Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT02003820
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2013-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
In this pilot study improvement of tooth brushing practices in children with Autism Spectrum Disorder between the ages of eight and twelve years old will be evaluated. Participants placed in two randomized groups will watch a Youtube format instructional video twice each day immediately before each brushing during the three-week intervention period.
The video intervention will teach participants to use the usual and customary hygiene skills. Participants will view a child in their age range demonstrating proper brushing using the Bass brushing technique. The video will also have written narration at the bottom of the screen delivering printed information using Social Story style prompts. The Social Story prompts will also be read aloud for auditory delivery of information. The video will be two to three minutes long.
Success of intervention will be determined using data collected at multiple times during the pilot. First, clinical exams will be completed before the intervention, half way through the intervention, and at the end of three weeks to evaluate how clean the patients oral cavity appears. Exams should take no more than twenty minutes in the dental chair. Second, Qualtrics emails will be sent to the patient's caregiver at 5:30 AM and 4:30 PM each day during intervention providing access to the instructional video. After opening the email and watching the video, there will be a simple "yes or no" survey question asking the caregiver if the video was watching before that brushing session. Finally, more in depth caregiver surveys will be completed at the end of each week during the intervention consisting of no more than fifteen questions. The surveys will evaluate the caregiver's perception of intervention success. At completion of the intervention the video will be made available to all participants via Youtube.com. One final survey will be sent to caregivers three weeks post intervention to determine if the video is still being used for hygiene reinforcement.
Multiple efforts for study control will be implemented. To control for the impact that watching a video twice a day may have Group 2 will watch a control video. Group 1 will watch a dental hygiene video. Clinical evaluators will also be blinded to prevent bias when evaluating the two groups clinically. One examiner will conduct initial exams. A second examiner will conduct all subsequent exams with no knowledge of what group each patient is assigned. Evaluators will be calibrated pre-study evaluating hygiene patients at the dental clinic.
All participants in this study will also be enrolled at Yale Child Study Center to measure the participants IQ using autism specific IQ testing methods.
The video intervention will teach participants to use the usual and customary hygiene skills. Participants will view a child in their age range demonstrating proper brushing using the Bass brushing technique. The video will also have written narration at the bottom of the screen delivering printed information using Social Story style prompts. The Social Story prompts will also be read aloud for auditory delivery of information. The video will be two to three minutes long.
Success of intervention will be determined using data collected at multiple times during the pilot. First, clinical exams will be completed before the intervention, half way through the intervention, and at the end of three weeks to evaluate how clean the patients oral cavity appears. Exams should take no more than twenty minutes in the dental chair. Second, Qualtrics emails will be sent to the patient's caregiver at 5:30 AM and 4:30 PM each day during intervention providing access to the instructional video. After opening the email and watching the video, there will be a simple "yes or no" survey question asking the caregiver if the video was watching before that brushing session. Finally, more in depth caregiver surveys will be completed at the end of each week during the intervention consisting of no more than fifteen questions. The surveys will evaluate the caregiver's perception of intervention success. At completion of the intervention the video will be made available to all participants via Youtube.com. One final survey will be sent to caregivers three weeks post intervention to determine if the video is still being used for hygiene reinforcement.
Multiple efforts for study control will be implemented. To control for the impact that watching a video twice a day may have Group 2 will watch a control video. Group 1 will watch a dental hygiene video. Clinical evaluators will also be blinded to prevent bias when evaluating the two groups clinically. One examiner will conduct initial exams. A second examiner will conduct all subsequent exams with no knowledge of what group each patient is assigned. Evaluators will be calibrated pre-study evaluating hygiene patients at the dental clinic.
All participants in this study will also be enrolled at Yale Child Study Center to measure the participants IQ using autism specific IQ testing methods.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: