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NCT Number: NCT06208722

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

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Children with autism younger than age 10 years will be excluded

Treatment and study plan

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

Behavioral

Information provided in arm descriptions.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Toothbrushing duration

    Time frame: 3 months

    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).

Other outcomes

  1. Exploratory Outcome - long term behavior change

    Time frame: 9 months

    Long-term behavior change measured using the 4-item Behavioral Automaticity Index

  2. Exploratory Outcome - oral health quality of life

    Time frame: 9 months

    Oral health quality of life measured using two items from the Child Oral Health Impact Profile-Reduced (COHIP-SF 19)

Study contacts

Contact information is provided by the study sponsor or research team.

Deeksha Nemawarkar

CONTACT

[email protected]

206-221-8926

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jan 17, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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