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OpenTrials
Completed

NCT Number: NCT01116726

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

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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Key information

Age range

15 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Decayed,missing, and filled tooth surfaces (dmfs)

    Time frame: Over 3 years

Secondary outcomes

  1. Dental knowledge, attitudes, and behaviors of the mothers

    Time frame: Over 3 years

  2. Dental caries patterns of the children

    Time frame: Over 3 years

  3. Costs of dental care

    Time frame: Up to 3 years after randomization

  4. Other decayed, missing, and filled tooth surfaces measures

    Time frame: Over 3 years

    ds, % of children with dmfs and ds >0

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
May 5, 2010
Registry last updated
Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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