NCT04286256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 24, 2020

Last Update Submit

February 28, 2020

Conditions

Keywords

Early Childhood CariesMotivational Interviewing

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline, 8 months

  • 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).

    Baseline, 8 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group received motivational interviewing.

Behavioral: Motivational Interviewing

Control Group

NO INTERVENTION

The control group received standard information only.

Interventions

Participants/caregivers will receive several telephone-based and in-person motivational interviewing sessions along with specific oral health recommendations.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- healthy mothers/caregivers of infants

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dental Caries

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christine Blue, BSDH, MS, DHSc

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

October 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations