Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Plaque Index Scoring
研究概览
简要总结
There is a need to find an approach that is appropriate for managing children with Autism Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety in this research we will apply our modified dental visual aids and test its effectiveness in managing the behavior of such children during the dental appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between 6-10 years.
- •Child patient has to represent the typical triad symptoms of ASD that include: social interaction deficits, communication impairment, language impairment and rigidity of interests.
- •Child patient with ASD diagnosis confirmed in the patient's files according to "the DSM-V criteria" (American Psychiatric Association, 2013).
- •Child patient with mild to moderate ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
排除标准
- •Patient age younger than 6 years and older than 10 years.
- •Child patient with other congenital anomalies, for example, "Cerebral Palsy" or "Down Syndrome".
- •Child patient with previous dental experience.
- •Child patient with severe ASD according to "the Childhood Autism Rating Scale (CARS)" (Schopler et al., 1998).
结局指标
主要结局
Plaque Index Scoring
时间窗: four weeks
plaque index scoring (Silness and Löe, 1964)
Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD)
时间窗: four weeks
This scale contains twenty-four "self-report" questions that inquire about anxiety, it contains 4 sub-scales including: 1. Separation Anxiety (SA). 2. Uncertainty (U). 3. Performance Anxiety (PA). 4. Anxious Arousal (AA). It is a four-point "Likert-scale"; items in the questionnaire are rated from zero ("never") to three ("always"). Another version of the same scale with twenty-four questions directed to the parents will also be used and it contains a report of their child's symptoms of anxiety, within the same four subscales (Rodgers et al., 2016).
The Observational Scale of Behavioral Distress (OSBD)
时间窗: four weeks
This scale is used to measure the behavioral distress that a child experiences when undergoing a painful procedure. This scale is composed of eight operationally defined behaviors that are indicative of anxiety and/or pain behavior in children. The OSBD is a valid and reliable scale that measures distress in children receiving painful procedures in the medical and dental practice, for example, venipuncture and needle injections (Elliot et al., 1987).
次要结局
未报告次要终点
研究者
Ala Aljubour
Principal Investigator
King Abdulaziz University