Dental Fear Among Children With Autism Spectrum Disorders
A PILOT AND FEASIBILITY STUDY OF ELECTRONIC SCREEN MEDIA TO REDUCE DENTAL FEAR AMONG CHILDREN WITH AUTISM SPECTRUM DISORDER
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedFebruary 5, 2013
February 1, 2013
1.9 years
January 31, 2013
February 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety
Primary outcome: Anxiety: To assess the subject's level of anxiety, we will use the Venham Anxiety Rating Scale which assigns numerical values to the child's observable behaviors. It consists of 5 behaviorally defined categories that range from 0-5, and higher scores indicate greater levels of anxiety.(ref) The treating dentist and RA will use the Venham Scale to indicate their perception of level of anxiety experienced by the participant during the dental procedure.
6 month
Secondary Outcomes (1)
Uncooperative behavior
6 month
Other Outcomes (1)
Pulse rate
6 months
Study Arms (4)
Control
NO INTERVENTIONChildren assigned to Group A (control group) received usual care and therefore had no intervention before or during the return visit.
Video peer modeling
EXPERIMENTALVideo peer modeling (at home, the child watched a DVD recording of a typically developing child undergoing a dental visit);
Video goggles or portable DVD only
EXPERIMENTALVideo goggles/DVD (during the dental visit, the child watched their favorite movie using sunglass style video eyewear, or portable DVD player);
Video peer modeling plus video goggles
EXPERIMENTALVideo peer modeling plus video goggles/DVD. At home, the child watched a DVD recording of a typically developing child undergoing a dental visit; During the dental visit, the child watched their favorite movie using sunglass style video eyewear, or portable DVD player.
Interventions
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.
Eligibility Criteria
You may qualify if:
- subjects aged 7-17 years with a known diagnosis of autism, who had a history of dental fear, per parental report.
You may not qualify if:
- children with motor handicaps (e.g. cerebral palsy), and sensory, vision and hearing impairments (as these would have limited their ability to utilize intervention materials);
- children with parents who did not speak English or Spanish; and
- children who presented to clinic without their legal guardian.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children'S Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
INYANG ISONG, MD
Boston Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 5, 2013
Study Start
September 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 5, 2013
Record last verified: 2013-02