Testing a Tooth Decay Prevention Program With Cree Mothers and Infants
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      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.
    

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..
    

Intervention name(s): Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Motivational interviewing; behavioural modification; maternal counseling