- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637309
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile (BR2S)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately one out of three 2- to 5-year-old children in the United States has experienced caries (tooth decay). The American Academy of Pediatric Dentistry and American Academy of Pediatrics provide recommendations for preventive strategies, and recognize that infant, toddler and early childhood oral health is one of the foundations upon which preventive education and dental care must be built to enhance the opportunity for a lifetime free from preventable oral disease. Parents struggle to adopt these preventive strategies at the same time that challenging behaviors emerge in children's psychological development. This combination can make it very difficult to build the foundation of oral health practices that the American Academy of Pediatric Dentistry and American Academy of Pediatrics recommends. There is a strong body of evidence supporting the use of behavioral parenting strategies in dealing with child behavioral problems. The proposed project introduces behavioral parent training strategies in concert with efforts to address other known parental barriers to provide an effective vehicle to promote dental health with a universal prevention intervention.
This private/public collaboration between Oregon Research Behavioral Intervention Strategies, Oregon Research Institute & The Oregon Community Foundation will leverage resources and competencies to create a commercially viable coordinated oral health prevention intervention program to promote dental health targeted at parents of young children attending parenting education classes and families receiving home visiting services through Head Start. The program includes a video that can be shown in parenting education classes to engage parents on oral health and a mobile/web application to drive behavioral change.
In this Phase I application, the investigators propose developing a coordinated oral health prevention intervention program, "BeReady2Smile", including video and mobile/web- application. An initial proof of concept version of this program and reminder set will be developed in the Phase I project and then tested for feasibility/usability among parents of young children. BeReady2Smile will include video content that features demonstrations/content on encouraging brushing, proper loading of toothbrush, brushing duration and frequency, fluoride myths, and limiting sugar sweetened beverages and milk in baby bottles while in bed. BeReady2Smile will also include a mobile application built within a web-based infrastructure, so parents can participate in multi-media educational activities, develop dental health behavior plans, tailor features and receive feedback from the system on a secure website. The long-term goal of BeReady2Smile is to help parents provide the foundation for a lifetime free from preventable oral disease.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults attending parent support groups with children 0-6 years.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BeReady2Smile Video and App
This arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program.
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BeReady2Smile is a coordinated oral health prevention intervention program that includes video content that features demonstrations/content on encouraging brushing, proper loading of toothbrush, brushing duration and frequency, fluoride myths, and limiting sugar sweetened beverages and milk in baby bottles while in bed.
BeReady2Smile will also include a mobile application built within a web-based infrastructure, so parents can participate in multi-media educational activities, develop dental health behavior plans, tailor features and receive feedback from the system on a secure website.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with BeReady2Smile
Time Frame: Up to 16 weeks
|
Satisfaction was assessed by participants' ratings on a 1-4 scale (from "Liked very much" to "Not at all liked") of the question "How much did you like BeReady2Smile for learning the information taught?"
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Up to 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attitudes toward Dental Behaviors: Importance and Intention to Brush Child's Teeth
Time Frame: Baseline, up to 16 weeks
|
Parental attitudes toward dental behaviors were assessed by four scales included in the questionnaires developed by Adair and colleagues (2004) including the 'Importance and Intention to Brush Child's Teeth' (five items).
Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
|
Baseline, up to 16 weeks
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Attitudes toward Dental Behaviors: Parental Efficacy in Relation to Child Toothbrushing
Time Frame: Baseline, up to 16 weeks
|
Parental attitudes toward dental behaviors were assessed by four scales included in the questionnaires developed by Adair and colleagues (2004) that included Parental Efficacy in Relation to Child Toothbrushing' (six items).
Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
|
Baseline, up to 16 weeks
|
Attitudes toward Dental Behaviors: Perceived Seriousness of Tooth Decay in Children
Time Frame: Baseline, up to 16 weeks
|
Parental attitudes toward dental behaviors were assessed by four scales included in the questionnaires developed by Adair and colleagues (2004) that included Perceived Seriousness of Tooth Decay in Children' (seven items).
Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
|
Baseline, up to 16 weeks
|
Attitudes toward Dental Behaviors: Chance Control - Decay Occurs by Chance
Time Frame: Baseline, up to 16 weeks
|
Parental attitudes toward dental behaviors were assessed by four scales included in the questionnaires developed by Adair and colleagues (2004) that includes 'Chance Control - Decay Occurs by Chance' (five items).
Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
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Baseline, up to 16 weeks
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Application Usage
Time Frame: up to 16 weeks
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Activity logs tracked the use of the BeReady2Smile website with a time and date for every online activity.
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up to 16 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: David R Smith, PhD, Orbis
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DE027001-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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