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

Enrolling by invitation · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT07446413

Run by

University of Washington

People needed

270

Starts

2026-05-07

Expected to finish

2029-08-31

Last updated by the study team

2026-06-02

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Child participants will have Autism Spectrum Disorder that will be confirmed by: (1) chart review by clinical staff at the recruitment sites to determine if the child meets the DSM-5 criteria for autism spectrum disorder; OR (2) affirmative caregiver self-reporting: (YES) to the question, "Has a healthcare provider ever diagnosed your child with autism?" which has been used in previous studies as a valid method of identifying ASD in children.23,24
• Willingness to take the SRS-2 [Social Responsiveness Scale-2], which will be completed through an online link sent by University of Washington study staff.
• Child brushes independently. The child needs to be able to hold a toothbrush and move it around their teeth, mostly unassisted.
• Child uses touch screen devices (e.g., iPhone, iPad, Android).
• Ages 8 to 17 years at enrollment.
• Caregiver and child able to communicate in English.
• Caregiver age ≥18 years and able to provide informed consent to participate; and willing to provide assent on behalf of a child who is not capable of comprehending the assent process and materials.
• Children ages 8 and older willing to provide assent, if they can comprehend the assent process and materials and communicate a voluntary willingness to participate.
• Caregiver and child live in the same home.
• Caregiver must have a valid and active email address to receive study related materials and study related communications.
• Child has ready access to a mobile device with a front-facing camera onto which apps can be installed (iPad or iPhone with iOS 17.0+; Android tablet or phone with Android 14.0+).
• Family has a Wi-Fi or cellular data plan to allow app data to be transmitted with confirmation of via tools like the Ookla Speed Test to help problem solve and ensure that app data can be transmitted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in the study:
• Children with autism younger than age 8 years at enrollment.
• Children with autism who cannot brush their teeth without assistance (e.g., if caregiver needs to hold the toothbrush).
• Children with autism who have a sibling enrolled in the trial. o For families with more than 1 eligible child with autism, we will enroll the youngest eligible child. Any other children from the same family who are not enrolled in the study will be given access to the app their sibling is using (experimental or control) after 3 months, if they are interested.

Where it is running

• University of Washington School of Dentistry — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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