Early Childhood CariesNCT05297526
Happy Teeth for Hopi Tots: Cultural Adaptation of an Oral Health Entertainment-Education Intervention
A study testing Culturally adapted children's book and Standard informational brochure on children's oral health in people with Early Childhood Caries, run by Northern Arizona University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Culturally adapted children's book and Standard informational brochure on children's oral health
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 18 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dental Hygiene Department, Northern Arizona University
Flagstaff, Arizona, 86011
About this study
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
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.
Read the 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
- Being tested
- Culturally adapted children's book, Standard informational brochure on children's oral health
- Keywords
- Oral Health, Health Knowledge, Attitudes, Practice, Health Education, Dental, American Indian, Dental Caries, Cultural Adaptation
- Medical subject headings
- Behavior, Health Education, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted children's bookBehavioural
Also called Education entertainment
Tribe-specific children's book celebrating tribal culture with an embedded oral health message
Standard informational brochure on children's oral healthBehavioural
Informational brochure about children's oral health designed by the NIH for American Indian/Alaska Native parents.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard informational brochure on children's oral health |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Three months from completion of baseline survey, each participant will fill out the post-study survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start18 Apr 2022
- Primary completion18 May 2023
- Study completion18 May 2023
Why it stopped: Unable to recruite participants due to COVID-19 and other barriers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Thomas, Northern Arizona University
- Investigators
- Heather Thomas, MEd, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297526
- Sponsor's protocol ID
- 1774258-2
- Status last verified
- May 2023
- First submitted
- 17 Mar 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28526003
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05297526
- Acronym / sponsor ID
- 1774258-2
- Conditions
- Early Childhood Caries
- Keywords
- Oral Health, Health Knowledge, Attitudes, Practice, Health Education, Dental, American Indian, Dental Caries, Cultural Adaptation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruite participants due to COVID-19 and other barriers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Culturally adapted children's bookThe 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. |
| Control Group | Active comparator | Behavioral: Standard informational brochure on children's oral healthThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted children's bookAlso: Education entertainmentTribe-specific children's book celebrating tribal culture with an embedded oral health message | Behavioural | Intervention Group |
| Standard informational brochure on children's oral healthInformational brochure about children's oral health designed by the NIH for American Indian/Alaska Native parents. | Behavioural | Control Group |
Primary outcome
Changes from Baseline in Oral Health Knowledge after 3 months Intervention
Time frame: Three months from completion of baseline survey, each participant will fill out the post-study survey.
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.
Changes from Baseline in Oral Health Attitudes after 3 months Intervention
Time frame: Three months from completion of baseline survey, each participant will fill out the post-study survey.
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.
Changes from Baseline in Oral Health Behaviors after 3 months Intervention
Time frame: Three months from completion of baseline survey, each participant will fill out the post-study survey.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 28526003Albino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Thomas, MEd principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted children's book and Standard informational brochure on children's oral health in people with Early Childhood Caries, run by Northern Arizona University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Oral Health Knowledge after 3 months Intervention (time frame: Three months from completion of baseline survey, each participant will fill out the post-study survey.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.