Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism
2 other identifiers
interventional
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2023
CompletedStudy Start
First participant enrolled
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2029
ExpectedMay 8, 2024
May 1, 2024
1.2 years
December 22, 2023
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Toothbrushing duration
3 months
Other Outcomes (2)
Exploratory Outcome - long term behavior change
9 months
Exploratory Outcome - oral health quality of life
9 months
Study Arms (2)
Experimental
EXPERIMENTALChildren 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
OTHERThe 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.
Interventions
Information provided in arm descriptions.
Eligibility Criteria
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 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
You may not qualify if:
- Children with autism younger than age 10 years will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Chi, DDS, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor: School of Dentistry
Study Record Dates
First Submitted
December 22, 2023
First Posted
January 17, 2024
Study Start
January 9, 2024
Primary Completion
March 15, 2025
Study Completion (Estimated)
October 31, 2029
Last Updated
May 8, 2024
Record last verified: 2024-05