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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03637309
Other study ID # DE027001-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2017
Est. completion date August 31, 2018

Study information

Verified date November 2021
Source Oregon Research Behavioral Intervention Strategies, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults attending parent support groups with children 0-6 years. Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BeReady2Smile Video and App
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.

Locations

Country Name City State
United States Oregon Research Institute Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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?" Up to 16 weeks
Secondary 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). Baseline, up to 16 weeks
Secondary 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). Baseline, up to 16 weeks
Secondary 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). Baseline, up to 16 weeks
Secondary 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). Baseline, up to 16 weeks
Secondary Application Usage Activity logs tracked the use of the BeReady2Smile website with a time and date for every online activity. up to 16 weeks
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