NCT00175318

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
309

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

Enrollment Period

5.8 years

First QC Date

September 9, 2005

Last Update Submit

February 9, 2011

Conditions

Dental Caries

Keywords

Motivational interviewingbehavioural modificationmaternal counseling

Outcome Measures

Primary Outcomes (1)

  • Dental health status of children 30 months of age in test and control communities

    24 months

Secondary Outcomes (1)

  • Mothers' beliefs about child dental health, children's dental health practices, and the negative health outcomes of dental caries assessed at project's end.

    24 months

Interventions

Motivational InterviewingBEHAVIORAL

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.

Eligibility Criteria

Age14 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cree Board of Health and Social Services of James Bay

Chisasibi, Quebec, JOM-1EO, Canada

Location

Related Publications (1)

  • Harrison R, Veronneau J, Leroux B. Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities. Trials. 2010 May 13;11:54. doi: 10.1186/1745-6215-11-54.

    PMID: 20465831RESULT

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

  • Rosamund Harrison, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

April 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

CA(1)