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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Early Childhood Dental Caries

Intervention / Treatment
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* Behavioral: Motivational interviewing
* Behavioral: Enhanced community services


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational interviewing and enhanced community services<br>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<br>* 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.<br>Behavioral: Enhanced community services<br>* 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.<br>|
| Active Comparator: Enhanced community services<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |