Testing a Tooth Decay Prevention Program With Cree Mothers and Infants
This study is currently recruiting patients
Verified by University of British Columbia September 2005
||University of British Columbia
|Information provided by:
||University of British Columbia
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.
||Behavior: Motivational Interviewing
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: A Clinical Trial of the Effectiveness of Motivational Interviewing as a Preventive Strategy for Dental Caries in Cree Infants
Further study details as provided by University of British Columbia:
Primary Outcomes: Dental health status of children 30 months of age in test and control communities
Secondary Outcomes: Mothers’ beliefs about child dental health, children’s dental health practices, and the negative health outcomes of dental
caries assessed at project’s end.
Expected Total Enrollment:
Study start: April 2005;
Expected completion: March 2010
Last follow-up: September 2009;
Data entry closure: January 2010
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..
Ages Eligible for Study:
Genders Eligible for Study:
Accepts Healthy Volunteers
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
Please refer to this study by ClinicalTrials.gov identifier
Cree Board of Health and Social Services of James Bay, Chisasibi,
Study chairs or principal investigators
Rosamund Harrison, PhD, Principal Investigator, University of British Columbia
Study ID Numbers:
September 9, 2005
Record first received:
September 9, 2005
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2006-09-29