Autism Spectrum Disorder Clinical Trial
Official title:
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism
| Verified date | August 2016 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
We hypothesize that oral hygiene habits in children 8-12 years of age can be improved using video format Social Story intervention techniques. The purpose of this study is to investigate the effectiveness of video format social stories used to inform and educate children and parents about proper dental hygiene technique over a 6 week intervention period. We will measure the success of intervention using data collected from clinical exams and caregiver/participant surveys. Evaluation of data collected will be used to determine the effectiveness of the intervention.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 14 Years |
| Eligibility |
Inclusion Criteria: - Diagnosed with Autism Spectrum Disorder - Access to internet and email at home - Patient of record at Yale New Haven Hospital Pediatric Dental Clinic Exclusion Criteria: - Outside of specified age range - No home access to email and internet |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale New Haven Hospital Pediatric Dental Center | New Haven | Connecticut |
| United States | Yale Pediatric Dental Center Suite 403 | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University |
United States,
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* Note: There are 23 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure of video intervention use | Video intervention will be emailed to participants twice daily during intervention period. After watching video the patient will be given a one question survey asking if they watched the video before that brushing period. | 3 weeks | No |
| Primary | Plaque index | Patients will be given a usual and customary dental exam in the clinic before intervention is introduced to evaluate level of oral hygiene by a blinded evaluator. Plaque index will also be measured in the usual and customary manor half way through intervention and at the end of intervention period. | 3 weeks | No |
| Secondary | Caregiver survey | Caregivers will be given 10-15 question surveys at beginning of intervention, at the each week clinical visit during the intervention, and 3 weeks post intervention measuring their perception of the intervention's effect on the study subject. Questions will measure ease of completing brushing, perceived brushing effectiveness, amount of help patient requires to brush effectively, interest in video... | 6 weeks | No |
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