Dental Fear Among Children With Autism Spectrum Disorders

Completed · Not applicable

Conditions studied: Dental Fear

In brief

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.

Key facts

Study ID

NCT01784276

Run by

Boston Children's Hospital

People needed

80

Starts

2010-09-01

Expected to finish

2012-08-01

Last updated by the study team

2013-02-05

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Boston Children'S Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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