Clinical trial NCT01116726: 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
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Dental Caries
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-05-05
Enrollment: 1134
Sex: ALL
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Decayed,missing, and filled tooth surfaces (dmfs)
timeFrame: Over 3 years
Secondary outcomes:
measure: Dental knowledge, attitudes, and behaviors of the mothers
timeFrame: Over 3 years
measure: Dental caries patterns of the children
timeFrame: Over 3 years
measure: Costs of dental care
timeFrame: Up to 3 years after randomization
measure: Other decayed, missing, and filled tooth surfaces measures
timeFrame: Over 3 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Terry Batliner, DDS, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.