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

Primary Purpose

Early Childhood Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing
Enhanced community services
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Early Childhood Dental Caries

Eligibility Criteria

15 Years - 44 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational interviewing and enhanced community services

Enhanced community services

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Decayed,missing, and filled tooth surfaces (dmfs)

Secondary Outcome Measures

Dental knowledge, attitudes, and behaviors of the mothers
Dental caries patterns of the children
Costs of dental care
Other decayed, missing, and filled tooth surfaces measures
ds, % of children with dmfs and ds >0

Full Information

First Posted
April 29, 2010
Last Updated
July 6, 2021
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT01116726
Brief Title
Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
Official Title
Promoting Behavioral Change for Oral Health in American Indian Mothers and Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Dental Caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing and enhanced community services
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced community services
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced community services
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decayed,missing, and filled tooth surfaces (dmfs)
Time Frame
Over 3 years
Secondary Outcome Measure Information:
Title
Dental knowledge, attitudes, and behaviors of the mothers
Time Frame
Over 3 years
Title
Dental caries patterns of the children
Time Frame
Over 3 years
Title
Costs of dental care
Time Frame
Up to 3 years after randomization
Title
Other decayed, missing, and filled tooth surfaces measures
Description
ds, % of children with dmfs and ds >0
Time Frame
Over 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Batliner, DDS, MBA
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24735707
Citation
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.
Results Reference
background
PubMed Identifier
30238061
Citation
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.
Results Reference
derived
PubMed Identifier
28526003
Citation
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.
Results Reference
derived

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

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