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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism
• Intervention / Treatment: Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism

Detailed Description

Adolescents with autism are at increased risk for tooth decay in part because of poor diet and toothbrushing habits. Effective ways to reduce added sugar intake have yet to be tested, but technologies exist to help improve toothbrushing. Mobile health apps are a promising but underutilized way to improve and enforce toothbrushing habits. Many adolescents with autism are enamored with technology and own devices that support apps. We propose a Stage II efficacy trial in modifying a toothbrushing app and inform behavior change in the target population.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deeksha Nemawarkar; Phone Number: 206-221-8926; Email: dnemaw@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Donald L Chi, DDS, PhD; Phone Number: 206-616-4332; Email: Dchi@uw.edu
      • Contact: Deeksha Nemawarkar, BDS, MPH; Phone Number: 6164261422; Email: dnemaw@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism; Information provided in arm descriptions.
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.	Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism; Information provided in arm descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toothbrushing distribution	The primary outcome is toothbrushing distribution, defined as the mean proportion of total tooth surfaces in the mouth that are brushed during the last month of the 3-month trial.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toothbrushing duration	Toothbrushing duration (mean number of seconds brushed per toothbrushing episode during the last month of the 3-month trial) and frequency (number of days during the last month of the 3-month trial in which the app was used at least twice/day).	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome - long term behavior change	Long-term behavior change measured using the 4-item Behavioral Automaticity Index	9 months
Exploratory Outcome - oral health quality of life	Oral health quality of life measured using two items from the Child Oral Health Impact Profile-Reduced (COHIP-SF 19)	9 months

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Donald Chi, DDS, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Clinical trial; Habit formation; Toothbrushing app; Evidence based
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: STUDY00018248; UG3DE033184 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No