Happy Teeth for Hopi Tots: Cultural Adaptation of an Oral Health Entertainment-Education Intervention

NCT ID: NCT05297526

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-18
• Study Completion Date: 2023-05-18

Brief Summary

Tooth decay is a preventable disease occurring at high rates among American Indian (AI) populations. The use of entertaining educational materials and cultural adaptation have shown success in improving health behaviors. This trial will test changes in AI parents' knowledge, attitudes and behaviors related to their child(ren)'s oral health after utilizing a culturally adapted children's book/eBook, versus a standard oral health pamphlet developed by the NIH. I hypothesize that the parents in the intervention (book) group will exhibit greater improvement of these measures.

Detailed Description

Early childhood caries (ECC), or the presence of one or more decayed, missing, or filled teeth in children age 5 or younger, is the most chronic childhood disease though it is largely preventable. ECC is most prevalent among American Indian and Alaskan Native (AI/AN) children, with nearly 60% experiencing decay by the age of 3 and over 75% by the age of 5. Oral health is a significant indicator of overall well-being, health, and quality of life, and can have grave impacts on children and their families when disease is not addressed.

Dental decay in primary (baby) teeth can cause pain, damage to the permanent teeth, infection of the head and neck, and difficulty chewing. Severe decay can interfere with intellectual and social development, cause poor speech articulation, embarrassment, low self-esteem, missed days at school, and social isolation. In addition to the physical, psychosocial, and developmental toll on children and their families, treatment for ECC is costly, particularly when hospitalization and general anesthesia are required, which is often the case with severe decay. Because ECC is preventable and can progress quickly, early intervention is a key strategy in reducing its prevalence, particularly in high risk populations.

Interventions utilizing a variety of approaches to address ECC among AI/AN populations have produced mixed results, but few have explored the effect of creative cultural adaptation of oral health education materials on parental knowledge, attitudes, and behaviors regarding the oral health of their children. The use of Entertainment Education (E-E) and specific cultural adaptation of intervention materials have shown success in improving health behaviors of minority and disadvantaged populations. This project will utilize an experimental design using a convenience sample of Hopi parents/caregivers living off Tribal lands, who will be randomized into either the intervention group receiving a culturally adapted children's book celebrating tribal culture with an embedded oral health message, or the control group receiving a standard educational brochure developed by the National Institutes for Health (NIH) for AI/AN. The children's book has electronic book (eBook) and audio narration options for multi-media use and/or those with limited literacy and was illustrated and narrated by Tribal members. Formative assessment data from an ongoing NIH clinical trial involving AI mothers/caregivers and their children in the prevention of ECC (NCT04556175), including Hopi Tribal Community Advisory Board (CAB) meetings, and a review of current literature informed the development of intervention materials (children's book) for this study. The aim of this study is to test the impact of a culturally adapted oral health E-E intervention on the knowledge, attitudes and behaviors of American Indian parents/caregivers related to their child(ren)'s oral health.

The purpose of this research is to identify effective interdisciplinary avenues to reduce the incidence of ECC among AI/AN children. The objective of this study is to compare the effect of a culturally adapted Entertainment-Education intervention on AI parents' knowledge, attitudes, and behaviors pertaining to their children's oral health, to a standard educational brochure developed by the NIH for AI/AN parents.

The main outcome variables will be mean changes from baseline to follow-up in oral health knowledge, beliefs, and behaviors in the intervention group compared to the control group. Post-hoc analyses will be utilized to determine which specific outcome variables (i.e., knowledge, beliefs, or behavior) differed between the groups (primary outcomes).

I hypothesize the that the parents/caregivers in the intervention group will exhibit greater improvement of oral health knowledge, attitudes, and behavior than parents/caregivers in the control group who receive a standard informational pamphlet.

Conditions

Early Childhood Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

The intervention group will receive a culturally adapted children's book that contains the same oral health educational information as the control brochure, but celebrates Tribe-specific culture and utilizes entertainment education. The children's book includes vibrant illustrations by a Tribal artist, and has eBook and audio narration options for multi-media use and/or those with limited literacy.

Group Type: EXPERIMENTAL

Culturally adapted children's book

Intervention Type: BEHAVIORAL

Tribe-specific children's book celebrating tribal culture with an embedded oral health message

Control Group

The control group will receive a standard educational brochure about children's oral health designed by the the National Institutes for Health (NIH) for American Indian/Alaska Native parents.

Group Type: ACTIVE_COMPARATOR

Standard informational brochure on children's oral health

Intervention Type: BEHAVIORAL

Informational brochure about children's oral health designed by the NIH for American Indian/Alaska Native parents.

Interventions

Culturally adapted children's book

Tribe-specific children's book celebrating tribal culture with an embedded oral health message

Intervention Type: BEHAVIORAL

Standard informational brochure on children's oral health

Informational brochure about children's oral health designed by the NIH for American Indian/Alaska Native parents.

Intervention Type: BEHAVIORAL

Other Intervention Names

Education entertainment

Eligibility Criteria

Inclusion Criteria

• Provide signed and dated informed consent form
• Be willing and able to follow study procedures and instructions for the duration of the study (3 months)
• Be at least 18 years of age
• Have access to the internet to complete the consent form, surveys and receive incentives for participation
• Provide a valid mailing address and email address to receive study materials and receive incentives
• Be a parent or caregiver of a child or children under the age of 6 years old.
• Be a member of the Hopi Tribe who does not live on Tribal lands. American Indian status is self-identified-no tribal enrollment verification will be required.
• Not be an enrolled member of the Navajo Tribe, AND
• Not be living on Hopi or Navajo Nations.

Exclusion Criteria

• Are not able to understand or sign a consent form for yourself to participate
• Under 18 years of age
• Do not have access to the internet to complete surveys
• Do not provide a valid mailing address and email address to receive study materials and incentives
• Not a member of the Hopi Tribe
• An enrolled member of the Navajo Tribe
• Living on the Hopi or Navajo Nations

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northern Arizona University

OTHER

Sponsor Role: lead

Responsible Party

Heather Thomas

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Thomas, MEd

Role: PRINCIPAL_INVESTIGATOR

Northern Arizona University

Locations

Dental Hygiene Department, Northern Arizona University

Flagstaff, Arizona, United States

Countries

United States

References

Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.

Reference Type: BACKGROUND

PMID: 28526003 (View on PubMed)

Other Identifiers

1774258-2

Identifier Type: -

Identifier Source: org_study_id