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

NCT05321719 | Completed

• 2 other identifiers: DE027001-025R44DE027001-03
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque

Outcome Measures

Primary Outcomes (1)

• Change in parental attitudes towards child tooth brushing and caries

  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).

  T1 (Baseline) and T3 (three month)

Secondary Outcomes (7)

• Knowledge

  T1 (Baseline) and T3 (three month)

• Parents' confidence in brushing

  T1 (Baseline) and T3 (three month)

• Connection to Dental Services "Dental Home"

  T1 (Baseline) and T3 (three month)

• Clinical Dental Exam for Plaque

  T1 (Baseline) and T3 (three month)

• Usage of Application

  Once a week through study completion at 12 weeks

Study Arms (2)

Experimental: BeReady2Smile Video, App, & Coach

EXPERIMENTAL

This arm will test the feasibility of the BeReady2Smile Video and App to promote dental health of young children with a parent education program.

Behavioral: Comparison Condition

Assess the Contributions of BRS2 Components

EXPERIMENTAL

Outcomes of video, app, and coach

Behavioral: BeReady2Smile video only; Behavioral: BeReady2Smile video and BeReady2Smile app completely self-guided; Behavioral: "Complete" BeReady2Smile video and BeReady2Smile app guided by a Coach

Interventions

Comparison Condition BEHAVIORAL

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.

Experimental: BeReady2Smile Video, App, & Coach

BeReady2Smile video only BEHAVIORAL

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.

Assess the Contributions of BRS2 Components

BeReady2Smile video and BeReady2Smile app completely self-guided BEHAVIORAL

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.

Assess the Contributions of BRS2 Components

"Complete" BeReady2Smile video and BeReady2Smile app guided by a Coach BEHAVIORAL

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).

Assess the Contributions of BRS2 Components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Research Behavioral Intervention Strategies, Inc.: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, 97477, United States

Location

Related Publications (14)

• American Academy on Pediatric Dentistry Council on Clinical Affairs. Policy on early childhood caries (ECC): unique challenges and treatment option. Pediatr Dent. 2008-2009;30(7 Suppl):44-6. No abstract available.

  PMID: 19216382 BACKGROUND

• Section On Oral Health. Maintaining and improving the oral health of young children. Pediatrics. 2014 Dec;134(6):1224-9. doi: 10.1542/peds.2014-2984.

  PMID: 25422016 BACKGROUND

• Barkley RA. Attention-deficit/hyperactivity disorder, self-regulation, and time: toward a more comprehensive theory. J Dev Behav Pediatr. 1997 Aug;18(4):271-9.

  PMID: 9276836 BACKGROUND

• Brinkmeyer, M., & Eyberg, S. M. (2003). Parent-child interaction therapy for oppositional children. In A.E. Kazdin & J. R. Weisz (Eds.), Evidence-based psychotherapies for children and adolescents (pp. 204-223). New York: Guilford.

  BACKGROUND

• Forgatch, M. S., & Patterson, G. R. (2010). Parent Management Training -- Oregon Model: An intervention for antisocial behavior in children and adolescents. In J. R. Weisz & A. E. Kazdin (Eds.), Evidence based psychotherapies for children and adolescents (2nd ed., pp. 159-178). New York, NY: Guilford.

  BACKGROUND

• Huebner CE, Riedy CA. Behavioral determinants of brushing young children's teeth: implications for anticipatory guidance. Pediatr Dent. 2010 Jan-Feb;32(1):48-55.

  PMID: 20298653 BACKGROUND

• Kazdin AE. Evidence-based treatment and practice: new opportunities to bridge clinical research and practice, enhance the knowledge base, and improve patient care. Am Psychol. 2008 Apr;63(3):146-59. doi: 10.1037/0003-066X.63.3.146.

  PMID: 18377105 BACKGROUND

• Pine CM, Adair PM, Petersen PE, Douglass C, Burnside G, Nicoll AD, Gillett A, Anderson R, Beighton D, Jin-You B, Broukal Z, Brown JP, Chestnutt IG, Declerck D, Devine D, Espelid I, Falcolini G, Ping FX, Freeman R, Gibbons D, Gugushe T, Harris R, Kirkham J, Lo EC, Marsh P, Maupome G, Naidoo S, Ramos-Gomez F, Sutton BK, Williams S. Developing explanatory models of health inequalities in childhood dental caries. Community Dent Health. 2004 Mar;21(1 Suppl):86-95.

  PMID: 15072477 BACKGROUND

• Webster-Stratton, C., & Reid, M. J. (2003). Strengthening social and emotional competence in young children--the foundation for early school readiness and success: Incredible Years Classroom Social Skills and Problem-Solving curriculum. Infants and Young Children, 17(2), 96-113.

  BACKGROUND

• Adair PM, Pine CM, Burnside G, Nicoll AD, Gillett A, Anwar S, Broukal Z, Chestnutt IG, Declerck D, Ping FX, Ferro R, Freeman R, Grant-Mills D, Gugushe T, Hunsrisakhun J, Irigoyen-Camacho M, Lo EC, Moola MH, Naidoo S, Nyandindi U, Poulsen VJ, Ramos-Gomez F, Razanamihaja N, Shahid S, Skeie MS, Skur OP, Splieth C, Soo TC, Whelton H, Young DW. Familial and cultural perceptions and beliefs of oral hygiene and dietary practices among ethnically and socio-economicall diverse groups. Community Dent Health. 2004 Mar;21(1 Suppl):102-11.

  PMID: 15072479 BACKGROUND

• Huebner CE, Milgrom P. Evaluation of a parent-designed programme to support tooth brushing of infants and young children. Int J Dent Hyg. 2015 Feb;13(1):65-73. doi: 10.1111/idh.12100. Epub 2014 Jul 29.

  PMID: 25070036 BACKGROUND

• Edelstein, B. L. (2008). Environmental factors in implementing the dental home for all young children. National Oral Policy Center at Children's Dental Health Project.

  BACKGROUND

• American Academy of Pediatric Dentistry reference manual 2007-2008. Pediatr Dent. 2007-2008;29(7 Suppl):1-271. No abstract available.

  PMID: 18268823 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

Related Links

• Intervention website

MeSH Terms

Conditions

Plaque, Amyloid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David R Smith, PhD

  Oregon Research Behavioral Intervention Strategies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: April 11, 2022
• Study Start: April 10, 2023
• Primary Completion: April 24, 2024
• Study Completion: April 30, 2024
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)