Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile (BR2S)
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BeReady2Smile Video and App
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries in Children
Eligibility Criteria
Inclusion Criteria:
- Adults attending parent support groups with children 0-6 years.
Exclusion Criteria:
- none
Sites / Locations
- Oregon Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BeReady2Smile Video and App
Arm Description
This arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program.
Outcomes
Primary Outcome Measures
Satisfaction with BeReady2Smile
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?"
Secondary Outcome Measures
Attitudes toward Dental Behaviors: Importance and Intention to Brush Child's Teeth
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).
Attitudes toward Dental Behaviors: Parental Efficacy in Relation to Child Toothbrushing
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).
Attitudes toward Dental Behaviors: Perceived Seriousness of Tooth Decay in Children
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).
Attitudes toward Dental Behaviors: Chance Control - Decay Occurs by Chance
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).
Application Usage
Activity logs tracked the use of the BeReady2Smile website with a time and date for every online activity.
Full Information
NCT ID
NCT03637309
First Posted
July 19, 2018
Last Updated
November 23, 2021
Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03637309
Brief Title
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
Acronym
BR2S
Official Title
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Behavioral Intervention Strategies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This application, BeReady2Smile, will promote dental health behavioral parenting strategies among parents by incorporating a behavioral program for their children. Parents use a multimedia 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. Once developed, BeReady2Smile will be field tested for usability and usefulness with a group of parents of young children. Parents will rate the level of support needed, confidence in the system, and ease of use at each stage in the development, initiation, and maintenance of the system.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BeReady2Smile Video and App
Arm Type
Experimental
Arm Description
This arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program.
Intervention Type
Behavioral
Intervention Name(s)
BeReady2Smile Video and App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction with BeReady2Smile
Description
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?"
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Attitudes toward Dental Behaviors: Importance and Intention to Brush Child's Teeth
Description
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).
Time Frame
Baseline, up to 16 weeks
Title
Attitudes toward Dental Behaviors: Parental Efficacy in Relation to Child Toothbrushing
Description
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).
Time Frame
Baseline, up to 16 weeks
Title
Attitudes toward Dental Behaviors: Perceived Seriousness of Tooth Decay in Children
Description
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).
Time Frame
Baseline, up to 16 weeks
Title
Attitudes toward Dental Behaviors: Chance Control - Decay Occurs by Chance
Description
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).
Time Frame
Baseline, up to 16 weeks
Title
Application Usage
Description
Activity logs tracked the use of the BeReady2Smile website with a time and date for every online activity.
Time Frame
up to 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults attending parent support groups with children 0-6 years.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Smith, PhD
Organizational Affiliation
Orbis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://beready2smile.ori.org
Description
Intervention Website
Learn more about this trial
Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
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