Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,134
- 试验地点
- 2
- 主要终点
- Decayed,missing, and filled tooth surfaces (dmfs)
研究概览
简要总结
A program of motivational interviewing plus enhanced community services in prevention of early childhood caries vs. enhanced community services alone for American Indian mothers and their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure over a 3-year period.
详细描述
This is a randomized, controlled clinical trial. Six hundred mothers and their children will be randomized over a 2-year period to motivational interviewing (MI) plus enhanced community services vs. enhanced community services alone in equal numbers in the 2 groups. The MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries (ECC), shortly after childbirth and at 6, 12, and 18 months. The enhanced community services will involve development of culturally appropriate messages related to the mitigation of risk factors for ECC through public announcements and simple brochures. The primary outcome measure will be decayed, missing, and filled tooth surfaces (dmfs) of the children at ages 1, 2, and 3. Secondary outcomes will include children's ds, % with dmfs and ds >0, mother's dental knowledge, attitudes, and behaviors, caries patterns, and costs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 44 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be American Indian, as defined by the tribe
- •Be mothers or caregivers of newborn children
- •At least 15-44 years of age (Minors who are 15-17 years of age must get consent from a parent or legal guardian according to Tribal, State, and IHS rules and regulations)
- •Able to read, understand, and sign a consent form/assent form,
- •Be willing and able to follow study procedures and instructions.
排除标准
- •No exclusion criteria. Although expected to be rare, if the father is a sole caregiver, he and his child will be eligible for the study.
结局指标
主要结局
Decayed,missing, and filled tooth surfaces (dmfs)
时间窗: Over 3 years
次要结局
- Dental knowledge, attitudes, and behaviors of the mothers(Over 3 years)
- Dental caries patterns of the children(Over 3 years)
- Costs of dental care(Up to 3 years after randomization)
- Other decayed, missing, and filled tooth surfaces measures(Over 3 years)