Multi-Media Parent-based Intervention to Promote Dental Hygiene Among Young Children: BeReady2Smile II
- Conditions
- Plaque
- Registration Number
- NCT05321719
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
• 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in parental attitudes towards child tooth brushing and caries T1 (Baseline) and T3 (three month) Four scales are included in the questionnaire that were developed for the international study of Adair and colleagues. Included in this study were:
1. 'Importance and Intention to Brush Child's Teeth' (five items),
2. 'Parental Efficacy in Relation to Child Tooth brushing' (6 items),
3. 'Perceived Seriousness of Tooth Decay in Children' (seven items) and
4. 'Chance Control - Decay Occurs by Chance' (5 items). Response options range from 'strongly agree' (=1) to 'strongly disagree' (=5).
- Secondary Outcome Measures
Name Time Method Knowledge T1 (Baseline) and T3 (three month) As part of the pre- and post-intervention questionnaires, parents will complete a 15-item knowledge inventory of young children's oral health. The items include recommendations for home hygiene and dental health (nine items), statements about the caries process (two items) and dental development (three items). For each item, parents indicated their level of knowledge as 'didn't know', 'sorta know' and 'know for sure'; item scoring ranges from 1 to 3 points, respectively.
Connection to Dental Services "Dental Home" T1 (Baseline) and T3 (three month) The dental home concept has been by the American Academy of Pediatric Dentistry that states, "the dental home is the ongoing relationship between the dentist and the patient, inclusive of all aspects of oral health care delivered in a comprehensive, continuously accessible, coordinated, and family-centered way." This concept is intimately linked to a cluster of additional progressive policies currently being advanced by pediatric dentistry including the age one dental visit, outreach to Head Start populations, updating state Medicaid periodicity schedules, and refining clinical care through risk assessment and risk-based interventions. Parents will be asked to provide past dental services to ascertain the presence of an ongoing relationship with a dentist.
Parents' confidence in brushing T1 (Baseline) and T3 (three month) Investigators will use a Likert scale to determine parents' confidence in brushing their child's teeth twice a day. The question asked was 'If you already don't brush twice a day, how confident are you that, if you decided to, you could brush your child's teeth twice (or almost always twice) a day?' Parents responded on a scale of 1-10 how motivated they are to change this behavior.
Clinical Dental Exam for Plaque T1 (Baseline) and T3 (three month) Children of parents participating in the research will be administered the Plaque Control Record by a Dental Hygienist. The Plaque Control Record was developed to give the therapist, hygienist, or dental educator a simple method of recording the presence of the plaque on individual tooth surfaces: (a) Mesial, (b) Distal (d) Buccal and (d) Lingual. At the exam, a suitable disclosing solution such as Bismarck Brown, Diaplac or similar is painted on all exposed tooth surfaces. After the patient has rinsed, the hygienist (using an explorer or a tip of a probe) examines each stained surface for soft accumulations at the dentogingival junction and are recorded by making a dash in the appropriate spaces on the record form. Those surfaces, which do not have soft accumulations at the dentogingival junction, are not recorded. The index is calculated by dividing the number of plaque containing surfaces by the total number of available surfaces.
Satisfaction of Video and App T2 (one month) and T3 (three month) Parents will rate the video and app on a 4-point scale from 1="not at all" (negative) to 4="Very" (positive). Parents were asked questions such as "How reasonable did you find the Video", "How much did you like the video for learning information taught", "How clear was information taught", "How useful did you find BeReady2Smile" and "I would recommend the BR2S video to other parents".
Usage of Application Once a week through study completion at 12 weeks Throughout the clinical trial all participant activity both online and through the app will be recorded to a MySQL database. Process indicants of acceptability included the following indices of participation: (1) attrition; (2) session completion; and (3) extent of intervention participation (e.g., time online).