Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
Primary Purpose
Caries,Dental
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LHA intervention
brochure-only
Sponsored by
About this trial
This is an interventional prevention trial for Caries,Dental focused on measuring Caries, immigrant, Lay health advisor, preventive behavior, oral hygiene
Eligibility Criteria
Inclusion Criteria:
- Vietnamese women whose children aged 2-6 years
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group (IG)
Control group (CG)
Arm Description
LHA intervention group (IG)
brochure-only control group (CG)
Outcomes
Primary Outcome Measures
dmft index
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
dmft index
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
dmft index
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Secondary Outcome Measures
Maternal preventive behavior
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Maternal preventive behavior
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Maternal caries-related knowledge
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Maternal caries-related knowledge
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Maternal attitude toward oral hygiene
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Maternal attitude toward oral hygiene
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Maternal self-efficacy toward oral hygiene
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Maternal self-efficacy toward oral hygiene
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Full Information
NCT ID
NCT04562675
First Posted
September 14, 2020
Last Updated
September 23, 2020
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04562675
Brief Title
Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
Official Title
Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2012 (Actual)
Primary Completion Date
October 31, 2015 (Actual)
Study Completion Date
October 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the long-term effectiveness of a lay health advisor (LHA) intervention on immigrant children's caries and preventive behaviors.This randomized controlled trial included mother-child pairs in the intervention group (IG) and a brochure-only control group (CG), respectively. The IG received a four-week one-on-one session by an LHA on caries-related knowledge and brushing techniques. Baseline and follow-up surveys were used to collect the data in caries experience and maternal caries preventive behavior.
Detailed Description
A randomized experimental design was used. Vietnamese women whose children aged 2-6 years were recruited through churches, Chinese schools, immigrant service centers, kindergarten, or recommendations from LHAs in Kaohsiung City in Taiwan. Overall, 30 and 25 Vietnamese mother-child pairs were randomized into the IG and CG. G*Power (version 3.1.9.4) was used for power analysis. A power analysis was established by effect size as the mean difference of filled teeth change between baseline and 8-month follow-up measurement between the IG and CG, with sample size and 0.05 alpha level. The power was greater than 0.802, and research results have adequate power.All children underwent oral examination at baseline and at 1-week, 2- and 8-month follow-ups. Each child was examined by a dentist in accordance with the primary dentition caries experience.Each immigrant mother completed surveys at baseline and at 1-week and 8-month follow-ups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental
Keywords
Caries, immigrant, Lay health advisor, preventive behavior, oral hygiene
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Description
LHA intervention group (IG)
Arm Title
Control group (CG)
Arm Type
Placebo Comparator
Arm Description
brochure-only control group (CG)
Intervention Type
Behavioral
Intervention Name(s)
LHA intervention
Intervention Description
For the IG, a 4-hour lesson consisting of 4 chapters and leaflets was delivered over 4 weeks, with one chapter per hour per week. Each LHA visited the assigned mother in the IG four times in a 4-week period.
Intervention Type
Other
Intervention Name(s)
brochure-only
Intervention Description
brochure-only for control group (CG)
Primary Outcome Measure Information:
Title
dmft index
Description
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Time Frame
Change from Baseline dmft at 1 weeks after intervention
Title
dmft index
Description
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Time Frame
Change from Baseline dmft at 2 months after intervention
Title
dmft index
Description
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Time Frame
Change from Baseline dmft at 8 months after intervention
Secondary Outcome Measure Information:
Title
Maternal preventive behavior
Description
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Time Frame
Change from Baseline at 1 weeks after intervention
Title
Maternal preventive behavior
Description
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Time Frame
Change from Baseline at 8 months after intervention
Title
Maternal caries-related knowledge
Description
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Time Frame
Change from Baseline at 1 weeks after intervention
Title
Maternal caries-related knowledge
Description
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Time Frame
Change from Baseline at 8 months after intervention
Title
Maternal attitude toward oral hygiene
Description
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Time Frame
Change from Baseline at 1 weeks after intervention
Title
Maternal attitude toward oral hygiene
Description
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Time Frame
Change from Baseline at 8 months after intervention
Title
Maternal self-efficacy toward oral hygiene
Description
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Time Frame
Change from Baseline at 1 weeks after intervention
Title
Maternal self-efficacy toward oral hygiene
Description
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Time Frame
Change from Baseline at 8 months after intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Vietnamese women whose children aged 2-6 years
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Ling Huang
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
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