Dental Fear Among Children With Autism Spectrum Disorders
Condition: Dental Fear
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Specific Aims Our study objective is to investigate if video peer modeling before the visit,
      plus immersive virtual reality during a preventive dental visit, reduces dental fear and
      uncooperative behaviors among children with ASD.

      SPECIFIC AIM: To pilot and test the feasibility and effectiveness of video peer modeling and
      immersive virtual reality in reducing dental fear among children with autism undergoing
      preventive dental visits.

      Methods: The investigators will enroll eighty (80) subjects aged 7-17 years with a known
      diagnosis of autism, who had a history of dental fear, per parental report.

      Study hypotheses:

      The primary hypotheses of interest are:

      (i) The mean change in the Venham Anxiety Score (VAS) over the 4 month period in children
      with ASD who receive the video intervention (Group B) is different from the mean change in
      the VAS over the 4-month period in children with ASD in the control group.

      (ii) The mean change in the VAS over the 4-month period in children with ASD who receive the
      immersive VR intervention (Group C) is different from the mean change in the VAS over the
      4-month period in children with ASD in the control group.

      (iii) The mean change in the VAS over the 4-month period in children with ASD who receive the
      video intervention plus the immersive VR intervention (Group D) is different from the mean
      change in the VAS over the 4-month period in children with ASD in the control group.

      The secondary hypothesis is:

      (i) The mean change in the Venham Behavior Score over the 4-month period in children with ASD
      in Group D is different from the mean change in the Venham Behavior Score over the 4-month
      period in children with ASD in Group B or C.
    

Detailed description: 
      Dental care is a significant unmet health care need for children with Autism Spectrum
      Disorders (ASD). Many children with ASD do not receive dental care because of fear associated
      with dental procedures; oftentimes they require general anesthesia for regular dental
      procedures, placing them at risk of associated complications. Many children with ASD have a
      strong preference for visual stimuli, particularly electronic screen media; this affinity has
      been utilized in their educational instruction.

      Objective: To determine if an innovative strategy using two types of electronic screen media
      was feasible and beneficial in reducing fear and uncooperative behaviors in children with ASD
      undergoing dental visits.

      Study procedures

      For this randomized control study, we will randomize participants into one of 4 groups: a)
      control group (Group A); b) video peer modeling only group (Group B); c) immersive VR only
      group (Group C) and d) video peer modeling plus immersive VR group (Group D). All enrolled
      children will have a pre-visit in the dental clinic, where they will receive usual care and
      baseline values of all parameters will be obtained. Medical records of all study children
      will be flagged so that they are identified upon arrival by the RA. In the exam room, the
      dental assistant will measure their pulse rate using a pulse oximeter. The dentist and RA
      will complete the Venham Anxiety and Behavioral Scale during the dental procedure for all
      study children. All study subjects will be scheduled to return for a follow up preventive
      dental visit in 4-6 months, which is the usual practice at CHB, depending on the child's oral
      health status. Children assigned to intervention Groups B and D will be mailed a copy of a
      DVD of the pre-recorded peer modeled visit 4 weeks before the scheduled return for the
      preventive dental visit. The parents will be asked to review the video with their child to
      orient them to all stages of the dental visit. In addition, children assigned to Group C and
      D will be given a virtual reality headset to watch movies or images during the dental visit.
      Children assigned to Group A (control group) will receive neither the DVD nor VR headset
      during the visit. We will repeat all measurements during the return visit for all study
      children.

      Participant randomization: Once we identify the entire sample of eligible subjects, we will
      generate a list of subjects that have enrolled for the study. With the assistance of the
      statistician, we will do a random allocation of each subject to Group A, B, C or D.

      Sample size calculation:

      In order to have an 80% chance of detecting a difference of 1 unit in either the mean change
      in the Venham anxiety score (VAS) over the 4-month period in children with ASD assigned to
      Group B, C or D, with the mean change in the VAS over the 4-month period in children with ASD
      in Group A, allowing for a 20% dropout rate, a total sample size of 80 children will be
      required. Subjects are being allocated equally between the 4 groups and each group will be
      randomly assigned 20 subjects. Data Analyses: After obtaining values of the Venham Anxiety
      and Behavior Scores for each group at baseline and 4 month period, the change in score will
      be calculated for each subject and a mean change in score and standard deviation generated
      for each group. WE will use a two-sided t-test to test each of these hypotheses. Bonferroni
      adjustments will be used to account for the multiple comparisons being carried out. The
      association of important covariates, such as the level of cognitive functioning, IQ, age,
      gender and number of hours of ABA received with the change in VAS will be modeled using
      linear regression analyses, with the outcome variable being the mean change in score for each
      subject. (A separate model will be fit for each outcome variable). Further analyses will
      include examining the association of pulse rate (a continuous outcome measure) with the
      covariates listed above. All analyses will be conducted by the study statistician and PI.

      Data Management Methods The RA will collect and manage all study data. We will enter personal
      information of study subjects obtained at enrollment in the study database. All subjects will
      be assigned codes which will be used throughout the study. No subject identifying personal
      information will be used to make up the study code for a specific patient. The link between
      the study-ID and medical record number will be kept in a locked/double password protected
      file. The Dr Isong and the RA will be the only ones who know the key/passwords.

      Data and Safety Monitoring Plan Every 6 months, all study data and protocols will be reviewed
      by the RA and PI to ensure that they confirm to written stipulations. Any missing data will
      be noted and collected.

      To prevent disclosure, information about participation and the results of the research will
      not be placed in the medical record. Study data will be coded and the key to the code kept in
      a separate locked file. All research data will be entered into a database. No names are
      entered into this database, only the codes assigned to the research record. All results will
      remain confidential. Only anonymized data will be shared among collaborators.

      Safety monitoring Risks associated with this study are expected to be minimal. Any report of
      risk or discomfort as a result of the study (please see below) experienced by study subjects
      will be documented and appropriate treatment and referrals will be provided. Subjects will be
      informed that they can dis-enroll from the study at any time if they experience any adverse
      effects.
    

Intervention name(s): Video
Intervention type(s): Behavioral
Intervention description(s): Video peer modeling: The video demonstrates various stages of the dental visit experience. Children assigned to intervention Groups B or D reviewed the video at least once, but as many times as possible before the follow up visit.
Video goggles: This is a sunglass style video eyewear that contains two computer screens that can be used to watch 2 or 3D movies. Subjects randomized to Group C or D watched a 2D movie during the return visit, using the video goggles. Subjects who refused or were unable to wear the goggles watched the movie using a hand held portable DVD player.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Children; Autism Spectrum Disorders; Electronic Screen Media; Dental fear