Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in parental attitudes towards child tooth brushing and caries
研究概览
简要总结
"BeReady2Smile (BR2S)", based on successful results from the Phase I SBIR feasibility/usability research of the prototype, is a coordinated oral health prevention intervention program that provides empirically-supported behavioral parent training (BPT) skills and oral health instruction through the use of video and mobile/web- application. In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. The investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to our usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior.
The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.
详细描述
Primary Objective: Assess the efficacy of the BR2S intervention program in the context of established parenting education systems (e.g., Head Start and Oregon Parenting Education Collaborative). A sub-sample of participants will complete an observational interaction procedure as measured by The Dyadic Parent-Child Interactive Coding System.
Secondary Objectives:
- Assess relative contribution of BR2S components to outcomes to provide insight on options for dissemination using Usual Care Video only (UC control) or BeReady2Smile Video only or BeReady2Smile video + app or BeReady2Smile Video + app + coach.
- Assess aspects of user experience with the BR2S program
Primary Endpoint: This study will provide outcomes for a primary endpoints that will compare BeReady2Smile to comparison (usual care video) as measured by the Plaque Control Record. The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in the mouth. A tooth has 4 surfaces at the gum line being; the cheek side, tongue side, front side, and back side. A hygienist will disclose or stain up the Bacterial Plaque to show where one may be missing.
Secondary Endpoints: 1. With this study's data, additional secondary endpoints the investigators will investigate the effects of BeReady2Smile video alone and BeReady2Smile video + app compared to the usual-care video as well as the impact of a coach (Oral Health Educator). The investigators will also measure behavioral change, self-efficacy, establishment of dental home knowledge, and attitudes. 2. User experience will be measured by Coach Feedback, App feedback, and Video satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a child 0-6 years enrolled in a participating social service agency providing parent education, such as Head Start; be able to communicate in English or Spanish.
排除标准
- •Individuals who meet the following criteria will be excluded from the study:
- •Parental psychosis or other major mental illness or cognitive disability that would interfere with meaningful participation
- •Babies without teeth
- •Children with allergies to food dye.
结局指标
主要结局
Change in parental attitudes towards child tooth brushing and caries
时间窗: T1 (Baseline) and T3 (three month)
Four scales are included in the questionnaire that were developed for the international study of Adair and colleagues. Included in this study were: 1. 'Importance and Intention to Brush Child's Teeth' (five items), 2. 'Parental Efficacy in Relation to Child Tooth brushing' (6 items), 3. 'Perceived Seriousness of Tooth Decay in Children' (seven items) and 4. 'Chance Control - Decay Occurs by Chance' (5 items). Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
次要结局
- Knowledge(T1 (Baseline) and T3 (three month))
- Parents' confidence in brushing(T1 (Baseline) and T3 (three month))
- Connection to Dental Services "Dental Home"(T1 (Baseline) and T3 (three month))
- Clinical Dental Exam for Plaque(T1 (Baseline) and T3 (three month))
- Usage of Application(Once a week through study completion at 12 weeks)
- Satisfaction of Video and App(T2 (one month) and T3 (three month))
- Knowledge(T1 (Baseline) and T3 (three month))
- Parents' confidence in brushing(T1 (Baseline) and T3 (three month))
- Connection to Dental Services "Dental Home"(T1 (Baseline) and T3 (three month))
- Clinical Dental Exam for Plaque(T1 (Baseline) and T3 (three month))
- Usage of Application(Once a week through study completion at 12 weeks)
- Satisfaction of Video and App(T2 (one month) and T3 (three month))
- Direct observation of Parenting Behavior(T1 (Baseline) and T3 (three month))