Dental CariesNCT00175318
Testing a Tooth Decay Prevention Program With Cree Mothers and Infants
A study testing Motivational Interviewing in people with Dental Caries, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 309 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cree Board of Health and Social Services of James Bay
Chisasibi, Quebec, JOM-1EO
About this study
Official title: A Clinical Trial of the Effectiveness of Motivational Interviewing as a Preventive Strategy for Dental Caries in Cree Infants
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.
Read the 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..
- Conditions
- Dental Caries
- Being tested
- Motivational Interviewing
- Keywords
- Motivational interviewing, behavioural modification, maternal counseling
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental health status of children 30 months of age in test and control communities
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Rosamund Harrison, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175318
- Sponsor's protocol ID
- B04-0295
- Other IDs
- PG14R90995
- Status last verified
- Feb 2011
- First submitted
- 9 Sep 2005
- Last updated
- 11 Feb 2011
- Results posted
- No
Publications
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.
PubMed 20465831
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Effectiveness of Motivational Interviewing as a Preventive Strategy for Dental Caries in Cree Infants
- ClinicalTrials.gov ID
- NCT00175318
- Acronym / sponsor ID
- B04-0295
- Conditions
- Dental Caries
- Keywords
- Motivational interviewing, behavioural modification, maternal counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingBeginning 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. | Behavioural | – |
Primary outcome
Dental health status of children 30 months of age in test and control communities
Time frame: 24 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2011.
- Results publication: PubMed 20465831Harrison 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosamund Harrison, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Dental Caries, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental health status of children 30 months of age in test and control communities (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00175318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2011.