Clinical trial NCT02077985: Sensory Adapted Dental Environment to Enhance Oral Care for Children With ASD
Official title: Sensory Adapted Dental Environment to Enhance Oral Care for Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: autism
electrodermal activity
cooperation
anxiety
distress
stress
oral care
sensory processing
behavior
occupational therapy
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
First posted: 2014-03-04
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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:

1. Developing a manual for the SADE intervention and assessing the intervention's feasibility.
2. Collecting preliminary data on the intervention's effectiveness and potential cost-savings.
3. Pilot testing the recruitment strategy and assessment battery that will be used in the anticipated trial.
4. Developing the system of documents and data management for the future trial.
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Electrodermal activity (EDA)
timeFrame: 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:
measure: Children's Dental Behavioral Rating Scale (CDBRS)
timeFrame: Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded during first five minutes of dental prophylaxis.
measure: Number of hands used to restrain child
timeFrame: Recorded throughout the dental cleaning (approximately 10-45 minutes)
measure: Frankl Scale
timeFrame: Completed at the end of each dental cleaning (approximately 10-45 minutes)
measure: The Anxiety and Cooperation Scale (A & C Scale)
timeFrame: Completed at the end of each dental cleaning (approximately 10-45 minutes)
measure: Time
timeFrame: Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Sharon A Cermak, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cermak 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.
citation: Cermak 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.
citation: Chaspari 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.
citation: Stein 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.