NCT06208722Recruiting
Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
Source: ClinicalTrials.gov · Last updated 8 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 22 Dec 2023
- Start date
- 9 Jan 2024
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- University of Washington
- Diseases
- Autism
- NCT number
- NCT06208722
What you commit to
- Study type: Interventional
- Planned participants: 270
- From 9 Jan 2024 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Children with autism younger than age 10 years will be excluded
Who the study is looking for
- 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 response (YES) to the question, "Has a healthcare provider ever diagnosed your child with autism?"
- Willingness to take a CARS-2 \[Childhood Autism Rating Scale-2\], which will be administered by trained staff
- Child brushes independently \[The child needs to be able to hold the toothbrush and move it around their teeth, mostly unassisted\]
- Child uses touch screen devices (e.g.,smartphones or tablet)
- Ages 10 to 17 years at enrollment
- Caregiver and child able to communicate in English
- Caregiver age ≥18 years and able to provide informed consent in English
- Child and caregiver live in the same home
- Child has ready access to a mobile device with a front-facing camera onto which apps can be downloaded (iPad or iPhone with iOS 16.0+; Android tablet or phone with Android 13.0+)
- 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
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
Related publications
- Protocol for a randomized controlled trial of an app-based intervention to improve toothbrushing skills and habits in autistic children and adolescents.Contemp Clin Trials · 2026 · PMID 42801973
This page is information, not medical advice. Discuss any trial with your doctor.