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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 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 80 participants.
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.
Interventions
- BEHAVIORAL Video
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01784276
The ClinicalTrials.gov registry entry for NCT01784276 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Video is the first listed.
NCT01784276 reports 0 study locations.
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.
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