Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06208722
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Testing a Mobile App to Improve Toothbrushing Skills and Habits in Teens With Autism — BEHAVIORAL
    Information provided in arm descriptions.

Study Details

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.

Key Dates

Start date
Jan 9, 2024
Status verified
May 2024
Primary completion
Mar 15, 2025
Completion
Oct 31, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • Other: Control
    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.

Primary Outcome Measure

Toothbrushing distribution [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Donald L Chi, DDS, PhD
206-616-4332
Deeksha Nemawarkar, BDS, MPH
6164261422

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