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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208722
• Other study ID #: STUDY00018248
• Secondary ID: UG3DE033184
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: October 31, 2029

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Deeksha Nemawarkar
• Phone: 206-221-8926
• Email: dnemaw[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: October 31, 2029
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Behavioral:
• Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
Information provided in arm descriptions.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Outcome - long term behavior change	Long-term behavior change measured using the 4-item Behavioral Automaticity Index	9 months
Other	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
Primary	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	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