BEhavioral EConomics for Oral Health iNnovation Pilot Trial (NCT03862443) | Clinical Trial Compass
CompletedNot Applicable
BEhavioral EConomics for Oral Health iNnovation Pilot Trial
United States36 participantsStarted 2017-05-10
Plain-language summary
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.
Who can participate
Age range
6 Months – 42 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for 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 visit.
* Male or female, aged 18 and older.
* Speak, read, and write either English or Spanish.
* Be a parent or caregiver of a child at least 6 months old but less than 3.5 years (42 months), with at least 2 fully erupted teeth and enrolled in, or waitlisted for, one of the three participating Los Angeles County EHS home visit programs.
* Not be planning to move residence for the next 6 months outside the greater Los Angeles area.
* Own a smartphone with the Google Play or iTunes store and be willing to download the smart powered TB app
* Be willing to be contacted via text-messaging (SMS) for study related notifications, such as incentives earned or reminders to sync the TB
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean number of qualifying half-day toothbrushing episodes per week
Timeframe: Baseline visit through the Month 2 visit
2
Proportion of parents/caregivers attending a dental visit