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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01116726
First received: April 29, 2010
Last updated: August 15, 2014
Last verified: August 2014
  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:


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 2017
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Terry Batliner, DDS, MBA University of Colorado, Denver
  More Information

Publications:
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: August 15, 2014
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 August 19, 2014