Promoting Behavioral Change for Oral Health in American Indian Mothers and Children

Not Applicable

Completed

• Conditions: Early Childhood Dental Caries

• Registration Number: NCT01116726
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-05
• Study Start: 2011-08
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-06
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1134

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 exclusion criteria. Although expected to be rare, if the father is a sole caregiver, he and his child will be eligible for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decayed,missing, and filled tooth surfaces (dmfs)	Over 3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States