Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries

February 28, 2020 updated by: University of Minnesota
The study's aim was to investigate if a motivational interviewing intervention (MI) improved oral self-care behaviors of AIAN caregivers of infants and determine if the MI intervention promoted positive changes in caregivers' ECC risk-related behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- healthy mothers/caregivers of infants

Exclusion Criteria:

  • Subjects with recent antibiotic use (within 3 months)
  • Subjects on any medication that is immunosuppressive
  • Subjects who self-report they have xerostomia due to medication use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
The treatment group received motivational interviewing.
Behavioral: Motivational Interviewing
Participants/caregivers will receive several telephone-based and in-person motivational interviewing sessions along with specific oral health recommendations.
No Intervention: Control Group
The control group received standard information only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Concentration of Lactobacilli
Time Frame: Baseline, 8 months
Oral concentration of Lactobacilli will be measured using a Caries Risk Test (CRT). Outcome will be reported in colony-forming units per milliliter (CFU/mL).
Baseline, 8 months
Change in Concentration of Mutans Streptococcus
Time Frame: Baseline, 8 months
Oral concentration of Mutans streptococcus will be measured using a Caries Risk Test (CRT). Outcome will be reported in colony-forming units per milliliter (CFU/mL).
Baseline, 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Christine Blue, BSDH, MS, DHSc, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1107M02642

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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