Happy Teeth for Hopi Tots: Cultural Adaptation of an Oral Health Entertainment-Education Interven… (NCT05297526) | Clinical Trial Compass
WithdrawnNot Applicable
Happy Teeth for Hopi Tots: Cultural Adaptation of an Oral Health Entertainment-Education Intervention
Stopped: Unable to recruite participants due to COVID-19 and other barriers
United States0Started 2022-04-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from Baseline in Oral Health Knowledge after 3 months Intervention
Timeframe: Three months from completion of baseline survey, each participant will fill out the post-study survey.
2
Changes from Baseline in Oral Health Attitudes after 3 months Intervention
Timeframe: Three months from completion of baseline survey, each participant will fill out the post-study survey.
3
Changes from Baseline in Oral Health Behaviors after 3 months Intervention
Timeframe: Three months from completion of baseline survey, each participant will fill out the post-study survey.