Tooth Book Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in psychosocial construct scores relevant to tooth donation
研究概览
简要总结
Study Overview Primary ("baby") teeth are unique biological samples because they can permanently store information about a child's early life health and development. While donating baby teeth to scientific research is painless and simple, researchers often face challenges collecting them. Past studies show that donation rates are particularly low among racial minority groups and lower-income families, even though these populations may experience higher rates of early-life adversity and could benefit greatly from this research. Currently, very little is known about what influences a parent's willingness to donate their child's teeth.
This study evaluates whether an educational tool can bridge this gap. Researchers will use a children's book and video called "The Science Tooth Fairy" to see if explaining the importance of tooth donation can positively change parents' attitudes and willingness to participate in scientific research.
Study Objectives and Hypotheses The main goal of this research is to investigate parental attitudes toward donating their children's baby teeth and to see if educational materials can encourage participation.
The study is testing two main hypotheses:
- Primary Hypothesis: Parents who interact with "The Science Tooth Fairy" materials (either the book, video, or both) will show a greater positive shift in their attitudes toward tooth donation compared to parents who read a standard oral health book that does not mention research.
- Secondary Hypothesis: "The Science Tooth Fairy" story's content and delivery format (book, video, or both) influence parental engagement with and understanding of the intervention materials.
Study Design and Procedures This is a randomized controlled trial aiming to recruit approximately 120 parents or legal guardians of children aged 4 to 10. Recruitment will take place in diverse clinical spaces (such as pediatric and dental clinics) and public events to ensure a representative sample. The entire study takes about 30 to 45 minutes to complete in a single session.
Participants will be randomly assigned to one of four groups:
- Group 1: Read a printed copy of "The Science Tooth Fairy" book.
- Group 2: Watch a video version of "The Science Tooth Fairy".
- Group 3: Watch the video and have the option to read the printed book.
- Group 4 (Control Group): Read a standard children's book about oral health ("Cavities vs. Toothpaste"), which contains no mention of research or donation.
The step-by-step participation process includes:
- Informed Consent: Reviewing and signing the study consent form.
- Pre-Assessment Survey: A 14-item questionnaire evaluating current trust in medical research and attitudes toward biological donations.
- The Intervention: Completing the reading or viewing activity assigned during randomization.
- Post-Assessment Survey: An identical 14-item questionnaire to measure changes in attitude, along with a background demographics survey.
By comparing survey responses before and after the activity, researchers hope to learn how to design future recruitment strategies.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Biological or non-biological parents (e.g., legal caregivers or guardians) of children aged 4-10 years
排除标准
- •Reports feeling uncomfortable reading and listening to materials
- •Prior exposure to the STF book or video.
结局指标
主要结局
Change in psychosocial construct scores relevant to tooth donation
时间窗: Thirty minutes before intervention (pre-intervention) and within 30 minutes of completion of the intervention (post-intervention)
To measure primary outcomes we developed a survey by adapting validated psychometric scales assessing psychosocial factors that are relevant to primary tooth donation. The same survey was applied before and after the assigned intervention.
次要结局
- Post-intervention psychosocial construct scores relevant to parental engagement with the intervention materials(Within 30 minutes of intervention completion)
研究者
Erin Dunn
Associate Professor of Psychiatry
Massachusetts General Hospital
