University of Colorado Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT01116726
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.
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Notify Me15 year–44 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Over 3 years
Time frame: Over 3 years
Time frame: Over 3 years
Time frame: Up to 3 years after randomization
Time frame: Over 3 years
ds, % of children with dmfs and ds >0
University of Colorado, Denver
Other
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