RECRUITING

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

Conditions

Autism Toothbrushing app Clinical trial Habit formation Evidence based

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-09

Study Completion:2029-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06208722

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Deeksha Nemawarkar

CONTACT

206-221-8926

dnemaw@uw.edu

Principal Investigator

Donald Chi, DDS, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Washington

Donald Chi, DDS, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09

Study Completion Date2029-10-31

Study Record Updates

Study Start Date2024-01-09

Study Completion Date2029-10-31

Terms related to this study

Keywords Provided by Researchers

Toothbrushing app
Clinical trial
Habit formation
Evidence based

Additional Relevant MeSH Terms

Autism