NCT05321719

Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile II

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Oregon Research Behavioral Intervention Strategies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"BeReady2Smile (BR2S)", based on successful results from the Phase I SBIR feasibility/usability research of the prototype, is a coordinated oral health prevention intervention program that provides empirically-supported behavioral parent training (BPT) skills and oral health instruction through the use of video and mobile/web- application. In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. The investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to our usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior. The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.

Detailed description

Primary Objective: Assess the efficacy of the BR2S intervention program in the context of established parenting education systems (e.g., Head Start and Oregon Parenting Education Collaborative). A sub-sample of participants will complete an observational interaction procedure as measured by The Dyadic Parent-Child Interactive Coding System. Secondary Objectives: 1. Assess relative contribution of BR2S components to outcomes to provide insight on options for dissemination using Usual Care Video only (UC control) or BeReady2Smile Video only or BeReady2Smile video + app or BeReady2Smile Video + app + coach. 2. Assess aspects of user experience with the BR2S program Primary Endpoint: This study will provide outcomes for a primary endpoints that will compare BeReady2Smile to comparison (usual care video) as measured by the Plaque Control Record. The Plaque Control Record is a very simple percentage or score of the total amount of bacteria present in the mouth. A tooth has 4 surfaces at the gum line being; the cheek side, tongue side, front side, and back side. A hygienist will disclose or stain up the Bacterial Plaque to show where one may be missing. Secondary Endpoints: 1. With this study's data, additional secondary endpoints the investigators will investigate the effects of BeReady2Smile video alone and BeReady2Smile video + app compared to the usual-care video as well as the impact of a coach (Oral Health Educator). The investigators will also measure behavioral change, self-efficacy, establishment of dental home knowledge, and attitudes. 2. User experience will be measured by Coach Feedback, App feedback, and Video satisfaction. Study Population: Caregivers, who have a child 0-6 years, enrolled in a participating social service agency providing parenting education, such as Head Start; and are able to communicate in English or Spanish. Phase\* or Stage: 2 Description of Sites/Facilities Enrolling Participants: The study is being conducted at ORBIS, where the investigators, and bachelor- and masters-level recruitment staff, computer programmers, data management staff, and data analyst are housed. Enrollment of eligible parents, technological adaptations for the intervention, data analysis, and manuscript production will be completed there. Agency staff at Head Start and Oregon Parenting Education Collaborative will inform parents about the project and will get parent permission to share their contact information with the family recruiters at ORBIS. Description of Study Intervention/Experimental Manipulation: BR2S is a 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. Participants will be randomized in one of 4 experimental conditions (Usual care video; BR2S video; BR2S video + app; BR2Svideo + app + coach) with the primary comparison being between those who were exposed to one or more component of BR2S and those who received a usual care video.

Conditions

• Plaque

Interventions

Type	Name	Description
BEHAVIORAL	Comparison Condition	In this Phase II project, BR2S will be evaluated for efficacy relative to a usual care control. Investigators expect BR2S to improve outcomes on behavioral change, self-efficacy, establishment of a dental home, knowledge, and attitudes in real settings relative to the usual care condition. The outcome measures include a direct clinical dental measure as well as observational measures of parental behavior. The study will also provide important information regarding the various types and combinations of BeReady2Smile product components for dissemination. The long-term goal of the program is to help parents provide the foundation for a lifetime free from preventable oral disease.
BEHAVIORAL	BeReady2Smile video only	The video will be viewed at the Head Start site after informed consent and T1 questionnaires and plaque assessment. The video will include concrete demonstrations and feature diversity in settings and actors in video content derived from actual peer-based parenting education sessions. Parents' ability to "see themselves" in the content makes them more likely to engage in discussions about dental health. Supporting these conversations has been identified as an important need. For example, in a recent environmental scan prepared by the Association of State and Territorial Dental Directors the lack of communication strategies was identified as a gap in oral health educational resources. Specifically mentioned was the lack of oral health curricula that support interactive communication between families and home visitors. Families struggle with such dialogues.
BEHAVIORAL	BeReady2Smile video and BeReady2Smile app completely self-guided	In addition to the BeReady2Smile video as described above, the BeReady2Smile app includes: (a) presentation of concepts, behaviors, and examples via video and text, (b) electronically presented check-in questions recorded to a database for review, (c) capture of a 5-minute video of parent-child interactions uploaded for later review by the parent, using a mobile application, (d) daily dental activities (homework), and (e) program feedback recorded to the database. BeReady2Smile will be designed such that before the parent can go on to a new area of learning, the parent must complete the previous lesson. Participants can go back and review previous material in a non-linear format. The database and log-files record all computer activities to track use of each intervention component.
BEHAVIORAL	"Complete" BeReady2Smile video and BeReady2Smile app guided by a Coach	In addition to the BeReady2Smile video and BeReady2Smile app described above, the "complete" intervention includes support via phone and text from a trained facilitator/coach who builds supportive one-on-one relationships with the parent and gives feedback on parent-recorded videos of parent-child interactions of tooth-brushing, designed to facilitate learning and promote engagement with their oral health professional; and tools to create a long-term follow-up plan. Dental behaviors will be tailored for children's developmental level (e.g. twice daily tooth brushing for preschoolers and limiting sugar sweetened beverages or milk in bottles at bed for infants).

Timeline

• Start date: 2023-04-10
• Primary completion: 2024-04-24
• Completion: 2024-04-30
• First posted: 2022-04-11
• Last updated: 2025-10-08

Locations

1 site across 1 country: United States