Back to resultsUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
Primary Purpose
Caries,Dental, Caries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
About this trial
This is an interventional treatment trial for Caries,Dental focused on measuring Early Childhood Caries, Motivational Interviewing
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment Group
Control Group
Arm Description
The treatment group received motivational interviewing.
The control group received standard information only.
Outcomes
Primary Outcome Measures
Change in Concentration of Lactobacilli
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).
Change in Concentration of Mutans Streptococcus
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04286256
First Posted
February 24, 2020
Last Updated
February 28, 2020
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04286256
Brief Title
Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
Official Title
Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
November 1, 2012 (Actual)
Study Completion Date
November 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental, Caries
Keywords
Early Childhood Caries, Motivational Interviewing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
The treatment group received motivational interviewing.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received standard information only.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Participants/caregivers will receive several telephone-based and in-person motivational interviewing sessions along with specific oral health recommendations.
Primary Outcome Measure Information:
Title
Change in Concentration of Lactobacilli
Description
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).
Time Frame
Baseline, 8 months
Title
Change in Concentration of Mutans Streptococcus
Description
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).
Time Frame
Baseline, 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Blue, BSDH, MS, DHSc
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32223762
Citation
Blue CM, Arnett MC, Ephrem H, Lunos S, Ruoqiong C, Jones R. Using motivational interviewing to reduce parental risk related behaviors for early childhood caries: a pilot study. BMC Oral Health. 2020 Mar 29;20(1):90. doi: 10.1186/s12903-020-1052-6.
Results Reference
derived
Learn more about this trial
Using Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood Caries
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