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| ID | Type | Description | Link |
|---|---|---|---|
| UG3DE033184 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism | Behavioral | Information provided in arm descriptions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome - long term behavior change | Long-term behavior change measured using the 4-item Behavioral Automaticity Index | 9 months |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
• Children with autism younger than age 10 years will be excluded
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deeksha Nemawarkar | Contact | 206-221-8926 | dnemaw@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Donald Chi, DDS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 11, 2025 | |
| Reset | Jan 2, 2026 | |
| Release | Jan 21, 2026 | |
| Reset | Feb 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 11, 2025 | Jan 2, 2026 | |||
| Jan 21, 2026 |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
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The Investigator and Outcomes Assessor will be blinded to allocation. Both arms will be described as interventions (educational versus behavioral). At the end of the trial children will be able to access the app in the other arm free of charge. The Outcomes Assessor (Statistician) will be masked to group assignment and unblinded only after the final analyses are completed.
| 9 months |
| Feb 9, 2026 |