Sensory Adapted Dental Environment to Enhance Oral Care for Children With ASD

NCT02077985 | Completed

• 1 other identifier: 5R34DE022263-02
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism

Keywords

autism; electrodermal activity; cooperation; anxiety; distress; stress; oral care; sensory processing; behavior; occupational therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded during first five minutes of dental prophylaxis.

• Number of hands used to restrain child

  Recorded throughout the dental cleaning (approximately 10-45 minutes)

• Frankl Scale

  Completed at the end of each dental cleaning (approximately 10-45 minutes)

• The Anxiety and Cooperation Scale (A & C Scale)

  Completed at the end of each dental cleaning (approximately 10-45 minutes)

• Time

  Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit

Study Arms (2)

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).

Behavioral: Sensory Adapted Dental Environment

Interventions

Sensory Adapted Dental Environment BEHAVIORAL

See study arm description.

Sensory Adapted Dental Environment

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• diagnosis of ASD or other DD
• diagnosis of ADHD, anxiety disorder, bipolar disorder
• siblings not diagnosed with ASD

Sponsors & Collaborators

• University of Southern California: lead
• Children's Hospital Los Angeles: collaborator

Related Publications (5)

• 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.

  PMID: 28268358 DERIVED

• 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.

  PMID: 25931290 DERIVED

• 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.

  PMID: 25871593 DERIVED

• 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.

  PMID: 25494494 DERIVED

• 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.

  PMID: 25114916 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sharon A Cermak, EdD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 4, 2014

Record last verified: 2014-02