ASD IhumBrushNCT05552144
Documenting Toothbrushing Experiences of Caregivers Who Care for Children With Autism Spectrum Disorders
An observational study of ASD I and ASD2, run by Colgate Palmolive at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- What is being tested?
- Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 8 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
Study population: 1. 15 children, aged 5-12 years old, male and female with ASD Level I or ASD Level II. 1. ASD Level I requires support 2. ASD Level II requires substantial support 2. Primary caregivers of the children.
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Dental School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder
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).
Read the 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.
- Being tested
- Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871
- Keywords
- autism spectrum disorder, ASD, Smart toothbrush, Caregiver experience
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871Device
Also called Hum by Colgate Smart Manual Kids Toothbrush - 461000001191 (toothbrush), 461000001968 (MAGIK attachment)
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start23 Aug 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ASD IStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine France, DMD, MBE, Principal investigator, Penn Dental School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552144
- Sponsor's protocol ID
- 850364
- Acronym
- humBrush
- Status last verified
- Mar 2024
- First submitted
- 21 Jul 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information may be stored or shared for future research purposes. All the information will be de-identified. All audio recordings will be transcribed and de-identified. De-identified means that all identifiers have been removed. The information could be stored and shared for future research in this de-identified fashion. The information may be shared with other researchers within Penn, or other research institutions, as well as pharmaceutical, device, or biotechnology companies. It would not be possible for future researchers to identify the subjects as we would not share any identifiable information about the subjects with future researchers. This can be done without again seeking their consent in the future, as permitted by law. The future use of the information only applies to the information collected on this study.
Publications
Como DH, Stein Duker LI, Polido JC, Cermak SA. Oral Health and Autism Spectrum Disorders: A Unique Collaboration between Dentistry and Occupational Therapy. Int J Environ Res Public Health. 2020 Dec 27;18(1):135. doi: 10.3390/ijerph18010135.
PubMed 33375475
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Caregivers' Experiences Related to the Use of a Smart Toothbrush by Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05552144
- Acronym / sponsor ID
- humBrush / 850364
- Keywords
- autism spectrum disorder, ASD, Smart toothbrush, Caregiver experience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- 1. 15 children, aged 5-12 years old, male and female with ASD Level I or ASD Level II. 1. ASD Level I requires support 2. ASD Level II requires substantial support 2. Primary caregivers of the children.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hum by Colgate Smart Kids Toothbrush (battery powered) - 490000006871Also: Hum by Colgate Smart Manual Kids Toothbrush - 461000001191 (toothbrush), 461000001968 (MAGIK attachment)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. | Device | – |
Primary outcome
User experiences of hum connected toothbrush as observed by the caregiver with interviews & questionnaires.
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 33375475Como DH, Stein Duker LI, Polido JC, Cermak SA. Oral Health and Autism Spectrum Disorders: A Unique Collaboration between Dentistry and Occupational Therapy. Int J Environ Res Public Health. 2020 Dec 27;18(1):135. doi: 10.3390/ijerph18010135.
- Oral Health and Autism Spectrum Disorders: A Unique Collaboration between Dentistry and Occupational TherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No. All information may be stored or shared for future research purposes. All the information will be de-identified. All audio recordings will be transcribed and de-identified. De-identified means that all identifiers have been removed. The information could be stored and shared for future research in this de-identified fashion. The information may be shared with other researchers within Penn, or other research institutions, as well as pharmaceutical, device, or biotechnology companies. It would not be possible for future researchers to identify the subjects as we would not share any identifiable information about the subjects with future researchers. This can be done without again seeking their consent in the future, as permitted by law. The future use of the information only applies to the information collected on this study.
Related trials for ASD I
Not yet recruitingPhase 1
Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
Autism, Autism Spectrum Disorder
RecruitingObservational study
PTEN Hamartoma Tumor Syndrome Pediatric Patient Registry
PTEN Hamartoma Tumor Syndrome, Macrocephaly Autism Syndrome
Active, not recruitingObservational study
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex (TSC)
Tuberous Sclerosis, Autism Disorder
Active, not recruitingObservational study
Natural History Study of Individuals With Autism and Germline Heterozygous PTEN Mutations
PTEN, ASD
RecruitingPhase 2
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Neurodevelopmental Disorders, Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine France, DMD, MBE principal investigator
Penn Dental School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ASD I and ASD2, run by Colgate Palmolive at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User experiences of hum connected toothbrush as observed by the caregiver with interviews & questionnaires. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05552144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.