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

University of Colorado, Denver1,134 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,134

Conditions

Early Childhood Dental Caries

Interventions

Motivational interviewingBEHAVIORAL

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 servicesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Decayed,missing, and filled tooth surfaces (dmfs)

Time frame: Over 3 years

Secondary Outcomes

Dental knowledge, attitudes, and behaviors of the mothers

Time frame: Over 3 years

Dental caries patterns of the children

Time frame: Over 3 years

Costs of dental care

Time frame: Up to 3 years after randomization

Other decayed, missing, and filled tooth surfaces measures

ds, % of children with dmfs and ds \>0

Time frame: Over 3 years

Data from ClinicalTrials.gov

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