Mobile App-Based Intervention to Improve Toothbrushing in Children and Teens With Autism

NCT07446413 | Not Yet Recruiting

• 2 other identifiers: STUDY00022501UH3DE033184
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test whether the autism-friendly app improves toothbrushing outcomes compared to a control app with only a digital mirror and countdown timer among children and teens (ages 8-17 years) with autism. The main questions it aims to answer are:

1. 1.Will toothbrushing distribution, duration, and frequency be greater in the experimental arm than in the control arm?
2. 2.Will toothbrushing habit formation be higher in the experimental arm than in the control arm?
3. 3.Is caregiver and child self-efficacy a mediator of toothbrushing habit formation?
4. 4.Do children who exhibit habit formation report better oral health-related quality of life?
5. 5.Use either the autism-friendly app or the control app during their daily toothbrushing routine for 3 months.
6. 6.Complete surveys and assessments about toothbrushing behaviors and oral health over the course of the study.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Toothbrushing habits; Mobile App based intervention

Outcome Measures

Primary Outcomes (1)

• Toothbrushing distribution

  The primary outcome being measured is toothbrushing distribution. Toothbrushing distribution refers to the mean proportion of different tooth surfaces in the mouth that should be brushed during each toothbrushing episode (i.e., lingual, buccal occlusal). For each subject, one toothbrushing episode per day will be randomly sampled during week 12 to measure distribution.

  The primary outcome will be measured based on data from week 12 of the 3-month trial.

Secondary Outcomes (2)

• Toothbrushing duration

  The secondary outcome will be measured based on data from week 12 of the 3-month trial.

• Toothbrushing Frequency

  The secondary outcome will be measured based on data from week 12 of the 3-month trial.

Other Outcomes (7)

• Exploratory Outcomes

  App use during Weeks 1, 2, 4, 8, and 12 during the 3-month trial.

• Exploratory Outcome

  App use during weeks 1, 2, 4, 8, and 12 during the 3-month trial.

• Exploratory Outcome

  App use from baseline to end of month 3.

Study Arms (2)

Experimental

EXPERIMENTAL

Dyads in the experimental arm will use the modified, experimental version of the app (Brush Up) twice a day for 3 months.

Behavioral: Brush Up App

Control

PLACEBO COMPARATOR

Dyads assigned to the control arm will use the control version of the app (Brush Down) twice-per-day for 3-months.

Behavioral: Brush Down App

Interventions

Brush Up App BEHAVIORAL

The Brush Up app is an autism-friendly mobile app modified to improve toothbrushing skills and habits in children with autism spectrum disorder and includes a health education module, a cartoon role model, toothbrushing instructional song, digital screen mirror, and customizable app features.

Experimental

Brush Down App BEHAVIORAL

The Brush Down app provides health education module, a digital screen mirror and a countdown timer. This app does not include autism-friendly features.

Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 self-reporting: (YES) to the question, "Has a healthcare provider ever diagnosed your child with autism?" which has been used in previous studies as a valid method of identifying ASD in children.23,24
• Willingness to take the SRS-2 \[Social Responsiveness Scale-2\], which will be completed through an online link sent by University of Washington study staff.
• Child brushes independently. The child needs to be able to hold a toothbrush and move it around their teeth, mostly unassisted.
• Child uses touch screen devices (e.g., iPhone, iPad, Android).
• Ages 8 to 17 years at enrollment.
• Caregiver and child able to communicate in English.
• Caregiver age ≥18 years and able to provide informed consent to participate; and willing to provide assent on behalf of a child who is not capable of comprehending the assent process and materials.
• Children ages 8 and older willing to provide assent, if they can comprehend the assent process and materials and communicate a voluntary willingness to participate.
• Caregiver and child live in the same home.
• Caregiver must have a valid and active email address to receive study related materials and study related communications.
• Child has ready access to a mobile device with a front-facing camera onto which apps can be installed (iPad or iPhone with iOS 17.0+; Android tablet or phone with Android 14.0+).
• 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in the study:
• Children with autism younger than age 8 years at enrollment.
• Children with autism who cannot brush their teeth without assistance (e.g., if caregiver needs to hold the toothbrush).
• Children with autism who have a sibling enrolled in the trial. o For families with more than 1 eligible child with autism, we will enroll the youngest eligible child. Any other children from the same family who are not enrolled in the study will be given access to the app their sibling is using (experimental or control) after 3 months, if they are interested.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Washington School of Dentistry

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Donald L Chi, DDS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua C Orack, MPH

CONTACT

2066164923; jcorack@uw.edu

Amy S Kim, DDS

CONTACT

2065430407; akim3@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessing team including the coders and the lead will be masked in the clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean and Professor: School of Dentistry, Oral Health Sciences

Model Details: This is a 2-arm Stage II efficacy trial. Children and teens with autism and their caregivers (N=270 dyads) will be enrolled and randomly assigned (1:1) to an experimental or control arm, accounting for sex and autism severity. Dyads assigned to the experimental arm will use the modified, experimental version of the app (Brush Up) with a cartoon role model, digital screen mirror and a game, twice-per-day for 3-months. Dyads assigned to the control arm will use the control version of the app (Brush Down) with only a digital screen mirror and countdown timer twice-per-day for 3-months.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)