Dental Fear Among Children With Autism Spectrum Disorders

Recruiting in Palo Alto (17 mi)

Overseen byINYANG ISONG, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boston Children's Hospital

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

INYANG ISONG, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

subjects aged 7-17 years with a known diagnosis of autism, who had a history of dental fear, per parental report.

Treatment Details

Interventions

Video (Behavioural Intervention)

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Video peer modeling plus video gogglesExperimental Treatment1 Intervention

Video 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.

Group II: Video peer modelingExperimental Treatment1 Intervention

Video peer modeling (at home, the child watched a DVD recording of a typically developing child undergoing a dental visit);

Group III: Video goggles or portable DVD onlyExperimental Treatment1 Intervention

Video goggles/DVD (during the dental visit, the child watched their favorite movie using sunglass style video eyewear, or portable DVD player);

Group IV: ControlActive Control1 Intervention

Children assigned to Group A (control group) received usual care and therefore had no intervention before or during the return visit.

Video is already approved in Canada for the following indications: