Evaluation of a Brief Tailored Motivational Intervention to Prevent Early Childhood Caries

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01123330
First received: May 12, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

The Detroit Dental Health Project (DDHP)aims to promote oral health and reduce disparities within the community of low-income African-American children (0-5 years) and their main caregivers (14+ years), living in the City of Detroit. The driving theme of the Project is to identify determinants and design interventions to answer the following question: why do some low-income African-American children and their main caregivers have better oral health than others who live in the same community? The Project has 3 support cores, 4 research core projects and 1 pilot study. The Project has selected a multistage random sample of African-American families living in the poorest 39 Census Tracts in the City of Detroit. A total of 1,022 families were recruited and interviewed at a community center in Detroit during the year 2 (2002). We have collected data about the social characteristics of parents, families, and neighborhoods that are associated with disparities in oral health; lead levels in saliva and blood of the caregivers; and dietary intake. All these families will be recalled in the year 4 (2004) and year 6 (2006) for longitudinal data collection. We are currently developing a tailored multi-media educational intervention (Project #3), based on data collected in the first phase (2002). The educational intervention will be administered using a randomized controlled design in year 4 (2004). Additionally, the Project is evaluating the impact on access to dental care of a state-funded experiment on utilization where Medicaid children are managed like privately insured patients (Project #4).


Condition Intervention Phase
Dental Caries
Behavioral: Motivational Interviewing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Detroit Research Center on Oral Health Disparities

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Carious lesions [ Time Frame: Measures at baseline (2002-03); wave 2 (2004-05); wave 3 (2007) ] [ Designated as safety issue: No ]
    The carious process was measured using the International Caries Detection and Assessment System (ICDAS). The codes range from measurement of the first visible carious change in enamel (Code 1) to extensive cavitation (Code 6). Both primary carious lesions and lesions adjacent to restorations and sealants (CARS) were recorded,.


Enrollment: 2042
Study Start Date: October 2001
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivational Interviewing plus DVD
Caregivers watched a 15-minute educational video designed for the project emphasizing the importance of good oral health in children, and how the caregiver can keep children free from tooth decay. The MI interviewer engaged the parent in a discussion of their thoughts and concerns regarding their child's oral health and what changes they wished to make regarding monitoring their child's oral health. Feedback from the child's dental exam was also reviewed. MI+DVD caregivers received a brochure displaying a photo of their child and for those who chose to set specific goals for their child's oral health, those goals were listed on the brochure. Caregivers choosing not to set specific goals were offered a list of 10 project recommendations regarding dietary intake, oral hygiene, and dental check-ups. The session ended with a dialogue regarding possible barriers to implementing the personal plan and how the caregiver planned to overcome those barriers.
Behavioral: Motivational Interviewing
Active Comparator: DVD only
Caregivers watched the same educational video. At the end of the video, caregivers were given a glossy-printed brochure displaying the project developed recommendations as well as the child's photograph. The brochure was not re-mailed, as it was for the MI+DVD group and caregivers in this condition did not receive any feedback from the dental examination regarding their child's oral health status.
Behavioral: Motivational Interviewing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African-American
  • 0-5 years of age
  • below 250% of poverty

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123330

Locations
United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Temple University
University of Michigan
  More Information

Publications:

Responsible Party: Amid I. Ismail, Temple University
ClinicalTrials.gov Identifier: NCT01123330     History of Changes
Other Study ID Numbers: U54DE1426101
Study First Received: May 12, 2010
Last Updated: May 12, 2010
Health Authority: United States: National Institutes of Health

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 23, 2014