Influence of Financial Incentives on Oral Disease Management in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 2
- 主要终点
- Toothbrushing Performance
研究概览
简要总结
This Phase II stratified randomized prevention trial will assess the efficacy of a behavioral economic theory-based financial incentive drawing program versus a control regimen to promote early childhood caries (ECC) preventive health behaviors (toothbrushing performance) for young children of predominantly Latino parents/caregivers in Early Head Start (EHS) and day care center programs.
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
An independent outcomes assessor and PIs will be blinded to participants' group assignment, and participants will be told that the examiner and PIs cannot answer any incentive questions and they should not mention the incentive program to them. (Due to the nature of the intervention, the staff explaining the study arms after randomization and providing the incentive gift cards at follow-up visits cannot be blinded.)
入排标准
- 年龄范围
- 6 Months 至 47 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 2 fully erupted teeth
- •enrolled in, or waitlisted for, one of the participating Los Angeles County Early Head Start (EHS) or affiliated day care center or area clinic programs
- •Parent/caregiver
- •provide signed and dated informed consent form in English or Spanish
- •agree to comply with all study procedures and be available for the duration of the study
- •aged 18 or older
- •speak either English or Spanish and self-reported ability to read and write either English or Spanish
- •be a parent or caregiver of a child at least 6 months old but less than 4 years (48 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the participating Los Angeles County EHS or affiliated day care center or area clinic programs
- •not be planning to move residence for the next 18 months outside the greater Los Angeles area
- •own a smartphone with Google Play or iTunes store app and be willing to download and install the smart powered toothbrush app at the Screening visit and keep it installed for the duration of the project. [If the app cannot be properly installed by the baseline visit, the participant will not be randomized.]
- •be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the toothbrush
- •Stakeholder
- •be a staff member at a participating study site (e.g. EHS or affiliated day care center)
- •verbally agree to participate after being provided a study information sheet
排除标准
- •known allergic reaction to components of the study product(s)
- •uncooperative or behaviorally unsuited (assessed during a toothbrush prophylaxis, ASTDD Basic Screening Survey caries screening, and photograph of maxillary incisors at the screening visit)
- •more than 2 crowns on maxillary incisor teeth (teeth# D, E, F, G, or equivalently #52, 51, 61, 62).
- •participated in the BEECON pilot trial
- •a sibling of a child enrolled in the study (the family's oldest child in the eligible age range will be the study child)
- •enrolled in foster care
- •anything else that would place him/her at increased health risk or preclude the individual's full compliance with or completion of the study
- •Parent/caregiver
- •participated in the BEECON pilot trial
- •unable or unwilling to install and use the smart powered toothbrush app during the run-in period
研究组 & 干预措施
Incentive Drawing
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
干预措施: Drawing Incentive (Behavioral)
Control - Delayed Incentive
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
结局指标
主要结局
Toothbrushing Performance
时间窗: Baseline visit through the Month 6 visit
Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
Toothbrushing Performance
时间窗: Baseline visit through the Month 6 visit
Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
次要结局
- Untreated Caries(Month 6 visit and Month 12 visit)
- Caries Experience(Month 6 visit and Month 12 visit)
- Severe Caries(Month 6 visit and Month 12 visit)
- Past Year Dental Visit(Month 12 visit)
- Short-term (Immediate) Toothbrushing Performance(Baseline visit through the Month 1 visit)
- Mid-term Toothbrushing Performance(Baseline visit through the Month 3 visit)
- Toothbrushing Performance Sustainability(Month 6 visit through the Month 12 visit)
- Self-efficacy Scale(Month 6 visit)
- Modified Simplified Oral Hygiene Index(Month 6 visit and Month 12 visit)
- Change From Baseline in Toothpaste Weight(From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit)
- Short-term (Immediate) Toothbrushing Performance(Baseline visit through the Month 1 visit)
- Mid-term Toothbrushing Performance(Baseline visit through the Month 3 visit)
- Toothbrushing Performance Sustainability(Month 6 visit through the Month 12 visit)
- Self-efficacy Scale(Month 6 visit)
- Modified Simplified Oral Hygiene Index(Month 6 visit and Month 12 visit)
- Change From Baseline in Toothpaste Weight(From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit)
- Untreated Caries(Month 6 visit and Month 12 visit)
- Caries Experience(Month 6 visit and Month 12 visit)
- Severe Caries(Month 6 visit and Month 12 visit)
- Past Year Dental Visit(Month 12 visit)