BEhavioral EConomics for Oral Health iNnovation Trial

University of California, San Francisco244 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

244

Conditions

Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene Dental Caries

Interventions

Drawing IncentiveBEHAVIORAL

The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 47 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Venice Family Clinic Children First Early Head Start

Santa Monica, California, United States

Outcomes

Primary Outcomes

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.)

Time frame: Baseline visit through the Month 6 visit

Secondary Outcomes

Short-term (Immediate) Toothbrushing Performance

Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.

Time frame: 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.

Time frame: 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.

Time frame: Month 6 visit through the Month 12 visit

Self-efficacy Scale

Caregiver (parent) 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.)

Time frame: Month 6 visit

Modified Simplified Oral Hygiene Index

Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst)

Time frame: Month 6 visit and Month 12 visit

Data from ClinicalTrials.gov

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