Summary

for people ages 6 months to 47 months (full criteria)
healthy people welcome
at UCSF UCLA
study started
estimated completion:
Stuart Gansky (ucsf) Francisco Ramos-Gomez (ucla)

Description

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.

Official Title

Influence of Financial Incentives on Oral Disease Management in Young Children

Keywords

Toothbrushing Dental Plaque Parent-Child Relations Oral Hygiene Dental Caries Preventive Dentistry Health Disparities Health Behavior Behavioral Economics Drawing Incentive

Eligibility

You can join if…

Open to people ages 6 months to 47 months

  • 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

You CAN'T join if...

  • 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

Location

  • Venice Family Clinic Children First Early Head Start accepting new patients
    Santa Monica California 90405-1828 United States

Lead Scientists

  • Stuart Gansky (ucsf)
    I am Professor and Lee Hysan Chair of Oral Epidemiology in the School of Dentistry and Director (PI) of NIH-funded UCSF Center to Address Disparities in Children's Oral Health (CAN-DO). Previously, for more than 4 years, I was Director of the Data Coordinating Center for NIH-funded Early Childhood Caries Collaborative Centers at UCSF, University of Colorado Denver, and Boston University.
  • Francisco Ramos-Gomez (ucla)

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03576326
Study Type
Interventional
Last Updated