AutismSADENCT02077985
Sensory Adapted Dental Environment to Enhance Oral Care for Children With ASD
A study testing Sensory Adapted Dental Environment in people with Autism, run by University of Southern California.
Trial summary
The goal of this project is to collect information that will support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Sensory Adapted Dental Environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Jun 2013
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of autism using ADOS (or) typically developing
- age 6 to 12
- parents speak English or Spanish
- in need of an oral cleaning (no previous cleaning within past four months)
Who cannot join
- disability such as cleft palate, significant motor impairment (e.g cerebral palsy), no genetic, endocrine, or metabolic dysfunction that would interfere with oral care or EDA.
- Additional exclusion for participants in Typical Group include
- diagnosis of ASD or other DD
- diagnosis of ADHD, anxiety disorder, bipolar disorder
- siblings not diagnosed with ASD
About this study
Official title: Sensory Adapted Dental Environment to Enhance Oral Care for Children With Autism
The goal of this project is to collect information that will support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights, smells and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders, and to a lesser extent for typically developing children especially those who have dental anxieties. This has the potential contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
Read the detailed description
The goal of this R34 NIDCR Planning and Pilot Data Grant is to collect information to support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. Within this project, two groups of children were studied: children with autism spectrum disorders (ASD) and typically developing children, including those who are over-reactive to sensory stimulation. Commonly, such children exhibit anxiety and negative behavioral reactions when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. We pilot tested a sensory adapted dental environment (SADE) to examine its effect on reducing anxiety and behavioral problems among the targeted groups of children. The SADE intervention includes such adaptations as dimmed lighting, exposure to soothing music, and application of a special vest which provides deep pressure sensations that are calming. If our preliminary assessment produces promising results, we will later more comprehensively test the intervention in a full-scale randomized clinical trial, which will be supported by a U01 award.
The specific aims of the R34 grant are to promote the ability to conduct the future trial by:
- Developing a manual for the SADE intervention and assessing the intervention's feasibility.
- Collecting preliminary data on the intervention's effectiveness and potential cost-savings.
- Pilot testing the recruitment strategy and assessment battery that will be used in the anticipated trial.
- Developing the system of documents and data management for the future trial.
- Generating the proposal for the U01 award to conduct the planned trial.
Research participants were 45 ethnically diverse children aged 6-12 years, 22 with ASD and 23 who are typically developing. Each child underwent two dental cleanings four months apart: dental cleaning in a standard dental environment and dental cleaning in the sensory adapted environment. For each group of children (i.e., ASD and typically developing), these two conditions were compared in their effects on anxiety and negative behavioral reactions, as measured by videotape coding, psychophysiological indices, and various rating scales.
- Conditions
- Autism
- Being tested
- Sensory Adapted Dental Environment
- Keywords
- autism, electrodermal activity, cooperation, anxiety, distress, stress, oral care, sensory processing, behavior, occupational therapy
- Medical subject headings
- Autistic Disorder, Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Adapted Dental EnvironmentBehavioural
See study arm description.
| Study group | Role | What they receive |
|---|---|---|
| Regular Dental Environment | No intervention | There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual. |
| Sensory Adapted Dental Environment | Experimental | There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations). Receives: Behavioral: Sensory Adapted Dental Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrodermal activity (EDA)
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. EDA was analyzed in two ways in this study to investigate physiological stress/anxiety: (1) tonic skin conductance level (SCL) and (2) frequency of non-specific skin conductance responses (NS-SCR).
Measured: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Secondary outcomes (5)
Children's Dental Behavioral Rating Scale (CDBRS)
The Children's Dental Behavioral Rating Scale (CDBRS) evaluates overt distress behaviors exhibited by children in the dental office. The child's behavior is videotaped during the dental cleaning; the first five minutes of prophylaxis are coded from the video data at a later date. Coding included marking the presence or absence of three distress behaviors (mouth movement, head movement, forehead movement) and the presence or absence and the severity of two distress behaviors (whimper/cry/scream, verbal stall or delay) during each one-minute interval of the five minute video. Significant inter-rater reliability by two trained raters on a sample of children with and without ASD was obtained. The raw score (0-45) was converted, via Rasch analysis, to a scale score of 1-100.
Measured: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded during first five minutes of dental prophylaxis.
Number of hands used to restrain child
The number of hands required to restrain the child during the dental cleaning experience was also utilized as a measure of uncooperative behavior. This variable was recorded on researcher notes during the dental cleaning and was verified using the videotape of the dental cleaning. Scoring included presence/absence as well as the number of hands used for restraint purposes during the cleaning.
Measured: Recorded throughout the dental cleaning (approximately 10-45 minutes)
Frankl Scale
The Frankl Scale was completed by the dentist following the dental cleaning. This one-item Likert Scale ranges from 1 (definitely negative) to 2 (negative) to 3 (positive) to 4 (definitely positive). This assessment has high inter-rater reliability and moderate validity and has been used to measure the behavior of children with ASD.
Measured: Completed at the end of each dental cleaning (approximately 10-45 minutes)
The Anxiety and Cooperation Scale (A & C Scale)
The Anxiety and Cooperation Scale (A \& C Scale) has been shown to assess children's anxiety, fear, and cooperation as rated by dentists, and has good established reliability and validity. Following a routine dental cleaning, the dentist rated overall patient behavior during treatment using a one-item Likert scale ranging from 0 (relaxed, smiling, demonstrates desired behavior, complies with demands) to 5 (out of control, loud crying, reverts to primitive flight responses, physical restraint required).
Measured: Completed at the end of each dental cleaning (approximately 10-45 minutes)
Time
The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.
Measured: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Sharon Cermak, University of Southern California
- Investigators
- Sharon A Cermak, EdD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077985
- Sponsor's protocol ID
- 5R34DE022263-02
- Acronym
- SADE
- Status last verified
- Feb 2014
- First submitted
- 27 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Chaspari T, Tsiartas A, Stein Duker LI, Cermak SA, Narayanan SS. EDA-gram: designing electrodermal activity fingerprints for visualization and feature extraction. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:403-406. doi: 10.1109/EMBC.2016.7590725.
PubMed 28268358Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study. J Autism Dev Disord. 2015 Sep;45(9):2876-88. doi: 10.1007/s10803-015-2450-5.
PubMed 25931290Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC. Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther. 2015 May-Jun;69(3):6903220020p1-10. doi: 10.5014/ajot.2015.013714.
PubMed 25871593Chaspari T, Tsiartas A, Stein LI, Cermak SA, Narayanan SS. Sparse representation of electrodermal activity with knowledge-driven dictionaries. IEEE Trans Biomed Eng. 2015 Mar;62(3):960-71. doi: 10.1109/TBME.2014.2376960. Epub 2014 Dec 4.
PubMed 25494494Stein LI, Lane CJ, Williams ME, Dawson ME, Polido JC, Cermak SA. Physiological and behavioral stress and anxiety in children with autism spectrum disorders during routine oral care. Biomed Res Int. 2014;2014:694876. doi: 10.1155/2014/694876. Epub 2014 Jul 10.
PubMed 25114916
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Adapted Dental Environment to Enhance Oral Care for Children With Autism
- ClinicalTrials.gov ID
- NCT02077985
- Acronym / sponsor ID
- SADE / 5R34DE022263-02
- Conditions
- Autism
- Keywords
- autism, electrodermal activity, cooperation, anxiety, distress, stress, oral care, sensory processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Mar 2014 (estimated)
- 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 goal of this project is to collect information that will support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. We hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights, smells and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders, and to a lesser extent for typically developing children especially those who have dental anxieties. This has the potential contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.
Detailed description
The goal of this R34 NIDCR Planning and Pilot Data Grant is to collect information to support a later clinical trial on the effectiveness of a specially adapted dental environment for children who have difficulty tolerating oral care in the dental clinic. Within this project, two groups of children were studied: children with autism spectrum disorders (ASD) and typically developing children, including those who are over-reactive to sensory stimulation. Commonly, such children exhibit anxiety and negative behavioral reactions when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. We pilot tested a sensory adapted dental environment (SADE) to examine its effect on reducing anxiety and behavioral problems among the targeted groups of children. The SADE intervention includes such adaptations as dimmed lighting, exposure to soothing music, and application of a special vest which provides deep pressure sensations that are calming. If our preliminary assessment produces promising results, we will later more comprehensively test the intervention in a full-scale randomized clinical trial, which will be supported by a U01 award.
The specific aims of the R34 grant are to promote the ability to conduct the future trial by:
- Developing a manual for the SADE intervention and assessing the intervention's feasibility.
- Collecting preliminary data on the intervention's effectiveness and potential cost-savings.
- Pilot testing the recruitment strategy and assessment battery that will be used in the anticipated trial.
- Developing the system of documents and data management for the future trial.
- Generating the proposal for the U01 award to conduct the planned trial.
Research participants were 45 ethnically diverse children aged 6-12 years, 22 with ASD and 23 who are typically developing. Each child underwent two dental cleanings four months apart: dental cleaning in a standard dental environment and dental cleaning in the sensory adapted environment. For each group of children (i.e., ASD and typically developing), these two conditions were compared in their effects on anxiety and negative behavioral reactions, as measured by videotape coding, psychophysiological indices, and various rating scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Dental Environment | No intervention | –There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual. |
| Sensory Adapted Dental Environment | Experimental | Behavioral: Sensory Adapted Dental EnvironmentThere are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of autism using ADOS (or) typically developing
- age 6 to 12
- parents speak English or Spanish
- in need of an oral cleaning (no previous cleaning within past four months)
Key exclusion criteria (5 listed)
- disability such as cleft palate, significant motor impairment (e.g cerebral palsy), no genetic, endocrine, or metabolic dysfunction that would interfere with oral care or EDA.
- Additional exclusion for participants in Typical Group include
- diagnosis of ASD or other DD
- diagnosis of ADHD, anxiety disorder, bipolar disorder
- siblings not diagnosed with ASD
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 |
|---|---|---|
| Sensory Adapted Dental EnvironmentSee study arm description. | Behavioural | Sensory Adapted Dental Environment |
Primary outcome
Electrodermal activity (EDA)
Time frame: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.
Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. EDA was analyzed in two ways in this study to investigate physiological stress/anxiety: (1) tonic skin conductance level (SCL) and (2) frequency of non-specific skin conductance responses (NS-SCR).
5 secondary outcomes
Children's Dental Behavioral Rating Scale (CDBRS)
Time frame: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded during first five minutes of dental prophylaxis.
Number of hands used to restrain child
Time frame: Recorded throughout the dental cleaning (approximately 10-45 minutes)
Frankl Scale
Time frame: Completed at the end of each dental cleaning (approximately 10-45 minutes)
The Anxiety and Cooperation Scale (A & C Scale)
Time frame: Completed at the end of each dental cleaning (approximately 10-45 minutes)
Time
Time frame: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
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 4 Mar 2014.
- Derived from this study: PubMed 28268358Chaspari T, Tsiartas A, Stein Duker LI, Cermak SA, Narayanan SS. EDA-gram: designing electrodermal activity fingerprints for visualization and feature extraction. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:403-406. doi: 10.1109/EMBC.2016.7590725.
- Derived from this study: PubMed 25931290Cermak SA, Stein Duker LI, Williams ME, Dawson ME, Lane CJ, Polido JC. Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study. J Autism Dev Disord. 2015 Sep;45(9):2876-88. doi: 10.1007/s10803-015-2450-5.
- Derived from this study: PubMed 25871593Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC. Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther. 2015 May-Jun;69(3):6903220020p1-10. doi: 10.5014/ajot.2015.013714.
- Derived from this study: PubMed 25494494Chaspari T, Tsiartas A, Stein LI, Cermak SA, Narayanan SS. Sparse representation of electrodermal activity with knowledge-driven dictionaries. IEEE Trans Biomed Eng. 2015 Mar;62(3):960-71. doi: 10.1109/TBME.2014.2376960. Epub 2014 Dec 4.
- Derived from this study: PubMed 25114916Stein LI, Lane CJ, Williams ME, Dawson ME, Polido JC, Cermak SA. Physiological and behavioral stress and anxiety in children with autism spectrum disorders during routine oral care. Biomed Res Int. 2014;2014:694876. doi: 10.1155/2014/694876. Epub 2014 Jul 10.
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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.
Sharon A Cermak, EdD principal investigator
University of Southern California
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Adapted Dental Environment in people with Autism, run by University of Southern California.
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 4 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Electrodermal activity (EDA) (time frame: Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.). 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 NCT02077985, which also lists 5 linked publications.
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 4 Mar 2014.