Clinical trial NCT05321719: Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile II
Official title: Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-11
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

• Have a child 0-6 years enrolled in a participating social service agency providing parent education, such as Head Start; be able to communicate in English or Spanish.

Exclusion Criteria: Individuals who meet the following criteria will be excluded from the study:

* Parental psychosis or other major mental illness or cognitive disability that would interfere with meaningful participation
* Babies without teeth
* Children with allergies to food dye.

Primary outcomes:
measure: Change in parental attitudes towards child tooth brushing and caries
timeFrame: T1 (Baseline) and T3 (three month)
Secondary outcomes:
measure: Knowledge
timeFrame: T1 (Baseline) and T3 (three month)
measure: Parents' confidence in brushing
timeFrame: T1 (Baseline) and T3 (three month)
measure: Connection to Dental Services "Dental Home"
timeFrame: T1 (Baseline) and T3 (three month)
measure: Clinical Dental Exam for Plaque
timeFrame: T1 (Baseline) and T3 (three month)
measure: Usage of Application
timeFrame: Once a week through study completion at 12 weeks
measure: Satisfaction of Video and App
timeFrame: T2 (one month) and T3 (three month)
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Oregon Research Behavioral Intervention Strategies, Inc.
state: Oregon
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies, Inc.
name: David R Smith, PhD
role: PRINCIPAL_INVESTIGATOR
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