Recruiting

Mobile App

Sponsor:

University of Washington

Code:

NCT06208722

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Autism

Study ID

NCT06208722

Start date

Jan 9, 2024

Status verified date

May, 2024

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Mar 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

• Children with autism younger than age 10 years will be excluded

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental

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.

other: Control

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.

Interventions

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

Information provided in arm descriptions.

Primary outcome measure

  • Toothbrushing distribution [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Deeksha Nemawarkar

206-221-8926dnemaw@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Donald L Chi, DDS, PhD

206-616-4332Dchi@uw.edu

Deeksha Nemawarkar, BDS, MPH

6164261422dnemaw@uw.edu

More Information

Sponsor

University of Washington

Last update posted

May 8, 2024

Last verified

May, 2024

Keywords

  • Toothbrushing app
  • Clinical trial
  • Habit formation
  • Evidence based

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Washington on 2024-05-08.