Influence of Financial Incentives on Oral Disease Management in Young Children: A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Mean number of qualifying half-day toothbrushing episodes per week
研究概览
简要总结
This Phase I randomized pilot trial will assess the efficacy of a fixed incentive payment program and drawing incentive payment program versus a control program to promote early childhood caries (ECC) preventive health behaviors (i.e., toothbrushing performance and dental visit attendance) for young children of predominantly Latino parents/caregivers enrolled in/waitlisted for Early Head Start (EHS) home visit programs.
详细描述
If both groups are acceptable and feasible, the reward group with toothbrushing outcomes at least 20% better than the other one (and the control) will be chosen for a future Phase II/III trial; if they are similar, the fixed monetary reward will be used because it is simpler to explain, monitor, and implement.
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 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Known allergic reaction to components of the study product(s).
- •Uncooperative or behaviorally unsuited (assessed during a TB prophylaxis at the initial baseline study visit).
- •A sibling of a child already 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.
研究组 & 干预措施
Fixed Incentive
Eligible to earn a weekly payment during the 2-month incentive intervention period. Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will win $5; high adherence threshold (brushing twice per day for 14 days in a week) will win $10.
干预措施: Fixed Incentive (Behavioral)
Drawing Incentive
Eligible to earn a weekly drawing entry with different winning probabilities during the 2-month incentive intervention period. Possible weekly winnings depend on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app: 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 2-months, but information on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app. After the Month 2 follow-up visit, may opt to participate in a delayed 2-month open label extension to earn the same monetary rewards the fixed incentive intervention group could earn Baseline through Month 2. 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
Mean number of qualifying half-day toothbrushing episodes per week
时间窗: Baseline visit through the Month 2 visit
Mean 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.)
Proportion of parents/caregivers attending a dental visit
时间窗: Month 2 visit
In the subset of children at baseline with no dental visit in the EHS ChildPlus health module, whether or not the child has a ChildPlus documented dental visit at the two-month follow-up.
次要结局
- Fluoridated toothpaste use(Baseline visit through the Month 2 visit)
- Proportion of weeks the parent/caregiver synced toothbrushing data with the app(Baseline visit through Month 2 visit)
- Mean number of days per week with parent/caregiver-reported twice daily brushing(Baseline visit through the Month 2 visit)
- Proportion of parents/caregivers who consent(Baseline visit)
- Proportion of parents/caregivers adhering to study procedures(Baseline visit through the Month 2 visit)
- Proportion of parents/caregivers willing to use the toothpaste pump(Baseline visit through the Month 2 visit)
- Feasibility of syncing toothbrush to app(Baseline visit)
- Proportion of parents/caregivers willing to be randomized(Baseline visit)
- Proportion of parents/caregivers willing to use photographs for central assessment(Baseline visit and Month 2 visit)
- Comfort with smart powered toothbrush(Baseline visit through Month 2 visit)
- EHS site participation(Month 0)
- EHS staff participation(Month 0)
- Feasibility of measuring toothbrushing frequency with diaries(Month 2 visit)
- Feasibility of using toothpaste pump weight as a measure of usage(Month 2 visit)
- Proportion of parents/caregivers willing to use the disclosing solution(Baseline visit and Month 2 visit)
- Proportion of parents/caregivers willing to use smart powered toothbrush(Baseline visit through Month 2 visit)
- Proportion of parents/caregivers willing to use smartphone app(Baseline visit)
- Child plaque score(Month 2 visit)
- Proportion of children who cooperate(Baseline visit through the Month 2 visit)
- Proportion of parents/caregivers willing to receive text messages(Baseline visit)