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

Early Childhood Caries Clinical Trial

Official title:

Happy Teeth for Hopi Tots: Cultural Adaptation of an Oral Health Entertainment-Education Intervention to Prevent Early Childhood Caries Among American Indian Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05297526
• Other study ID #: 1774258-2
• Status: Withdrawn
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: May 18, 2023

Study information

• Verified date: May 2023
• Source: Northern Arizona University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Behavioral:
• Culturally adapted children's book
Tribe-specific children's book celebrating tribal culture with an embedded oral health message
• 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.

Locations

Country	Name	City	State
United States	Dental Hygiene Department, Northern Arizona University	Flagstaff	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northern Arizona University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in Oral Health Knowledge after 3 months Intervention	Quantitative changes in knowledge attitudes, and behaviors will be measured using an adapted version of the Basic Research Factors Questionnaire (BRFQ), an instrument developed to assess common risk factors for ECC among high-risk populations (Albino, et al., 2017). The questionnaire will be administered before and after the 3-month intervention via the secure Jefferson REDCap online platform. Increases in oral health knowledge, positive attitudes and reported oral health behaviors indicate a positive outcome.; Measures for Oral health knowledge of parents /caregivers [Time Frame: assessed at baseline and after 3 months.]; Percentage of correct responses to 22 knowledge questions based on the BRFQ (Albino, et al., 2017). There are 11 true/false questions, 8 Likert-type judgements of whether certain behaviors are good for a child's teeth, and 3 multiple choice questions regarding infant/child oral health care. A higher percentage of correct responses indicates a better outcome.	Three months from completion of baseline survey, each participant will fill out the post-study survey.
Primary	Changes from Baseline in Oral Health Attitudes after 3 months Intervention	Measures for Attitudes towards oral health care of parents /caregivers [ Time Frame: assessed at baseline and after 3 months.]; Sum of Likert-type ratings (on a scale of 1-5) for 36 items regarding attitudes toward oral health care. Twenty-four of the items are based upon the Basic Research Factors Questionnaire (Albino, et al., 2017); 12 items measure the importance of oral health care and 12 measure parental/caregiver dental self-efficacy to adhere to oral health care. Twelve study-specific items were added to measure parental caregiver intention to perform the 12 items measured for importance and self-efficacy. Scores range from 36 (lowest) to 180 (highest) with higher scores representing more favorable attitudes towards child oral health care.	Three months from completion of baseline survey, each participant will fill out the post-study survey.
Primary	Changes from Baseline in Oral Health Behaviors after 3 months Intervention	Measures for Oral health behavior of parents/caregivers [Time Frame: assessed at baseline and after 3 months.]; Percentage of correct responses to 22 questions regarding oral health behavior based upon the Basic Research Factors Questionnaire (Albino, et al., 2017). Items include 8 questions regarding dental health care utilization, 10 questions regarding parental oral health care habits for self and child, and 4 questions regarding child's consumption of sweets/sugar. A higher percentage of correct responses indicates a better outcome.	Three months from completion of baseline survey, each participant will fill out the post-study survey.