NCT07446413

Mobile App-Based Intervention to Improve Toothbrushing in Children and Teens With Autism

Testing a Mobile App-Based Intervention to Improve Toothbrushing Skills and Habits in Children and Teens With Autism

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test whether the autism-friendly app improves toothbrushing outcomes compared to a control app with only a digital mirror and countdown timer among children and teens (ages 8-17 years) with autism. The main questions it aims to answer are: 1. Will toothbrushing distribution, duration, and frequency be greater in the experimental arm than in the control arm? 2. Will toothbrushing habit formation be higher in the experimental arm than in the control arm? 3. Is caregiver and child self-efficacy a mediator of toothbrushing habit formation? 4. Do children who exhibit habit formation report better oral health-related quality of life? Participants will: 1. Use either the autism-friendly app or the control app during their daily toothbrushing routine for 3 months. 2. Complete surveys and assessments about toothbrushing behaviors and oral health over the course of the study.

Detailed description

The UH3 RCT will be conducted over four years. We will obtain a list of eligible participants from the main study recruitment site (Seattle Children's Hospital). We will obtain a list of individuals who express interest in participating in the study from other recruitment sites. UW staff will contact potential participants, describe the study, verify interest and screen for eligibility, and obtain informed consent and assent. The caregiver and their child/teen, aged 8-17 years, will be enrolled (N=270) as dyads and randomly assigned (1:1) to an experimental or control arm, accounting for sex and autism severity. The study participation will span one year. The participants in both arms will follow the same procedures. After enrollment, caregivers from both control and experimental groups will complete all surveys according to the determined schedules. Caregivers will complete a demographics survey and a toothpaste survey via phone. Caregivers will also complete an online survey, Social Responsiveness Scale-2 (SRS-2), via WPS Publishing, to provide data on the user's autism severity. Before the app use, caregivers will be asked to complete a 9-item Oral Health Behavior Survey (OHBS), 30-item Behavioral Survey (BS) and 38-item Short Sensory Profile (SSP) via REDCap at baseline. Caregivers will then be given a unique link to install a modified Brush Up/Brush Down app, depending on their assignment in the experimental or control arm respectively. The Brush Up app (experimental) features a cartoon character that helps guide the child through toothbrushing with a catchy song. It also includes a digital mirror where the child can watch themselves brush and a matching game where they earn stars by matching their toothbrushing movements with the character. The Brush Down app (control) includes only a digital screen mirror and a timer. We will ask the user to use the app twice a day for 3 months. The app will record the user's toothbrushing sessions. Users will be made aware of this during consent/assent process. The 9-item OHBS will be re-administered at 1 month, 2 months and 3 months of app use via REDCap. The 30-item BS will be re-administered at 2 weeks, 1 month, 2 months, and 3 months of app use via REDCap. Study staff will recruit 60 dyads (N=30 from each arm) for a post-trial debriefing interview lasting about 60 minutes using a semi-structured interview script to elicit responses about the experiences of using the app, the effects of the app on their child's long-term toothbrushing habit formation as well as ways the intervention could be further strengthened in the future to meet the needs of individuals with autism. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods. After 3 months of app use, the caregivers will be asked to complete a 6-item BS, an abridged version of a 30-item BS, to assess long-term habit formation and oral health quality of life from months 4 to 12 of participation via REDCap. Study staff will reach out to the dyads who participated in post-trial interviews to obtain feedback on their experiences of using the app. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Brush Up App	The Brush Up app is an autism-friendly mobile app modified to improve toothbrushing skills and habits in children with autism spectrum disorder and includes a health education module, a cartoon role model, toothbrushing instructional song, digital screen mirror, and customizable app features.
BEHAVIORAL	Brush Down App	The Brush Down app provides health education module, a digital screen mirror and a countdown timer. This app does not include autism-friendly features.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-08-31
• Completion: 2029-08-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States