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Dental Fear Among Children With Autism Spectrum Disorders

NCT01784276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-02-05

No results posted yet for this study

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.

Conditions

  • Dental Fear

Interventions

BEHAVIORAL

Video

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.

Sponsors & Collaborators

Principal Investigators

  • INYANG ISONG, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784276 on ClinicalTrials.gov