Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile (BR2S)

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults attending parent support groups with children 0-6 years.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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?"
Up to 16 weeks

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
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).
Baseline, up to 16 weeks
Application Usage
Time Frame: up to 16 weeks
Activity logs tracked the use of the BeReady2Smile website with a time and date for every online activity.
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David R Smith, PhD, Orbis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2017

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

July 19, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DE027001-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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