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

Early Childhood Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116726
• Other study ID #: 08-0894
• Secondary ID: 09-004E1U54DE019
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: January 2017

Study information

• Verified date: July 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Early Childhood Dental Caries
• Problem Behavior

Intervention

Behavioral:
• Motivational interviewing
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
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.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Batliner T, Fehringer KA, Tiwari T, Henderson WG, Wilson A, Brega AG, Albino J. Motivational interviewing with American Indian mothers to prevent early childhood caries: study design and methodology of a randomized control trial. Trials. 2014 Apr 14;15:125. doi: 10.1186/1745-6215-15-125. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decayed,missing, and filled tooth surfaces (dmfs)		Over 3 years
Secondary	Dental knowledge, attitudes, and behaviors of the mothers		Over 3 years
Secondary	Dental caries patterns of the children		Over 3 years
Secondary	Costs of dental care		Up to 3 years after randomization
Secondary	Other decayed, missing, and filled tooth surfaces measures	ds, % of children with dmfs and ds >0	Over 3 years