Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile II
NCT05321719 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228
Last updated 2025-10-08
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.
Conditions
- Plaque
Interventions
- 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).
Sponsors & Collaborators
-
National Institute of Dental and Craniofacial Research (NIDCR)
collaborator NIH -
Oregon Research Behavioral Intervention Strategies, Inc.
lead INDUSTRY
Principal Investigators
-
David R Smith, PhD · Oregon Research Behavioral Intervention Strategies, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-10
- Primary Completion
- 2024-04-24
- Completion
- 2024-04-30
Countries
- United States
Study Locations
More Related Trials
-
Childhood Obesity Treatment Targeting Specific Behaviors
NCT00259324 ·Status: COMPLETED ·Phase: NA
-
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2
NCT02751814 ·Status: COMPLETED
-
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
NCT01146314 ·Status: COMPLETED ·Phase: NA
-
Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity
NCT01419951 ·Status: COMPLETED ·Phase: PHASE1
-
Dissemination and Implementation of the Bright Bodies Intervention for Childhood Obesity
NCT05595161 ·Status: COMPLETED ·Phase: NA
-
Pediatric Healthy Weight Clinic
NCT05020314 ·Status: COMPLETED ·Phase: NA
-
Family-based Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity
NCT02060279 ·Status: COMPLETED ·Phase: NA
-
Acceptance-based Care for Child Eating and Physical Activity Treatment
NCT03368716 ·Status: COMPLETED ·Phase: NA
-
Intervention INC: An Interactive Family-centered mHealth Tool to Reduce Obesity Risk in Urban Minority Preadolescents
NCT05935592 ·Status: RECRUITING ·Phase: NA
-
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 1
NCT02751788 ·Status: COMPLETED
-
Preschool Based Obesity Prevention Effectiveness Trial
NCT00241878 ·Status: COMPLETED ·Phase: NA
-
Obesity Prevention for Pre-Adolescents
NCT00185978 ·Status: COMPLETED ·Phase: PHASE2
-
BEhavioral EConomics for Oral Health iNnovation Trial
NCT03576326 ·Status: COMPLETED ·Phase: NA
-
A Family-Based Weight Loss Intervention for Youth With Intellectual Disability
NCT02033642 ·Status: COMPLETED ·Phase: NA
-
Building Blocks for Healthy Preschoolers
NCT03111264 ·Status: TERMINATED ·Phase: NA
-
A Cluster Randomized Trial of the H2GO! Program
NCT04265794 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
NCT05586269 ·Status: COMPLETED ·Phase: NA
-
Family Based Interventions: Preschool Children and Parent
NCT00024843 ·Status: COMPLETED
-
Parent Mentor Interventions for Early Childhood Obesity
NCT03330743 ·Status: COMPLETED ·Phase: NA
-
Nutrition Study for School Age Children
NCT00620152 ·Status: COMPLETED ·Phase: NA
-
Increased Monitoring of Physical Activity and Calories With Technology
NCT03961061 ·Status: COMPLETED ·Phase: NA
-
Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children
NCT05703347 ·Status: RECRUITING ·Phase: NA
-
The SLeeping and Intake Methods Taught to Infants and Mothers Early in Life (SLIMTIME) Project
NCT00359242 ·Status: COMPLETED ·Phase: PHASE1
-
Behavioral Rx & Nutrition in Pediatric Chronic Disease
NCT01018121 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Community-based Study to Target Childhood Obesity
NCT02890056 ·Status: COMPLETED ·Phase: NA