Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Toothbrushing distribution
研究概览
简要总结
The goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. We have 2 specific aims:
- During the 2-year UG3 phase, we will use the Discover, Design+Build, and Test Framework to modify our existing app and pilot the intervention.
- During the 4-year UH3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes.
Participants will asked to use the app, complete surveys on REDCap, participate in feedback interviews and focus groups. Behavior change in the experimental group will be compared with that in the control group.
详细描述
Adolescents with autism are at increased risk for tooth decay in part because of poor diet and toothbrushing habits. Effective ways to reduce added sugar intake have yet to be tested, but technologies exist to help improve toothbrushing. Mobile health apps are a promising but underutilized way to improve and enforce toothbrushing habits. Many adolescents with autism are enamored with technology and own devices that support apps. We propose a Stage II efficacy trial in modifying a toothbrushing app and inform behavior change in the target population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The Investigator and Outcomes Assessor will be blinded to allocation. Both arms will be described as interventions (educational versus behavioral). At the end of the trial children will be able to access the app in the other arm free of charge. The Outcomes Assessor (Statistician) will be masked to group assignment and unblinded only after the final analyses are completed.
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child participants will have Autism Spectrum Disorder that will be confirmed by: (1) chart review by clinical staff at the recruitment sites to determine if the child meets the DSM-5 criteria for autism spectrum disorder; OR (2) affirmative caregiver response (YES) to the question, "Has a healthcare provider ever diagnosed your child with autism?"
- •Willingness to take a CARS-2 [Childhood Autism Rating Scale-2], which will be administered by trained staff
- •Child brushes independently [The child needs to be able to hold the toothbrush and move it around their teeth, mostly unassisted]
- •Child uses touch screen devices (e.g.,smartphones or tablet)
- •Ages 10 to 17 years at enrollment
- •Caregiver and child able to communicate in English
- •Caregiver age ≥18 years and able to provide informed consent in English
- •Child and caregiver live in the same home
- •Child has ready access to a mobile device with a front-facing camera onto which apps can be downloaded (iPad or iPhone with iOS 16.0+; Android tablet or phone with Android 13.0+)
- •Family has a Wi-Fi or cellular data plan to allow app data to be transmitted, with confirmation of via tools like the Ookla Speed Test to help problem solve and ensure that app data can be transmitted
排除标准
- •Children with autism younger than age 10 years will be excluded
结局指标
主要结局
Toothbrushing distribution
时间窗: 3 months
The primary outcome is toothbrushing distribution, defined as the mean proportion of total tooth surfaces in the mouth that are brushed during the last month of the 3-month trial.
次要结局
- Toothbrushing duration(3 months)
研究者
Donald Chi
Professor: School of Dentistry
University of Washington