试验目标的贡献的任何事情。
将要求家庭不要参与任何非研究适应性行为干预或专注于牙齿卫生的治疗。 还将要求家庭在调查期间不要参加任何非研究牙科筛查或检查。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：AIR-P 牙科工具包
家庭将获得自闭症身体健康干预研究网络 (AIR-P) 牙科工具包。
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AIR-P 牙科工具包旨在为护理人员提供有关自闭症谱系障碍儿童牙科护理和支持策略的指导和信息。
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实验性的：Parent Training
Families randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and individual behavioral parent training comprised of 7 core in-person sessions, including a home visit and a dental office coach, and 4 phone booster sessions.
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AIR-P 牙科工具包旨在为护理人员提供有关自闭症谱系障碍儿童牙科护理和支持策略的指导和信息。
家长培训干预措施整合了有效的策略：1) 提高对牙科护理的依从性，2) 增强具有神经典型发育和高度牙科恐惧的儿童的牙科体验，以及 3) 为患有牙科疾病的儿童建立基于证据的行为技术自闭症谱系障碍。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Frequency of Tooth Brushing at Home
大体时间：Difference in brushing frequency between Baseline and 6 months
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Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
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Difference in brushing frequency between Baseline and 6 months
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Frequency of Tooth Brushing at Home
大体时间：Difference in brushing frequency between Baseline and 3 months
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Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
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Difference in brushing frequency between Baseline and 3 months
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Child Oral Health According to Standardized Measures From Visual Exam
大体时间：Difference in oral health between Baseline and 6 months
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Dentist ratings of child oral health according to standardized measures from visual exam.
Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface).
Higher scores index greater visual plaque.
VPI Score =Total Score (Max + Mand) / # Surfaces Examined
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Difference in oral health between Baseline and 6 months
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Child Oral Health According to Standardized Measures From Visual Exam
大体时间：Difference in oral health between Baseline child and 3 months
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Dentist ratings of child oral health according to standardized measures from visual exam.
Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface).
Higher scores index greater visual plaque.
VPI Score =Total Score (Max + Mand) / # Surfaces Examined
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Difference in oral health between Baseline child and 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Child Behavior During Tooth Brushing at Home According to Questionnaire
大体时间：Difference in child behavior between Baseline and 6 months
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Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.
Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem).
Higher scores index greater behavior problems during home oral hygiene.
Items were averaged to produce a single score (α = 0.91).
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Difference in child behavior between Baseline and 6 months
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Child Behavior During Tooth Brushing at Home According to Questionnaire
大体时间：Difference in child behavior between Baseline and 3 months
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Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire.
Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem).
Higher scores index greater behavior problems during home oral hygiene.
Items were averaged to produce a single score (α = 0.91).
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Difference in child behavior between Baseline and 3 months
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Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
大体时间：Difference in Caries between Baseline and 6 months
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Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT) to document the presence and progression of fullmouth caries.
The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).
The scale is from 0 to 32, with 32 being the worst score.
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Difference in Caries between Baseline and 6 months
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Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
大体时间：Difference in Caries between Baseline and 3 months
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Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries.
The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).The scale range is 0-32 with 32 being worse.
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Difference in Caries between Baseline and 3 months
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Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
大体时间：Difference in decayed teeth between baseline to 6 months
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Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries.
The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).
The d2/D2 code represents clinically detectable cavitated lesions.
The scale range is 0-32 with 32 being worse.
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Difference in decayed teeth between baseline to 6 months
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Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
大体时间：Difference in decayed teeth between baseline and 3 months
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Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries.
The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).
The d2/D2 code represents clinically detectable cavitated lesions.
The scale range 0-32 with 32 being worse.
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Difference in decayed teeth between baseline and 3 months
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Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)
大体时间：Difference in anxiety and behavior between Baseline and 6 months
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Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite).
The scale is 0-5, 5 representing worse.
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Difference in anxiety and behavior between Baseline and 6 months
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Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire
大体时间：Difference in behavioral compliance between baseline and at 6 months
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Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire.
Dentists reported on the occurrence and severity of 8 behavior problems during the dental visit (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem).
Items were averaged to produce a single score.
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Difference in behavioral compliance between baseline and at 6 months
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Completion of Dental Visit Procedures According to Questionnaire
大体时间：Difference between completion of dental visit procedures at baseline and at 6 months
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Dentist-reported completion of visit procedures according to questionnaire (severity of behavior during visit procedures).
Behavior problems rated using a 0 to 9 scale (0 = no problem, 9 = severe problem).
9 represents a worse outcome.
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Difference between completion of dental visit procedures at baseline and at 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Family Impact Questionnaire (FIQ)
大体时间：Difference in parent-reported parenting stress at baseline and at 6 months
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Parenting stress associated with parenting the target autistic child.
Negative Impact Composite range 0-82; higher scores index greater parenting stress.
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Difference in parent-reported parenting stress at baseline and at 6 months
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Parenting Sense of Competence Scale (PSOC)
大体时间：Difference in parent-reported perceived parenting competence between baseline and 6 months
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Parent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy.
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Difference in parent-reported perceived parenting competence between baseline and 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Robin Steinberg-Epstein, MD、University of California, Irvine
- 首席研究员：Rachel M Fenning, PhD、University of California-Irvine; California State University-Fullerton
- 首席研究员：Eric Butter, PhD、Nationwide Children's Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年12月1日
初级完成 (实际的)
2019年6月1日
研究完成 (实际的)
2019年6月1日
研究注册日期
首次提交
2016年12月20日
首先提交符合 QC 标准的
2016年12月23日
首次发布 (估计的)
2016年12月26日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年5月19日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
自闭症谱系障碍的临床试验
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Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
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