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

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sensory Adapted Dental Environment
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring autism, electrodermal activity, cooperation, anxiety, distress, stress, oral care, sensory processing, behavior, occupational therapy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Regular Dental Environment

    Sensory Adapted Dental Environment

    Arm Description

    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.

    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).

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    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).
    Time
    The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.

    Full Information

    First Posted
    February 27, 2014
    Last Updated
    February 28, 2014
    Sponsor
    University of Southern California
    Collaborators
    Children's Hospital Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02077985
    Brief Title
    Sensory Adapted Dental Environment to Enhance Oral Care for Children With ASD
    Acronym
    SADE
    Official Title
    Sensory Adapted Dental Environment to Enhance Oral Care for Children With Autism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Southern California
    Collaborators
    Children's Hospital Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism
    Keywords
    autism, electrodermal activity, cooperation, anxiety, distress, stress, oral care, sensory processing, behavior, occupational therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Regular Dental Environment
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Sensory Adapted Dental Environment
    Arm Type
    Experimental
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sensory Adapted Dental Environment
    Intervention Description
    See study arm description.
    Primary Outcome Measure Information:
    Title
    Electrodermal activity (EDA)
    Description
    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).
    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.
    Secondary Outcome Measure Information:
    Title
    Children's Dental Behavioral Rating Scale (CDBRS)
    Description
    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.
    Time Frame
    Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded during first five minutes of dental prophylaxis.
    Title
    Number of hands used to restrain child
    Description
    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.
    Time Frame
    Recorded throughout the dental cleaning (approximately 10-45 minutes)
    Title
    Frankl Scale
    Description
    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.
    Time Frame
    Completed at the end of each dental cleaning (approximately 10-45 minutes)
    Title
    The Anxiety and Cooperation Scale (A & C Scale)
    Description
    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).
    Time Frame
    Completed at the end of each dental cleaning (approximately 10-45 minutes)
    Title
    Time
    Description
    The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.
    Time Frame
    Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sharon A Cermak, EdD
    Organizational Affiliation
    University of Southern California
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28268358
    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.
    Results Reference
    derived
    PubMed Identifier
    25931290
    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.
    Results Reference
    derived
    PubMed Identifier
    25871593
    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.
    Results Reference
    derived
    PubMed Identifier
    25494494
    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.
    Results Reference
    derived
    PubMed Identifier
    25114916
    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.
    Results Reference
    derived

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

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