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

NCT05297526 | Withdrawn

• 1 other identifier: 1774258-2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Oral Health; Health Knowledge, Attitudes, Practice; Health Education, Dental; American Indian; Dental Caries; Cultural Adaptation

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Culturally adapted children's book

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Standard informational brochure on children's oral health

Interventions

Culturally adapted children's book BEHAVIORAL

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

Also known as: Education entertainment

Intervention Group

Standard informational brochure on children's oral health BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Arizona University: lead

Study Sites (1)

Dental Hygiene Department, Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related 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.

  PMID: 28526003 BACKGROUND

MeSH Terms

Conditions

Behavior; Health Education; Dental Caries

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Heather Thomas, MEd

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked as to which group they have been randomized into for the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Model Details: After completing the consent and baseline survey, participants will be randomized into either the control group or the intervention group via Jefferson REDCap. Participants will not know which group they are in, and will receive the corresponding materials for their group to use for the duration of the study (3 months). At the end of the 3 month period, participants will take a post-study survey to gauge changes in knowledge, attitudes, and behaviors regarding oral health. At the end of the trial, participants who were in the control group receiving just the informational pamphlet, will receive a copy of the baby book given to the intervention group.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: April 18, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)