Clinical trial NCT03637309: Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
Official title: Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Satisfaction with BeReady2Smile
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Attitudes toward Dental Behaviors: Importance and Intention to Brush Child's Teeth
timeFrame: Baseline, up to 16 weeks
measure: Attitudes toward Dental Behaviors: Parental Efficacy in Relation to Child Toothbrushing
timeFrame: Baseline, up to 16 weeks
measure: Attitudes toward Dental Behaviors: Perceived Seriousness of Tooth Decay in Children
timeFrame: Baseline, up to 16 weeks
measure: Attitudes toward Dental Behaviors: Chance Control - Decay Occurs by Chance
timeFrame: Baseline, up to 16 weeks
measure: Application Usage
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Orbis
name: David R Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: