Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175318
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2005-09-09
Brief Title:
Testing a Tooth Decay Prevention Program With Cree Mothers and Infants
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Clinical Trial of the Effectiveness of Motivational Interviewing as a Preventive Strategy for Dental Caries in Cree Infants
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childrens 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 childs 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 303 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
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 childrens 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 childs 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 303 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PG14R90995 | None | None | None |