Autism Spectrum DisorderBUNCT07446413
Mobile App-Based Intervention to Improve Toothbrushing in Children and Teens With Autism
A study testing Brush Up App and Brush Down App in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Brush Up App and Brush Down App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Washington School of Dentistry
Seattle, Washington, 98195
About this study
Official title: Testing a Mobile App-Based Intervention to Improve Toothbrushing Skills and Habits in Children and Teens With Autism
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:
Read more
- Will toothbrushing distribution, duration, and frequency be greater in the experimental arm than in the control arm?
- Will toothbrushing habit formation be higher in the experimental arm than in the control arm?
- Is caregiver and child self-efficacy a mediator of toothbrushing habit formation?
- Do children who exhibit habit formation report better oral health-related quality of life?
Participants will:
- Use either the autism-friendly app or the control app during their daily toothbrushing routine for 3 months.
- Complete surveys and assessments about toothbrushing behaviors and oral health over the course of the study.
Read the detailed description
The UH3 RCT will be conducted over four years. We will obtain a list of eligible participants from the main study recruitment site (Seattle Children's Hospital). We will obtain a list of individuals who express interest in participating in the study from other recruitment sites. UW staff will contact potential participants, describe the study, verify interest and screen for eligibility, and obtain informed consent and assent. The caregiver and their child/teen, aged 8-17 years, will be enrolled (N=270) as dyads and randomly assigned (1:1) to an experimental or control arm, accounting for sex and autism severity. The study participation will span one year. The participants in both arms will follow the same procedures.
After enrollment, caregivers from both control and experimental groups will complete all surveys according to the determined schedules. Caregivers will complete a demographics survey and a toothpaste survey via phone. Caregivers will also complete an online survey, Social Responsiveness Scale-2 (SRS-2), via WPS Publishing, to provide data on the user's autism severity. Before the app use, caregivers will be asked to complete a 9-item Oral Health Behavior Survey (OHBS), 30-item Behavioral Survey (BS) and 38-item Short Sensory Profile (SSP) via REDCap at baseline.
Caregivers will then be given a unique link to install a modified Brush Up/Brush Down app, depending on their assignment in the experimental or control arm respectively. The Brush Up app (experimental) features a cartoon character that helps guide the child through toothbrushing with a catchy song. It also includes a digital mirror where the child can watch themselves brush and a matching game where they earn stars by matching their toothbrushing movements with the character. The Brush Down app (control) includes only a digital screen mirror and a timer. We will ask the user to use the app twice a day for 3 months. The app will record the user's toothbrushing sessions. Users will be made aware of this during consent/assent process. The 9-item OHBS will be re-administered at 1 month, 2 months and 3 months of app use via REDCap. The 30-item BS will be re-administered at 2 weeks, 1 month, 2 months, and 3 months of app use via REDCap. Study staff will recruit 60 dyads (N=30 from each arm) for a post-trial debriefing interview lasting about 60 minutes using a semi-structured interview script to elicit responses about the experiences of using the app, the effects of the app on their child's long-term toothbrushing habit formation as well as ways the intervention could be further strengthened in the future to meet the needs of individuals with autism. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods.
After 3 months of app use, the caregivers will be asked to complete a 6-item BS, an abridged version of a 30-item BS, to assess long-term habit formation and oral health quality of life from months 4 to 12 of participation via REDCap.
Study staff will reach out to the dyads who participated in post-trial interviews to obtain feedback on their experiences of using the app. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Brush Up App, Brush Down App
- Keywords
- Autism Spectrum Disorder, Toothbrushing habits, Mobile App based intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brush Up AppBehavioural
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.
Brush Down AppBehavioural
The Brush Down app provides health education module, a digital screen mirror and a countdown timer. This app does not include autism-friendly features.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Dyads in the experimental arm will use the modified, experimental version of the app (Brush Up) twice a day for 3 months. Receives: 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. Receives: Behavioral: Brush Down App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary outcome will be measured based on data from week 12 of the 3-month trial.
Secondary outcomes (2)
Toothbrushing duration
Toothbrushing duration refers to the mean number of seconds brushed per toothbrushing episode. For each subject, one toothbrushing episode per day will be randomly sampled during week12 to measure this outcome. For each sampled episode, the duration will be measured in seconds from the time toothbrushing commences until toothbrushing concludes. Idle time, which is defined as time not spent actively brushing during an episode will also be measured in seconds.
Measured: The secondary outcome will be measured based on data from week 12 of the 3-month trial.
Toothbrushing Frequency
Toothbrushing frequency refers to the number of days the app was used at least twice per day. Timestamps will be recorded for each instance of toothbrushing with the app, which will be used to determine the number of days for measuring frequency.
Measured: The secondary outcome will be measured based on data from week 12 of the 3-month trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 May 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Amy Kim, University of Washington
- Investigators
- Amy Kim, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446413
- Sponsor's protocol ID
- STUDY00022501
- Other IDs
- UH3DE033184
- Acronym
- BU
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Mobile App-Based Intervention to Improve Toothbrushing Skills and Habits in Children and Teens With Autism
- ClinicalTrials.gov ID
- NCT07446413
- Acronym / sponsor ID
- BU / STUDY00022501
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Toothbrushing habits, Mobile App based intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will toothbrushing distribution, duration, and frequency be greater in the experimental arm than in the control arm?
- Will toothbrushing habit formation be higher in the experimental arm than in the control arm?
- Is caregiver and child self-efficacy a mediator of toothbrushing habit formation?
- Do children who exhibit habit formation report better oral health-related quality of life?
Participants will:
- Use either the autism-friendly app or the control app during their daily toothbrushing routine for 3 months.
- Complete surveys and assessments about toothbrushing behaviors and oral health over the course of the study.
Detailed description
The UH3 RCT will be conducted over four years. We will obtain a list of eligible participants from the main study recruitment site (Seattle Children's Hospital). We will obtain a list of individuals who express interest in participating in the study from other recruitment sites. UW staff will contact potential participants, describe the study, verify interest and screen for eligibility, and obtain informed consent and assent. The caregiver and their child/teen, aged 8-17 years, will be enrolled (N=270) as dyads and randomly assigned (1:1) to an experimental or control arm, accounting for sex and autism severity. The study participation will span one year. The participants in both arms will follow the same procedures.
After enrollment, caregivers from both control and experimental groups will complete all surveys according to the determined schedules. Caregivers will complete a demographics survey and a toothpaste survey via phone. Caregivers will also complete an online survey, Social Responsiveness Scale-2 (SRS-2), via WPS Publishing, to provide data on the user's autism severity. Before the app use, caregivers will be asked to complete a 9-item Oral Health Behavior Survey (OHBS), 30-item Behavioral Survey (BS) and 38-item Short Sensory Profile (SSP) via REDCap at baseline.
Caregivers will then be given a unique link to install a modified Brush Up/Brush Down app, depending on their assignment in the experimental or control arm respectively. The Brush Up app (experimental) features a cartoon character that helps guide the child through toothbrushing with a catchy song. It also includes a digital mirror where the child can watch themselves brush and a matching game where they earn stars by matching their toothbrushing movements with the character. The Brush Down app (control) includes only a digital screen mirror and a timer. We will ask the user to use the app twice a day for 3 months. The app will record the user's toothbrushing sessions. Users will be made aware of this during consent/assent process. The 9-item OHBS will be re-administered at 1 month, 2 months and 3 months of app use via REDCap. The 30-item BS will be re-administered at 2 weeks, 1 month, 2 months, and 3 months of app use via REDCap. Study staff will recruit 60 dyads (N=30 from each arm) for a post-trial debriefing interview lasting about 60 minutes using a semi-structured interview script to elicit responses about the experiences of using the app, the effects of the app on their child's long-term toothbrushing habit formation as well as ways the intervention could be further strengthened in the future to meet the needs of individuals with autism. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods.
After 3 months of app use, the caregivers will be asked to complete a 6-item BS, an abridged version of a 30-item BS, to assess long-term habit formation and oral health quality of life from months 4 to 12 of participation via REDCap.
Study staff will reach out to the dyads who participated in post-trial interviews to obtain feedback on their experiences of using the app. The interviews will be audio recorded, transcribed, and verified for accuracy, and coded deductively using standard methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Brush Up AppDyads in the experimental arm will use the modified, experimental version of the app (Brush Up) twice a day for 3 months. |
| Control | Placebo comparator | Behavioral: Brush Down AppDyads assigned to the control arm will use the control version of the app (Brush Down) twice-per-day for 3-months. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brush Up AppThe 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. | Behavioural | Experimental |
| Brush Down AppThe Brush Down app provides health education module, a digital screen mirror and a countdown timer. This app does not include autism-friendly features. | Behavioural | Control |
Primary outcome
Toothbrushing distribution
Time frame: The primary outcome will be measured based on data from week 12 of the 3-month trial.
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.
2 secondary outcomes
Toothbrushing duration
Time frame: The secondary outcome will be measured based on data from week 12 of the 3-month trial.
Toothbrushing Frequency
Time frame: The secondary outcome will be measured based on data from week 12 of the 3-month trial.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Kim, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brush Up App and Brush Down App in people with Autism Spectrum Disorder, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toothbrushing distribution (time frame: The primary outcome will be measured based on data from week 12 of the 3-month trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.