Mobile App-Based Intervention to Improve Toothbrushing in Children and Teens With Autism (NCT07446413) | Clinical Trial Compass
By InvitationNot Applicable
Mobile App-Based Intervention to Improve Toothbrushing in Children and Teens With Autism
United States270 participantsStarted 2026-05-07
Plain-language 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.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Toothbrushing distribution
Timeframe: The primary outcome will be measured based on data from week 12 of the 3-month trial.
. 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.