Mobile App for Toothbrushing in Teens with Autism

Overseen By Deeksha Nemawarkar

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Children under age 10

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. We have 2 specific aims: * During the 2-year UG3 phase, we will use the Discover, Design+Build, and Test Framework to modify our existing app and pilot the intervention. * During the 4-year UH3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes. Participants will asked to use the app, complete surveys on REDCap, participate in feedback interviews and focus groups. Behavior change in the experimental group will be compared with that in the control group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the mobile app for toothbrushing in teens with autism safe?

The studies reviewed did not report any safety concerns related to using mobile apps or technology-based interventions for improving toothbrushing in children with autism. These interventions were generally well-received and showed positive outcomes in oral hygiene without mentioning any adverse effects. ^{1 2 3 4 5}

How is the Mobile Toothbrushing App for Teens with Autism different from other treatments for autism?

The Mobile Toothbrushing App for Teens with Autism is unique because it uses a mobile app to improve toothbrushing skills and habits, leveraging technology to provide visual and interactive guidance, which is different from traditional methods like social stories or video modeling. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism?

Research shows that using video modeling and tablet-based programs can improve oral hygiene in children with autism. Studies found that these methods, including internet-based interventions, led to better toothbrushing habits and oral health compared to traditional methods. ^{1 2 5 6 7}

Who Is on the Research Team?

Donald Chi, DDS, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for teens aged 10-17 with Autism Spectrum Disorder who brush their teeth mostly unassisted, use touch screen devices, and live with a caregiver. The caregiver must be over 18 and able to consent in English. Participants need access to a mobile device with a camera and internet connection.

Inclusion Criteria

The child and caregiver live together in the same home.

Children who use smartphones or tablets.

I am over 18 and can consent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

UG3 Phase

Modification of the existing app and pilot intervention using the Discover, Design+Build, and Test Framework

2 years

UH3 Phase

Recruitment of 270 pre-adolescents and teens with autism, randomization to two arms, and comparison of outcomes

4 years

Treatment

Participants use the app during toothbrushing 2x a day for 3 months under direct supervision of the caregiver

3 months

Regular app usage and survey completion at 2 weeks, 1 month, 2 months, and 3 months

Follow-up

Participants are monitored for long-term behavior change and oral health quality of life

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism

Trial Overview The study tests an app designed to improve toothbrushing skills in autistic teens against a control app. Over six years, it will modify the existing app, pilot it during the first two years, then compare behavior changes between groups using surveys and interviews.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Children in the experimental arm will receive the same health education module as in the control arm. They will also receive a brief tutorial on additional app components in the form of a digital social story, which is an effective way to convey information to children with autism. Participants will be completing 26-item Behavioral Survey at 2 weeks, 1 month, 2 month, and 3 month. Participants will be using the app during toothbrushing 2x a day for 3 months under direct supervision of the caregiver.

Group II: Control Experimental Treatment 1 Intervention

The control arm will consist of a 20-second health education module delivered through the control app that consists of a digital selfie mirror and a timer that matches the length of brushing time in the experimental app. Participants will be completing all the survey activities similar to that of the participants in the experimental arm.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

A study involving 137 students with autism spectrum disorders (ASD) showed that a tooth-brushing educational intervention using video modeling significantly improved oral hygiene status compared to traditional social story methods.

After one month, the improvement in oral hygiene, measured by the Simplified Oral Hygiene Index (OHI-S), was notably greater in the video modeling group, indicating that modern educational techniques can be more effective for individuals with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Story Based Toothbrushing Education Versus Video-Modeling Based Toothbrushing Training on Oral Hygiene Status Among Male Students Aged 7-15 Years Old with Autism Spectrum Disorders in Tehran, Iran: A Quasi-Randomized Controlled Trial. Piraneh, H., Gholami, M., Sargeran, K., et al.[2023]

Both video modeling (VM) and toothbrushing social story (TSS) interventions significantly improved oral hygiene in children with autism spectrum disorder (ASD) after 30 days, as measured by plaque and gingival indices.

Caregivers reported greater acceptance of daily oral hygiene practices in the VM group compared to the TSS group, suggesting that VM may be a more effective method for encouraging oral hygiene in children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative evaluation of video modeling and social stories for improving oral hygiene in children with autism spectrum disorder: A pilot study. Gandhi, R., Jackson, J., Puranik, CP.[2023]

A four-month tooth brushing learning program using pictograms on an iPad significantly improved tooth brushing skills in 52 children with autism spectrum disorder (ASD), aged 3 to 19 years.

The program not only enhanced the children's ability to brush their teeth but also increased their interaction with the iPad, suggesting that technology can be an effective tool for teaching oral hygiene to children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Teaching tooth brushing to children with autistic spectrum disorder : A tablet-based training programme.] Lefer, G., Bourdon, P., Mercier, C., et al.[2019]

An iPad®-based training program significantly improved toothbrushing behaviors in 52 children and teenagers with autism spectrum disorder (ASD) over an 8-month period.

The program not only enhanced the children's autonomy in oral care but also made it easier for caregivers to implement effective toothbrushing routines, as shown by significant improvements in all assessed variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toothbrushing training programme using an iPad&#174; for children and adolescents with autism. Lopez Cazaux, S., Lefer, G., Rouches, A., et al.[2020]

A randomized control trial involving 18 children with autism tested a 3-week internet-based video-modeling intervention for improving oral hygiene, showing that both the intervention and control groups improved their oral health.

However, the children in the Intervention group demonstrated significantly larger improvements in their oral hygiene, suggesting that video modeling could be an effective method for enhancing at-home oral care in children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Remotely Delivered Video Modeling for Improving Oral Hygiene in Children with ASD: A Pilot Study. Popple, B., Wall, C., Flink, L., et al.[2019]

The MyDentist project, which involved 59 children with autism spectrum disorder (ASD), successfully improved oral hygiene and cooperation during dental treatments over a 6-month period using Information and Communication Technologies (ICT) for desensitization and fear control.

Parents reported high acceptability of the MyDentist experience, indicating that effective dental care for children with ASD can be achieved through innovative, non-pharmacological approaches, reducing the need for costly medications with potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Mom Let's Go to the Dentist!" Preliminary Feasibility of a Tailored Dental Intervention for Children with Autism Spectrum Disorder in the Italian Public Health Service. Narzisi, A., Bondioli, M., Pardossi, F., et al.[2023]

A study involving 30 children with autism spectrum disorder (ASD) showed that using visual pedagogy significantly improved toothbrushing ability and cooperation over a 6-month period.

Children with mild ASD demonstrated better toothbrushing skills and cooperation compared to those with moderate ASD, indicating that the severity of ASD may influence the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Visual Pedagogy for Toothbrushing in Children with Autism Spectrum Disorder. Smutkeeree, A., Khrautieo, T., Thamseupsilp, S., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Social Story Based Toothbrushing Education Versus Video-Modeling Based Toothbrushing Training on Oral Hygiene Status Among Male Students Aged 7-15 Years Old with Autism Spectrum Disorders in Tehran, Iran: A Quasi-Randomized Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A comparative evaluation of video modeling and social stories for improving oral hygiene in children with autism spectrum disorder: A pilot study. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Teaching tooth brushing to children with autistic spectrum disorder : A tablet-based training programme.] [2019]

4. England pubmed.ncbi.nlm.nih.gov

Toothbrushing training programme using an iPad&#174; for children and adolescents with autism. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Remotely Delivered Video Modeling for Improving Oral Hygiene in Children with ASD: A Pilot Study. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

"Mom Let's Go to the Dentist!" Preliminary Feasibility of a Tailored Dental Intervention for Children with Autism Spectrum Disorder in the Italian Public Health Service. [2023]

7. India pubmed.ncbi.nlm.nih.gov

The Effectiveness of Visual Pedagogy for Toothbrushing in Children with Autism Spectrum Disorder. [2022]