Promoting Behavioral Change for Oral Health in American Indian Mothers and Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Early Childhood Dental Caries	Behavioral: Motivational interviewing Behavioral: Enhanced community services	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Promoting Behavioral Change for Oral Health in American Indian Mothers and Children

Resource links provided by NLM:

MedlinePlus related topics: Dental Health Tooth Decay

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:

Decayed,missing, and filled tooth surfaces (dmfs) [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dental knowledge, attitudes, and behaviors of the mothers [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
Dental caries patterns of the children [ Time Frame: Over 3 years ] [ Designated as safety issue: No ]
Costs of dental care [ Time Frame: Up to 3 years after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	August 2011
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Motivational interviewing and enhanced community services 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.	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. Behavioral: 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.
Active Comparator: Enhanced community services 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.	Behavioral: 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.

Arms

Assigned Interventions

Experimental: Motivational interviewing and enhanced community services

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.

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.

Behavioral: 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.

Active Comparator: Enhanced community services

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.

Behavioral: 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.

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 mother's dental knowledge, attitudes, and behaviors, caries patterns, and costs.

Eligibility

Ages Eligible for Study:	15 Years to 44 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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, and 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116726

Locations

United States, Colorado
University of Colorado Denver	Recruiting
Aurora, Colorado, United States, 80045
Contact: Terry Batliner, DDS,MBA 303-724-1037 Terry.Batliner@ucdenver.edu
Contact: William G Henderson, MPH,PhD 303-724-1165 William.Henderson@ucdenver.edu

Sponsors and Collaborators

University of Colorado, Denver

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator:

Terry Batliner, DDS, MBA

University of Colorado, Denver

More Information

No publications provided

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01116726 History of Changes
Other Study ID Numbers:	08-0894, 09-004E, 1U54DE019259
Study First Received:	April 29, 2010
Last Updated:	November 21, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013