The Science Tooth Fairy: A Randomized Trial of a Storytelling-Based Educational Intervention to Promote Primary Tooth Donation in a Pediatric Setting (STF RCT)

Background and Significance

Teeth are a unique type of biospecimen that can permanently hold information about health across the lifespan, unlike other types of biospecimen like blood, nails, and hair. Primary or "baby" teeth specifically can contain information about early life development 1-3 because they start to form during a sensitive period of brain development9-10. The study of primary teeth can show exposure to early childhood adversity and other relevant developmental markers.

Teeth are becoming a more common type of biospecimen donation to research because the natural removal of them is pain-free, they are widely available, and they do not require specialized storage protocols. Although there are many benefits to teeth donation to science, researchers have experienced mixed success in collecting teeth relative to other biospecimens11-13. Further, there is research to show that tooth donation rates appear even lower in minority and disadvantaged groups12,16. Yet, these groups may experience early-life adversity at higher prevalence14-15. Little research has been conducted to identify why there is this disparity in tooth donation.

The first step to explore the factors that determine tooth donation is to understand willingness and attitudes for this type of biospecimen collection. Based on the current literature, there are multiple known factors that affect donation of non-tooth biospecimen to research studies4-8. Some factors that are potentially modifiable include trust in research and security of participants' personal health information4,5,8,17-19, knowledge about donation5-7, and beliefs that donations benefit future generations5,8. Some potentially non-modifiable factors that affect biospecimen donation are education status6,18,20 and religious or cultural beliefs. However, there are little studies that have investigated parents' attitudes and beliefs about donating their children's primary teeth to science.

To better understand the attitudes and willingness of parents to donate their children's primary teeth to science, parent and child pairs will be introduced to an educational book called "The Science Tooth Fairy", and their views will be assessed. This children's book, written by Dr. Dunn and team and being used in the STRONG Study (protocol 2019P003570), highlights the importance of tooth donation to research and explains the process of donation. We are hoping to understand factors that influence tooth donation so we can alter recruitment strategies and address concerns earlier in future studies to boost participation.

2. Specific Aims and Objectives

Here, we aim to investigate parental attitudes and willingness to donate tooth, specifically, children's exfoliated teeth. We would like to investigate the extent to which a children's book about teeth donations can encourage participation in research. There is little research examining parent's attitudes and beliefs about donating their children's primary teeth.

We hypothesize that participants who read "The Science Tooth Fairy" book will have a positive shift in attitudes about donation primary teeth to science. After the educational intervention, they will be more open to the idea of donating primary teeth to biomedical research than the group that reads the control book. Further, we also hypothesize that attitudes will be more shifted positively for participants who are more unlikely to donate biospecimen to research (people of color and lower socioeconomic status12,16 ).

3. General Description of Study Design

This study is a pre-post research design with an educational intervention. The intervention (book or video) will be used to assess if attitudes on biospecimen donation will change with education about the topic. This is a randomized controlled study with four possible interventions:

1. Read printed copy of the "The Science Tooth Fairy" book (n=25)
2. Watch video of "The Science Tooth Fairy" video (n=25)
3. Watch the "The Science Tooth Fairy" video and have the option to also read the book (n=25)
4. Read "Cavities vs.Toothpaste" book about oral health (n=25). This control children's book does not include any information about tooth donation or research studies.

We hope to recruit up to 120 participants to this study. The entire participation process will be about 30-45 minutes which includes the consent process, demographics survey, pre-test, intervention, post-test, and another demographics survey. The pre and post-test contain the same questions.

4. Subject Selection

Participants eligible for this research study include parents of children who are between the ages of 4-10 years old. In this study, parents will be defined as a caregiver or guardian to a child, including biological children and non-biological children. Non-English-speaking parents will be excluded from this study due to language of the intervention and survey and funding limitations on translating the book into other languages at this time. Eligible participants will be identified at the pediatrics clinics including at MGH Revere HealthCare Center, and other clinical spaces at Mass General Brigham including pediatric dental clinics, public events held such as the Cambridge Science Festival and other outside MGB clinical practices as available to us. About 120 participants will be recruited.

We will be recruiting in diverse spaces, including the Revere clinic, as we hope to recruit from minority populations to help us understand disparities in tooth donation from a diverse sample. We will be primarily recruiting at pediatric and pediatric dental clinics because of the increased volume of parents with children within our desired age range and our collaboration with clinicians in this clinic.

In a clinic setting, the study staff will help identify eligible participants a couple days in advance. Eligible participants will be handed a flyer by the clinic's front-desk staff or study staff. In the waiting room, study staff will be visible with signage introducing the study. Providers will also present the study to eligible participants after their appointment and hand them a flyer. If interested, the provider will provide a warm hand-off to the study staff in the waiting room. Our study staff will then go over consent documents and begin participation in the study.

Recruitment at public events such as the Cambridge Science Festival will involve handing a flyer to parents with children in the right age range. If interested, we will proceed with the consent and study as outlined.

5. Subject Enrollment

Potential participants will be identified by study staff and clinic front-desk staff to see if they meet eligibility criteria. The study staff/front-desk staff will give eligible participants a flyer to introduce the study and present the study-staff in the waiting room. In clinics, if the parent is eligible, the pediatrician will also introduce the research study through a flyer. If the participant is interested to participate in the study, the provider or staff member will introduce the participant to a clinical research coordinator. The clinical research coordinator will lead the participant to a private room in the clinic or remain in the waiting area if the participant is comfortable participating in an only semi-private space. In public event spaces, the interviews will be done in as private a space as possible. We believe those participants who will read the book may be able to participate in the waiting area/in public spaces. This will aid the study staff as there may not be enough private space to have two participants completing the study at the same time.

The clinical research coordinator will go through the consent information with the participant immediately before any study procedures. The clinical research coordinator will be available for any questions or clarifications needed. Consent forms will be signed on RedCap or using a paper copy, whichever is preferred by the participant.

After consent is documented, the participant's intervention will be assigned through a randomization method. This randomization method will be done through Redcap to determine which of the four intervention groups the participant will be assigned. Once assignment to one of the groups occurs, the participants will then be given the first questionnaire.

6. STUDY PROCEDURES

Participation in this study will last 30-45 minutes and will be completed in one-sitting. During this time period, the consent document will be presented and signed, the randomized assignment to one of the four intervention groups will take place, the demographic questionnaire will be completed, the pre-test will be administered, the intervention will be given, and the post-test will be administered. Study enrollment will cease when the participant leaves the clinic or if they decide to opt-out at any time during the process. Participation in this study will not interfere with patient care with the clinic.

Once recruited, the study procedures are as follows:

1. Consent obtained
2. Demographics Survey: asking if participants have joined a research study before or if they have ever donated any biospecimen to science
3. Pre-assessment: 14 items looking at attitudes towards biomedical research and teeth donation
4. Intervention
5. Post-assessment: 14 items identical to the pre-test

6. Demographics Survey: asking about age, race, ethnicity, educational attainment, employment status, annual household income, marital status, number of children cared for.

   The pre- and post- assessments contain the same items, and the possible answers are on a 5-point Likert scale. The order of the items will not be identical for both assessments. If uncomfortable, participants can choose to refrain from answering any questions by selecting "prefer not to answer." Surveys will either be filled out directly into RedCap by participants on iPads or on a paper-copy with the help of a clinical research coordinator.

   The items asked in the pre- and post- intervention assessments are compiled from previously established measures and scales used in other research studies. These include the Biobanking Attitudes and Knowledge Survey21, the Helping Attitudes Scale23, and the Biomedical Research Trust Scale22. Some items from these scales were modified to become more easily accessible for participants in our study.

   Participants will be randomly assigned to one of the aforementioned intervention groups by the randomization feature in RedCap. After assignment, the parents will be given the intervention: either a printed-copy book or video to be watched on the iPad or both. We expect parents will read the books to their child and/or watch the video with their child, however this is not necessary for the study.

   Participants will be compensated for their participation in the study after completion of all surveys. They will have the option of a $20.00 gift card from Target or Stop & Shop. We will also give them a copy of The Science Tooth Fairy book as a gift. They will be given this compensation before they leave the clinic. Participation in the study will be terminated if the participant does not want to continue. If a participant decides to withdraw before completion of the tasks, we will still offer them The Science Tooth Fairy book as a gift.

   The primary outcome of this study is to see a difference in attitudes about biospecimen donation, but specifically primary teeth donation. Using the preestablished measures and scales, we will identify changes by comparing the intervention group with the control to see if attitudes change. A secondary outcome of this study is to see if there are more pronounced differences within groups based on demographic information provided or prior beliefs about tooth donation.

7. Risks and Discomforts

   Participants will be informed that there are no foreseeable physical risks from this research study.

   Participants may feel slightly uncomfortable completing some of the questionnaires. Participants will be reminded that they are not required to answer any questions that make them feel uncomfortable and are able to withdraw their participation at any time.

8. Benefits

   Participants will be informed that there may be no direct benefit from participation in this research study. However, they will be informed that the information learned from this study may provide insight into different attitudes about primary teeth donation and trust in medical research.

9. Statistical Analysis

   To test our primary hypotheses, we will compare our four groups in terms of the outcome measures to determine what level of change occurred post- versus pre-intervention. For these analyses, we will calculate change scores for each outcome measure and use regression analysis to identify the predictors of those change scores, using the four groups as our predictor variables. Depending on demographic differences in these groups at baseline (i.e., if randomization worked), we may or may not include social-demographic factors as covariates in the analysis. This regression will allow us to quantify the direction and magnitude of change across groups. Further, to test our secondary hypothesis, we will additionally examine the role of social-demographics as possible predictors of our analysis. We expect that with 30 participants per group we will have at least 80% statistical power to detect a change across groups (comparing all groups to each other).

10. Monitoring and Quality Assurance

We don't foresee any adverse events as a result of taking part in this study. If an adverse event does occur, they will be documented and reported to the IRB by the PI.