Early Childhood Dental Caries
Conditions
Brief summary
A program of motivational interviewing plus enhanced community services in prevention of early childhood caries vs. enhanced community services alone for American Indian mothers and their children will reduce the childrens' decayed, missing, and filled tooth surfaces measure over a 3-year period.
Detailed description
This is a randomized, controlled clinical trial. Six hundred mothers and their children will be randomized over a 2-year period to motivational interviewing (MI) plus enhanced community services vs. enhanced community services alone in equal numbers in the 2 groups. The MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries (ECC), shortly after childbirth and at 6, 12, and 18 months. The enhanced community services will involve development of culturally appropriate messages related to the mitigation of risk factors for ECC through public announcements and simple brochures. The primary outcome measure will be decayed, missing, and filled tooth surfaces (dmfs) of the children at ages 1, 2, and 3. Secondary outcomes will include children's ds, % with dmfs and ds \>0, mother's dental knowledge, attitudes, and behaviors, caries patterns, and costs.
Interventions
BEHAVIORALMotivational interviewing
MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries. These will take place shortly after childbirth and at months 6, 12, and 18.
BEHAVIORALEnhanced community services
Enhanced community services will involve the development of culturally appropriate messages related to the mitigation of behavioral risk factors for early childhood caries through public service announcements and brochures.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Be American Indian, as defined by the tribe * Be mothers or caregivers of newborn children * At least 15-44 years of age (Minors who are 15-17 years of age must get consent from a parent or legal guardian according to Tribal, State, and IHS rules and regulations) * Able to read, understand, and sign a consent form/assent form, * Be willing and able to follow study procedures and instructions.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decayed,missing, and filled tooth surfaces (dmfs) | Over 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dental knowledge, attitudes, and behaviors of the mothers | Over 3 years | — |
| Dental caries patterns of the children | Over 3 years | — |
| Costs of dental care | Up to 3 years after randomization | — |
| Other decayed, missing, and filled tooth surfaces measures | Over 3 years | ds, % of children with dmfs and ds \>0 |
Countries
United States
Outcome results
None listed