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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Early Childhood Dental Caries

Treatments: Behavioral: Enhanced community services; Behavioral: Motivational interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01116726

08-0894

1U54DE019259 (U.S. NIH Grant/Contract)

09-004E (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,134 patients

Sex: All

Ages: 15 to 44 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,134 participants in 2 patient groups

Motivational interviewing and enhanced community services

Experimental group

Description:

Motivational interviewing sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries, provided shortly after childbirth, and at 6, 12, and 18 months. Enhanced community services will involve development of culturally appropriate messages related to the mitigation of risk factors for ECC through public service announcements and brochures.

Treatment:

Behavioral: Enhanced community services

Behavioral: Motivational interviewing

Enhanced community services

Active Comparator group

Description:

Enhanced community services will involve development of culturally appropriate messages related to the mitigation of behavioral risk factors for early childhood caries through public service announcements and brochures.

Treatment:

Behavioral: Enhanced community services