Testing a Tooth Decay Prevention Program With Cree Mothers and Infants

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175318
First received: September 9, 2005
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

Dental decay is an alarming problem in Cree children. The intervention is a behavioural counseling approach called Motivational Interviewing (MI). The dental health of young children in communities whose mothers had a series of MI sessions provided by Cree women will be compared to the dental health of mothers who did not have the intervention.


Condition Intervention
Dental Caries
Behavioral: Motivational Interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Trial of the Effectiveness of Motivational Interviewing as a Preventive Strategy for Dental Caries in Cree Infants

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Dental health status of children 30 months of age in test and control communities [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mothers' beliefs about child dental health, children's dental health practices, and the negative health outcomes of dental caries assessed at project's end. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 309
Study Start Date: April 2005
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Motivational Interviewing
    Beginning at 12 months of age, regular application of fluoride varnish will be an option that a mother in the MI group may choose for her child. Control families will receive dental health information from a pamphlet, and will have access to fluoride varnish at local dental clinics.
Detailed Description:

Dental decay is an alarming problem in Cree children. The intervention is a behavioural counseling approach called Motivational Interviewing (MI). The dental health of young children in communities whose mothers had a series of MI sessions provided by Cree women will be compared to the dental health of mothers who did not have the intervention.

The proposed randomized controlled trial, involving Cree mothers and children in Eeyou Istchee, will test the effectiveness of an innovative, one-on-one counseling program called Motivational Interviewing (MI). In keeping with Cree philosophy and traditions, MI allows mothers to choose from a "menu" of preventive dental behaviours. The primary research question is whether there will be any difference in the dental health status of Cree children from communities where mothers have participated in MI interventions, compared to children from communities where mothers received information by more traditional means (pamphlets). This question will be answered by testing the hypothesis that the prevalence of caries among children 30 months of age will be lower in experimental "MI" communities than in control communities. The secondary questions are whether Cree mothers' beliefs about child dental health, children's dental health practices, and the negative health outcomes of ECC will be altered in MI communities compared to control communities.

Trial design: Over the past two years, the project team has undertaken extensive community consultation to better understand the problem of dental caries in young Cree children, and to seek community input for the project. The design is single blind, with cluster randomization by community, and two treatment groups. A total study sample of 309 mother-child pairs accounts for attrition of 15% over 3 years, and for infant mortality. The power is 82% to detect a 20% reduction in caries prevalence. The "experimental" treatment, MI, will assist mothers to choose from a menu of various age-appropriate, preventive options. The first intervention will occur during pregnancy, followed by regular MI sessions beginning at the child's 2-month immunization until 24 months of age. Local Cree dental assistants, following training and calibration in the MI technique, will do the counseling. Beginning at 12 months of age, regular application of fluoride varnish will be an option that a mother in the MI group may choose for her child. Control families will receive dental health information from a pamphlet, and will have access to fluoride varnish at local dental clinics.

Outcomes assessment: To answer the first research question, calibrated dentists from outside of Eeyou Istchee will do dental examinations for children at 30+3 months of age. Mothers will complete questionnaires to answer the secondary questions. The primary statistical analysis will be a comparison of caries prevalence in intervention and control groups, using a permutation test with test statistic equal to the difference between caries prevalences in the two groups. A significance level will be determined using the exact permutation distribution of the test statistic, which will be computed by enumerating all possible random assignments of villages to intervention or control conditions according to the randomization scheme..

  Eligibility

Ages Eligible for Study:   14 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

First Nations women from the 9 communities of Eeyou Istchee (Cree territory of James Bay, Quebec) who are pregnant or have a pre-dentate infant l

Exclusion Criteria:

  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: NCT00175318

Locations
Canada, Quebec
Cree Board of Health and Social Services of James Bay
Chisasibi, Quebec, Canada, JOM-1EO
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Rosamund Harrison, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Rosamund Harrison, Univerisity of British Columbia
ClinicalTrials.gov Identifier: NCT00175318     History of Changes
Other Study ID Numbers: B04-0295, PG14R90995
Study First Received: September 9, 2005
Last Updated: February 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Motivational interviewing
behavioural modification
maternal counseling

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

ClinicalTrials.gov processed this record on October 30, 2014