634 Participants Needed

Motivational Techniques for Preventing Tooth Decay in Children

(BTCF Trial)

Recruiting at 15 trial locations
KW
JB
Overseen ByJennifer Bowman-Reif, MS
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Iowa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Self-determination theory (SDT) for preventing tooth decay in children?

Research shows that using Self-determination theory (SDT) in dental care can improve motivation and oral health behaviors, leading to better dental attendance and reduced dental plaque in children and adolescents. This suggests that SDT can be effective in preventing tooth decay by encouraging better oral hygiene practices.12345

Is the Self-Determination Theory (SDT) approach safe for use in humans?

The studies using the Self-Determination Theory (SDT) approach for dental health interventions do not report any safety concerns, suggesting it is generally safe for use in humans.12346

How does the treatment using Self-Determination Theory (SDT) differ from other treatments for preventing tooth decay in children?

The treatment using Self-Determination Theory (SDT) is unique because it focuses on enhancing motivation by supporting autonomy, which means encouraging children and their caregivers to make their own informed choices about dental care. This approach is different from standard treatments that may not emphasize personal motivation and decision-making as a key component of preventing tooth decay.12347

What is the purpose of this trial?

Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the disease burden. The likelihood of parents of high-ECC risk young children seeking prevention in dental facilities is low; therefore, there is a need to increase preventive dental opportunities where these children already seek health care services. In particular, there is an urgent need to develop and evaluate ECC behavioral interventions for use in public health settings attended by high-risk children. Many authors recommend early implementation of oral health education as one means of preventing ECC. However, major issues discussed in the oral health promotion literature involve a lack of effectiveness among programs based on education alone, as well as a lack of high quality preventive interventions using evidence-based psychological and behavioral strategies.Our research team has been the first to introduce to the ECC prevention arena the self-determination theory (SDT) of motivation, internalization, and healthy functioning, proven effective in promoting positive behavioral changes in several other fields, including oral health care. The investigators have demonstrated that SDT has great promise as a motivational approach by providing evidence, based on results from our R21 (R21-DE016483) study, of the effectiveness of SDT in changing several desirable oral health behaviors for ECC prevention. Building upon the rigor of our previous experience and formative research work in the past several years, the investigators propose a Stage II NIH Model research project that will compare the efficacy of autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral videotaped messages. The investigators intend to recruit 634 pregnant mothers enrolled in Iowa Women, Infants and Children (WIC) Supplemental Nutrition Programs and follow them until their future child is 36 months old. The primary outcome of interest will be children's caries status. Secondary outcomes will be changes in children's oral health behaviors conducive to better oral hygiene and dietary habits, as well as lower levels of dental plaque and mutans streptococci.

Research Team

KW

Karin Weber-Gasparoni, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for pregnant women aged 18-45, enrolled in the WIC program, who are between 12 and 32 weeks into their pregnancy. They must understand English or Spanish and plan to stay in the area for at least 4 years. Women who give birth before the first study visit cannot participate.

Inclusion Criteria

I can speak, understand, and read English or Spanish.
I am a pregnant woman aged 18-45 and participate in WIC.
Between 12 and 32 weeks of the gestational period
See 1 more

Exclusion Criteria

Mothers who deliver their child prior to their first study intervention visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pregnant mothers receive autonomy-supportive or neutral oral health messages during pregnancy, and at 12 and 24 months of child's age

36 months
3 visits (in-person) at pregnancy, 12 months, and 24 months

Follow-up

Mothers receive follow-up booster messages 3 months after each oral health message, and children's oral health outcomes are monitored

36 months
4 visits (in-person) at 12, 24, and 36 months, with additional activities at 1 and 9 months between site visits

Treatment Details

Interventions

  • Self-determination theory
Trial Overview The trial tests if motivational videos based on self-determination theory can improve oral health behaviors to prevent early childhood cavities. It compares these videos against traditional neutral messages from pregnancy until the child turns three.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: SDTExperimental Treatment1 Intervention
Pregnant mothers will be randomly assigned to either an experimental group (Group 1) where mothers will receive autonomy-supportive messages informed by the SDT or a control group (Group 2) where mothers will receive the same oral health care messages delivered using a neutral style. All mothers will be exposed to oral health messages - one during pregnancy, one later when their child is 12 months of age, and one when their child is 24 months of age. Three months after receiving the oral health messages at each time point, mothers will be sent a follow-up booster message.
Group II: ControlExperimental Treatment1 Intervention
Pregnant mothers will be randomly assigned to either an experimental group (Group 1) where mothers will receive autonomy-supportive messages informed by the SDT or a control group (Group 2) where mothers will receive the same oral health care messages delivered using a neutral style. All mothers will be exposed to oral health messages - one during pregnancy, one later when their child is 12 months of age, and one when their child is 24 months of age. Three months after receiving the oral health messages at each time point, mothers will be sent a follow-up booster message.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

Findings from Research

A Self-Determination Theory (SDT) intervention significantly improved patients' caries competence and dental attendance compared to standard care, as shown in a study with 138 participants over 5.5 months.
The study found that patients' sense of autonomy (measured by relative autonomous locus of causality, RALOC) and the supportive approach of dental hygienists were key factors in reducing dental anxiety and increasing attendance for dental care.
Predicting dental attendance from dental hygienists' autonomy support and patients' autonomous motivation: A randomised clinical trial.Halvari, AE., Halvari, H., Williams, GC., et al.[2018]
The study involving 322 students found that providing autonomy support at dental clinics leads to greater patient satisfaction and motivation, which in turn increases dental attendance and improves oral health.
Conversely, conditional regard from dental staff can create frustration and anxiety, leading to avoidance of dental appointments and negatively impacting oral health.
Attending and avoiding dental appointments: Do "bright" and "dark" motivational paths have a role?Münster Halvari, AE., Halvari, H., Deci, EL.[2022]
A dental intervention that promotes patient autonomy significantly improved perceived clinician support and increased patients' motivation for dental care, leading to better dental behaviors over 5.5 months in a study of 141 patients.
The intervention resulted in very large reductions in dental plaque and gingivitis, highlighting its effectiveness compared to standard care and suggesting important implications for improving dental health practices.
Self-determined motivational predictors of increases in dental behaviors, decreases in dental plaque, and improvement in oral health: a randomized clinical trial.Münster Halvari, AE., Halvari, H., Bjørnebekk, G., et al.[2022]

References

Predicting dental attendance from dental hygienists' autonomy support and patients' autonomous motivation: A randomised clinical trial. [2018]
Attending and avoiding dental appointments: Do "bright" and "dark" motivational paths have a role? [2022]
Self-determined motivational predictors of increases in dental behaviors, decreases in dental plaque, and improvement in oral health: a randomized clinical trial. [2022]
An effective psychoeducational intervention for early childhood caries prevention: part I. [2021]
Self-determination theory guided oral self-care training for adolescents-A cluster randomised controlled trial. [2023]
Development and evaluation of the Motivation to Limit Screen-time Questionnaire (MLSQ) for adolescents. [2019]
An effective psychoeducational intervention for early childhood caries prevention: part II. [2021]
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