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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Dental Caries
• Intervention / Treatment: Behavioral: Motivational interviewing; Behavioral: Enhanced community services

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 children's ds, % with dmfs and ds >0, mother's dental knowledge, attitudes, and behaviors, caries patterns, and costs.

• Study Type: Interventional
• Enrollment (Actual): 1134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decayed,missing, and filled tooth surfaces (dmfs)	Over 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental knowledge, attitudes, and behaviors of the mothers		Over 3 years
Dental caries patterns of the children		Over 3 years
Costs of dental care		Up to 3 years after randomization
Other decayed, missing, and filled tooth surfaces measures	ds, % of children with dmfs and ds >0	Over 3 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Terry Batliner, DDS, MBA, University of Colorado, Denver

Publications and helpful links

General Publications

• Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.
• 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.
• Batliner TS, Tiwari T, Henderson WG, Wilson AR, Gregorich SE, Fehringer KA, Brega AG, Swyers E, Zacher T, Harper MM, Plunkett K, Santo W, Cheng NF, Shain S, Rasmussen M, Manson SM, Albino J. Randomized Trial of Motivational Interviewing to Prevent Early Childhood Caries in American Indian Children. JDR Clin Trans Res. 2018 Oct;3(4):366-375. doi: 10.1177/2380084418787785. Epub 2018 Jul 12.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 5, 2010

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 08-0894; 1U54DE019259 (U.S. NIH Grant/Contract); 09-004E (Other Grant/Funding Number: National Institute of Dental and Craniofacial Research)