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

NCT01116726 | Completed DMC

• 3 other identifiers: 08-089409-004E1U54DE019259
• Study Type: interventional
• Target: 1,134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Childhood Dental Caries

Outcome Measures

Primary Outcomes (1)

• Decayed,missing, and filled tooth surfaces (dmfs)

  Over 3 years

Secondary Outcomes (4)

• 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

  Over 3 years

Study Arms (2)

Motivational interviewing and enhanced community services

EXPERIMENTAL

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; Behavioral: Enhanced community services

Enhanced community services

ACTIVE COMPARATOR

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

Interventions

Motivational interviewing BEHAVIORAL

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.

Motivational interviewing and enhanced community services

Enhanced community services BEHAVIORAL

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.

Enhanced community services; Motivational interviewing and enhanced community services

Eligibility Criteria

• Age: 15 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• 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.

  PMID: 24735707 BACKGROUND

• 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.

  PMID: 30238061 DERIVED

• 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.

  PMID: 28526003 DERIVED

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Terry Batliner, DDS, MBA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 5, 2010
• Study Start: August 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

US (1)