Clinical trial NCT06208722: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
Official title: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Keywords: Toothbrushing app
Clinical trial
Habit formation
Evidence based
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-01-17
Enrollment: 270
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly selected in the experimental and the control arm. Participants in the experimental arm will use the experimental app while those in the control arm will use the control app. Participants will receive all surveys in the same format and frequency in both arms.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Toothbrushing distribution
timeFrame: 3 months
Secondary outcomes:
measure: Toothbrushing duration
timeFrame: 3 months
Other outcomes:
measure: Exploratory Outcome - long term behavior change
timeFrame: 9 months
measure: Exploratory Outcome - oral health quality of life
timeFrame: 9 months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Donald Chi, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: