BEhavioral EConomics for Oral Health iNnovation Trial

Study Overview
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Brief Summary
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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.

Official Title
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Influence of Financial Incentives on Oral Disease Management in Young Children

Conditions
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Toothbrushing, Dental Plaque, Parent-Child Relations, Oral Hygiene, Dental Caries

Intervention / Treatment
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* Behavioral: Drawing Incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child 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 Exclusion Criteria: Child 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 47 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible consenting parent-child participant dyads, within strata and permuted blocks, will be randomized in equal allocation to one of two arms. Strata will be based on site and smartphone operating system (iOS or Android).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incentive Drawing<br>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). | Behavioral: Drawing Incentive<br>* The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.<br>|
| No Intervention: Control - Delayed Incentive<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toothbrushing performance | 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.) | Baseline visit through the Month 6 visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term (immediate) toothbrushing performance | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | Baseline visit through the Month 1 visit | 
| Mid-term toothbrushing performance | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | Baseline visit through the Month 3 visit | 
| Toothbrushing performance sustainability | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. | Month 6 visit through the Month 12 visit | 
| Cost-effectiveness ratio | Short- and long-term incremental cost effectiveness ratios (ICERs) improving parent/caregiver toothbrushing performance relative to cost | 1, 2, 5, 10, and 20 years | 
| Cost-effectiveness return on investment | Short- and long-term return on investment (ROI) comparing intervention program costs versus future treatment costs averted | 1, 2, 5, 10, and 20 years | 
| Self-efficacy scale | Oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.) | Baseline visit through Month 6 visit | 
| Modified Simplified Oral Hygiene Index | Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores) | Month 6 visit and Month 12 visit | 
| Change from Baseline in toothpaste weight | Change in toothpaste pump weight (grams) from each distribution visit (6 months prior) | From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit | 
| Untreated caries | Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) untreated caries status (dt>0) | Month 6 visit and Month 12 visit | 
| Caries experience | Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) caries experience status (dmft>0) | Month 6 visit and Month 12 visit | 
| Severe caries | Binary measure of Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) severe caries experience status (dmft>=4) | Month 6 visit and Month 12 visit | 
| Past year dental visit | Binary measure of a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records annual dental visit and other required health screenings | Month 6 visit and Month 12 visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics