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NCT01784276 · ClinicalTrials.gov registry record · NA
Dental Fear Among Children With Autism Spectrum Disorders
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01784276: Completed NA study, sponsored by Boston Children's Hospital.
NCT01784276 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01784276, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- BEHAVIORAL Video
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-08 |
| Phase | NA |
What the finished NCT01784276 record still lists
NCT01784276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Video is the first listed.
NCT01784276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01784276 about?
NCT01784276 is a clinical study titled "Dental Fear Among Children With Autism Spectrum Disorders". 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...
What is the current status of trial NCT01784276?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2010-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01784276?
The interventions under investigation include: Video (BEHAVIORAL).
Who is sponsoring clinical trial NCT01784276?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01784276's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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