Documenting Toothbrushing Experiences of Caregivers Who Care for Children With Autism Spectrum Disorders

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine caregiver reactions to the use of the hum by Colgate Smart Kids Toothbrush and associated app by children with autism spectrum disorder (ASD).

Detailed Description
-----------------
This is a single-center, pretest-posttest, non-randomized, clinical study involving interviews with caregivers prior to utilization of the research toothbrush and after 4 weeks of product use by the child. All participants enrolled will be children ages 5-12 years and their primary caregivers. Participants will be asked to utilize a Hum by Colgate Smart Kids Toothbrush (manual or battery-powered) for four weeks. To assure that subjects are comfortable with the oral care regime proposed, toothbrushes will be distributed based on the subject's previous oral hygiene habits. Children who are currently using manual brushes will receive the Hum by Colgate Smart Manual Kids Toothbrush, likewise, children who are used to battery-powered toothbrushes will receive the Hum by Colgate Smart Kids battery-powered toothbrush. All the participants will be offered the electric toothbrush and will have a chance to try it during the first visit.

Official Title
-----------------
Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder

Conditions
-----------------
ASD I, ASD2

Intervention / Treatment
-----------------
* Device: Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form by the child's legal guardian on behalf of the child and from the primary (responsible for child's oral healthcare) caregiver. Caregiver must be able to observe the child using the Hum by Colgate Smart Manual Kids Toothbrush and app twice a day. Caregivers must have a child between the ages of 5-12 years old, who is willing to participate. Child must be reported in good general health and good oral health based on the opinion of the study investigator. Caregiver and child must be available for the duration of the study. Caregiver must have access to Apple iPhone (newer than 8) or iPad (newer than 5th generation) or Android users (running Android 6.0 and up) with access to an Internet Connection. Caregiver must be willing to comply with the study protocol. Caregiver must be willing to download and use app associated with the connected brush. Caregiver must be willing to be audiotaped during key informant interview sessions. English fluency for the child's legal guardian/caregiver. Caregiver must be willing to have a shared brushing experience between themselves and the child. Caregiver's child must be diagnosed with ASD Level I or ASD Level II . ASD Level I: Requiring support ASD Level II: Requiring substantial support Exclusion Criteria: Child undergoing active orthodontic treatment with fixed appliances. Child has obvious signs of oral disease, severe dental caries, or pain as determined by the investigator's judgment. Concurrent participation by child in another clinical study. Child's behavior precludes participation in the study at the investigator's discretion. Current or previous use of the Hum by Colgate Smart Kids Toothbrush by the child.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871|The first 15 caregivers and their children who meet the inclusion/exclusion characteristics and sign an Informed Consent Form/provide assent will be entered into the study. The caregivers will be asked to supervise the tooth brushing experience of the children with hum Kids toothbrush twice a day for 4 weeks using the associated app. The caregivers will also be asked to fill out questionnaires and participate in interviews regarding the children's brushing habits and experiences.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User experiences of hum connected toothbrush as observed by the caregiver with interviews & questionnaires. | The hum Smart Kids Toothbrush aims to capture the reactions of the caregivers of the children with ASD on the ease and usefulness of the toothbrush and the app. The goal is to gauge if the experience of using the connected toothbrush is ultimately enjoyable for the caregivers of the children with ASD. Insights from the caregivers will assist in exploring the value of utilizing smart toothbrush technologies for oral hygiene in children with ASD. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASD, autism spectrum disorder, Smart toothbrush, Caregiver experience