Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 2
- 主要终点
- Dental Caries Increment
研究概览
简要总结
This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is < 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.
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 (Care Provider, Outcomes Assessor)
盲法说明
Outcome Assessors and Oral Health Examiners will be blind to treatment condition.
入排标准
- 年龄范围
- 0 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caregiver and child must meet all of the following:
- •Caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing
- •The child must receive medical care at one of the participating pediatric clinics.
- •Speak, understand, and read either English or Spanish
- •Have a mobile phone.
排除标准
- •If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study
- •Children with severe congenital tooth malformations: At screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta.
- •Children who cannot complete the baseline oral health exam.
结局指标
主要结局
Dental Caries Increment
时间窗: 24-month time point (oral assessment)
Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
Parent/Caregiver Confidence to Brush
时间窗: 4-month time point (survey)
9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)
Parent/Caregiver Motivation to Perform Oral Health Behaviors
时间窗: 4-month time point (survey)
A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
时间窗: 4-month time point (survey)
An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).
Self-efficacy to Perform Oral Health Behaviors
时间窗: 4-month time point (survey)
The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).
Dental Caries Increment (Surface Level)
时间窗: 24-month time point (oral assessment)
Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
次要结局
- Child Preventive Dental Visits(4-month, 12-month, and 24-month time points (survey))
- Child Diet - Beverage Intake(4-month, 12-month, and 24-month time points (survey))
- Satisfaction With Text Message Program Features(4-month time point (survey))
- Perceived Impact of OHT Program on Parental Awareness(24-month (survey))
- Child Tooth Brushing(4-month, 12-month, and 24-month time points (survey))
- Diffusion of Text Messages (Satisfaction)(4-month time point (survey))
- Fluoridated Toothpaste Use(4-month, 12-month, and 24-month time points (survey))
- Text Message Program Length Satisfaction(4-month time point (survey))
- Child Diet - Food Frequency(4-month, 12-month, and 24-month time points (survey))
- Child Oral Health-related Quality of Life(4-month, 12-month, and 24-month time points (survey))
- Parent/Caregiver Tooth Brushing(4-month, 12-month, and 24-month time points (survey))
- Parents' Perceived Impact of iSmile(4-month time point (survey))
- Parents/Caregivers Toothbrushing (Clinical Guidelines)(4-month, 12-month, and 24-month time points (survey))
- Child Toothbrushing (Clinical Guidelines)(4-month, 12-month, and 24-month time points (survey))
- Text Message Program Quality(4-month time point (survey))
- Text Message Program Star Rating(4-month time point (survey))