Contemporary clinical trials · 2026
Protocol for a randomized controlled trial of an app-based intervention to improve toothbrushing skills and habits in autistic children and adolescents.
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Kim Amy S, Collett Brent, Stobbe Gary, Stein Duker Leah I, Ramirez Magaly, Mancl Lloyd, Jacobson Dov, Nemawarkar Deeksha, Orack Joshua, Li Sophie R, Chi Donald L
Аннотация
BACKGROUND: Autistic children and teens are at increased risk of tooth decay, due in part to difficulties with daily toothbrushing routines. There is a dearth of sociobehavioral interventions that specifically support oral health maintenance in this population. BrushUp is a mobile app aimed at improving toothbrushing skills and habits in children.
METHODS: This project is a 2-arm randomized controlled trial (RCT) that will enroll 270 autistic children and teens ages 8 to 17 years and their caregivers as dyads. Children and teens will be randomized to the experimental or control arm consisting of the BrushUp or BrushDown app, respectively, to be used twice a day for 3 months. BrushUp incorporates concepts from Video Self Modeling and includes a health education module, digital screen mirror, cartoon role model, and autism-friendly features. BrushDown includes a health education module, digital screen mirror, and a countdown timer. The study's goal is to compare toothbrushing outcomes among participants in the two arms. The primary outcome is toothbrushing distribution (defined as the mean proportion of total tooth surfaces brushed per toothbrushing episode) and secondary outcomes are toothbrushing duration and frequency. Analyses will follow an intent-to-treat approach.
DISCUSSION: This study will be among the first RCTs to evaluate a mobile app-based intervention tailored for autistic children and teens to improve toothbrushing habits. Findings from our study will also produce novel mechanism data to show how apps can help with habit formation.
TRIAL REGISTRATION: ClinicalTrials.govNCT06208722 (first posted on 12/22/2023).
METHODS: This project is a 2-arm randomized controlled trial (RCT) that will enroll 270 autistic children and teens ages 8 to 17 years and their caregivers as dyads. Children and teens will be randomized to the experimental or control arm consisting of the BrushUp or BrushDown app, respectively, to be used twice a day for 3 months. BrushUp incorporates concepts from Video Self Modeling and includes a health education module, digital screen mirror, cartoon role model, and autism-friendly features. BrushDown includes a health education module, digital screen mirror, and a countdown timer. The study's goal is to compare toothbrushing outcomes among participants in the two arms. The primary outcome is toothbrushing distribution (defined as the mean proportion of total tooth surfaces brushed per toothbrushing episode) and secondary outcomes are toothbrushing duration and frequency. Analyses will follow an intent-to-treat approach.
DISCUSSION: This study will be among the first RCTs to evaluate a mobile app-based intervention tailored for autistic children and teens to improve toothbrushing habits. Findings from our study will also produce novel mechanism data to show how apps can help with habit formation.
TRIAL REGISTRATION: ClinicalTrials.govNCT06208722 (first posted on 12/22/2023).