ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01116726
Recruitment Status : Active, not recruiting
First Posted : May 5, 2010
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Colorado, Denver

April 29, 2010
May 5, 2010
October 16, 2018
August 2011
December 2018   (Final data collection date for primary outcome measure)
Decayed,missing, and filled tooth surfaces (dmfs) [ Time Frame: Over 3 years ]
Same as current
Complete list of historical versions of study NCT01116726 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Over 3 years ]
    ds, % of children with dmfs and ds >0
  • 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 ]
Not Provided
Not Provided
 
Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Early Childhood Dental Caries
  • 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.
  • 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.
    Interventions:
    • Behavioral: Motivational interviewing
    • Behavioral: Enhanced community services
  • 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.
    Intervention: Behavioral: Enhanced community services

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1134
600
February 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
15 Years to 44 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01116726
08-0894
09-004E ( Other Grant/Funding Number: National Institute of Dental and Craniofacial Research )
1U54DE019259 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Terry Batliner, DDS, MBA University of Colorado, Denver
University of Colorado, Denver
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP