Dental Caries, Dental Plaque, Oral Hygiene, Parent-Child Relations, Toothbrushing
Conditions
Keywords
Preventive Dentistry, Health Disparities, Health Behavior, Behavioral Economics
Brief summary
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.
Interventions
BEHAVIORALDrawing Incentive
The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
Sponsors
University of California, Los Angeles
National Institute of Dental and Craniofacial Research (NIDCR)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
6 Months to 47 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toothbrushing Performance | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid-term Toothbrushing Performance | Baseline visit through the Month 3 visit | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. |
| Toothbrushing Performance Sustainability | Month 6 visit through the Month 12 visit | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. |
| Self-efficacy Scale | Month 6 visit | 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.) |
| Modified Simplified Oral Hygiene Index | Month 6 visit and Month 12 visit | 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) |
| Short-term (Immediate) Toothbrushing Performance | Baseline visit through the Month 1 visit | Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. |
| Untreated Caries | Month 6 visit and Month 12 visit | Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt\>0) |
| Caries Experience | Month 6 visit and Month 12 visit | Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft\>0) |
| Severe Caries | Month 6 visit and Month 12 visit | Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft\>=4) |
| Past Year Dental Visit | Month 12 visit | Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings |
| Change From Baseline in Toothpaste Weight | From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit | Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time. |
Countries
United States
Participant flow
Pre-assignment details
Child-Parent Dyads were recruited and Dyad is the unit of analysis Protocol Enrollment number is the number of Dyads recruited, enrolled, and analyzed; total number of participants who Started the study is the number of Individual participants in the study (i.e., 2x number of dyads).
Participants by arm
| Arm | Count |
|---|---|
| Incentive Drawing: Children 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).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. | 122 |
| Incentive Drawing: Parents 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).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance. | 122 |
| Control - Delayed Incentive: Children 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. | 122 |
| Control - Delayed Incentive: Parents 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. | 122 |
| Total | 488 |
Baseline characteristics
| Characteristic | Incentive Drawing: Children | Incentive Drawing: Parents | Control - Delayed Incentive: Children | Control - Delayed Incentive: Parents | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 122 Participants | 0 Participants | 122 Participants | 1 Participants | 245 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 122 Participants | 0 Participants | 120 Participants | 242 Participants |
| Age, Continuous | 1.6 years STANDARD_DEVIATION 0.9 | 32.4 years STANDARD_DEVIATION 7 | 1.6 years STANDARD_DEVIATION 0.8 | 32.7 years STANDARD_DEVIATION 6.7 | 17.1 years STANDARD_DEVIATION 16.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 106 Participants | 106 Participants | 102 Participants | 102 Participants | 416 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 15 Participants | 20 Participants | 20 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 16 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 5 Participants | 0 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 77 Participants | 79 Participants | 82 Participants | 83 Participants | 321 Participants |
| Race (NIH/OMB) White | 33 Participants | 34 Participants | 25 Participants | 29 Participants | 121 Participants |
| Sex: Female, Male Female | 63 Participants | 117 Participants | 52 Participants | 114 Participants | 346 Participants |
| Sex: Female, Male Male | 59 Participants | 5 Participants | 70 Participants | 8 Participants | 142 Participants |
| Study Site Location A | 26 Participants | 26 Participants | 27 Participants | 27 Participants | 106 Participants |
| Study Site Location B | 87 Participants | 87 Participants | 90 Participants | 90 Participants | 354 Participants |
| Study Site Location C | 9 Participants | 9 Participants | 5 Participants | 5 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 0 | 0 / 122 | 0 / 0 |
| other Total, other adverse events | 3 / 122 | 0 / 0 | 5 / 122 | 0 / 0 |
| serious Total, serious adverse events | 0 / 122 | 0 / 0 | 0 / 122 | 0 / 0 |
Outcome results
Primary
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
Population: any post-baseline evaluable data from 0 to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Toothbrushing Performance | 4.6 qualifying half-day episodes per week | Standard Deviation 2.8 |
| Incentive Drawing: Parents | Toothbrushing Performance | 5.6 qualifying half-day episodes per week | Standard Deviation 3.3 |
Secondary
Caries Experience
Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft\>0)
Time frame: Month 6 visit and Month 12 visit
Population: Not all randomized children were available for evaluation at Month 6 and Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Caries Experience | Month 6 | 16 Participants |
| Control - Delayed Incentive: Parents | Caries Experience | Month 12 | 12 Participants |
| Incentive Drawing: Parents | Caries Experience | Month 12 | 18 Participants |
| Incentive Drawing: Parents | Caries Experience | Month 6 | 17 Participants |
Secondary
Change From Baseline in Toothpaste Weight
Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time.
Time frame: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visit
Population: Data were only available for participants who brought toothpaste tube back on follow-up visits at Month 6 and Month 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Delayed Incentive: Parents | Change From Baseline in Toothpaste Weight | Baseline to Month 6 | -44.9 grams | Standard Deviation 25.4 |
| Control - Delayed Incentive: Parents | Change From Baseline in Toothpaste Weight | Month 6 to Month 12 | -51.4 grams | Standard Deviation 32.5 |
| Incentive Drawing: Parents | Change From Baseline in Toothpaste Weight | Baseline to Month 6 | -40.9 grams | Standard Deviation 27.7 |
| Incentive Drawing: Parents | Change From Baseline in Toothpaste Weight | Month 6 to Month 12 | -48.0 grams | Standard Deviation 32.3 |
Secondary
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
Population: any post-baseline evaluable data from 0 to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Mid-term Toothbrushing Performance | 4.9 qualifying half-day episodes per week | Standard Deviation 3 |
| Incentive Drawing: Parents | Mid-term Toothbrushing Performance | 5.8 qualifying half-day episodes per week | Standard Deviation 3.4 |
Secondary
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
Population: Not all randomized children were available for evaluation at Month 6 and Month 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control - Delayed Incentive: Parents | Modified Simplified Oral Hygiene Index | Month 6 | 2.2 units on a scale | Standard Deviation 0.6 |
| Control - Delayed Incentive: Parents | Modified Simplified Oral Hygiene Index | Month 12 | 2.2 units on a scale | Standard Deviation 0.6 |
| Incentive Drawing: Parents | Modified Simplified Oral Hygiene Index | Month 6 | 2.1 units on a scale | Standard Deviation 0.5 |
| Incentive Drawing: Parents | Modified Simplified Oral Hygiene Index | Month 12 | 2.1 units on a scale | Standard Deviation 0.6 |
Secondary
Past Year Dental Visit
Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings
Time frame: Month 12 visit
Population: Data was not systematically recorded in the Early Head Start (EHS) ChildPlus database for individual child participants. EHS reports total number of visits per month but does not record that info for individuals in the EHS ChildPlus database.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control - Delayed Incentive: Parents | Past Year Dental Visit | 6 Participants |
| Incentive Drawing: Parents | Past Year Dental Visit | 5 Participants |
Secondary
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
Population: some participants did not complete the self-efficacy instrument at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Self-efficacy Scale | 26.4 score on a scale | Standard Deviation 2.6 |
| Incentive Drawing: Parents | Self-efficacy Scale | 25.9 score on a scale | Standard Deviation 3.1 |
Secondary
Severe Caries
Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft\>=4)
Time frame: Month 6 visit and Month 12 visit
Population: Not all randomized children were available for evaluation at Month 6 and Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Severe Caries | Month 6 | 3 Participants |
| Control - Delayed Incentive: Parents | Severe Caries | Month 12 | 3 Participants |
| Incentive Drawing: Parents | Severe Caries | Month 6 | 5 Participants |
| Incentive Drawing: Parents | Severe Caries | Month 12 | 5 Participants |
Secondary
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
Population: any post-baseline evaluable data from 0 to 1 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Short-term (Immediate) Toothbrushing Performance | 5.4 qualifying half-day episodes per week | Standard Deviation 3.2 |
| Incentive Drawing: Parents | Short-term (Immediate) Toothbrushing Performance | 6.2 qualifying half-day episodes per week | Standard Deviation 3.7 |
Secondary
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
Population: any post-baseline evaluable data from 6 to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Toothbrushing Performance Sustainability | 4.3 qualifying half-day episodes per week | Standard Deviation 2.6 |
| Incentive Drawing: Parents | Toothbrushing Performance Sustainability | 4.8 qualifying half-day episodes per week | Standard Deviation 3.3 |
Secondary
Untreated Caries
Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt\>0)
Time frame: Month 6 visit and Month 12 visit
Population: Not all randomized children were available for evaluation at Month 6 and Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control - Delayed Incentive: Parents | Untreated Caries | Month 6 | 14 Participants |
| Control - Delayed Incentive: Parents | Untreated Caries | Month 12 | 9 Participants |
| Incentive Drawing: Parents | Untreated Caries | Month 6 | 13 Participants |
| Incentive Drawing: Parents | Untreated Caries | Month 12 | 14 Participants |