AutismNCT06208722
Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
A study testing Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism in people with Autism, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2024to 31 Oct 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 10 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 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
Show all 10Show fewer
- 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
Who cannot join
- Children with autism younger than age 10 years will be excluded
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, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Donald L Chi, DDS, PhD, 206-616-4332, Dchi@uw.edu
Deeksha Nemawarkar, BDS, MPH, 6164261422, dnemaw@uw.edu
About this study
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.
Read the 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.
- Conditions
- Autism
- Being tested
- Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
- Keywords
- Toothbrushing app, Clinical trial, Habit formation, Evidence based
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With AutismBehavioural
Information provided in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism |
| Control | Other | 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. Receives: Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start9 Jan 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, 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, Donald Chi, University of Washington
- Investigators
- Donald Chi, DDS, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208722
- Sponsor's protocol ID
- STUDY00018248
- Other IDs
- UG3DE033184
- Status last verified
- May 2024
- First submitted
- 22 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim AS, Collett B, Stobbe G, Stein Duker LI, Ramirez M, Mancl L, Jacobson D, Nemawarkar D, Orack J, Li SR, Chi DL. Protocol for a randomized controlled trial of an app-based intervention to improve toothbrushing skills and habits in autistic children and adolescents. Contemp Clin Trials. 2026 Sep 27:108480. doi: 10.1016/j.cct.2026.108480. Online ahead of print.
PubMed 42801973
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
- ClinicalTrials.gov ID
- NCT06208722
- Acronym / sponsor ID
- STUDY00018248
- Conditions
- Autism
- Keywords
- Toothbrushing app, Clinical trial, Habit formation, Evidence based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 17 Jan 2024 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With AutismChildren 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. |
| Control | Other | Behavioral: Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With AutismThe 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 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 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
Key exclusion criteria (1 listed)
- Children with autism younger than age 10 years will be excluded
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 |
|---|---|---|
| Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With AutismInformation provided in arm descriptions. | Behavioural | Control, Experimental |
Primary outcome
Toothbrushing distribution
Time frame: 3 months
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.
1 secondary outcome
Toothbrushing duration
Time frame: 3 months
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 8 May 2024.
- Derived from this study: PubMed 42801973Kim AS, Collett B, Stobbe G, Stein Duker LI, Ramirez M, Mancl L, Jacobson D, Nemawarkar D, Orack J, Li SR, Chi DL. Protocol for a randomized controlled trial of an app-based intervention to improve toothbrushing skills and habits in autistic children and adolescents. Contemp Clin Trials. 2026 Sep 27:108480. doi: 10.1016/j.cct.2026.108480. Online ahead of print.
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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.
Donald Chi, DDS, PhD 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 Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism in people with Autism, 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 10 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 May 2024. 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. 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?
Contact Deeksha Nemawarkar (206-221-8926, dnemaw@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toothbrushing distribution (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06208722, which also lists 1 linked publication.
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 8 May 2024.