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Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder, Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video modeled social story
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autism Spectrum Disorder focused on measuring Autism, Dental Caries, Prevention, Oral Hygiene

Eligibility Criteria

5 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital Pediatric Dental Center
  • Yale Pediatric Dental Center Suite 403

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Group 1 will receive plaque index exam and immediately start their three week intervention of watching a dental hygiene video immediately before brushing twice per day. Plaque index exams will be completed at start, t-10 days, and t-21 days. Parental surveys will be completed at each plaque index exam and 6 weeks after start.

Group 2 will receive plaque index exam and immediately start their three week intervention of watching a control video immediately before brushing twice per day. Plaque index exams will be completed at start, t-10 days, and t-21 days. Parental surveys will be completed at each plaque index exam and 6 weeks after start.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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...

Full Information

First Posted
December 2, 2013
Last Updated
August 5, 2016
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02003820
Brief Title
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder
Official Title
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Dental Caries
Keywords
Autism, Dental Caries, Prevention, Oral Hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 will receive plaque index exam and immediately start their three week intervention of watching a dental hygiene video immediately before brushing twice per day. Plaque index exams will be completed at start, t-10 days, and t-21 days. Parental surveys will be completed at each plaque index exam and 6 weeks after start.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2 will receive plaque index exam and immediately start their three week intervention of watching a control video immediately before brushing twice per day. Plaque index exams will be completed at start, t-10 days, and t-21 days. Parental surveys will be completed at each plaque index exam and 6 weeks after start.
Intervention Type
Behavioral
Intervention Name(s)
video modeled social story
Intervention Description
Patient will watch a Youtube compatible video of a child in the same age range as the study participants demonstrating proper brushing technique. The video will be paired with written subtitles created using the Social Story format. The subtitles will be read to the participant as the video plays. The patient will watch the video immediately before each brushing session morning and night for the three week intervention. After the intervention period the video will be made available on Youtube.com for the participants to use as they wish.
Primary Outcome Measure Information:
Title
Measure of video intervention use
Description
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.
Time Frame
3 weeks
Title
Plaque index
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Caregiver survey
Description
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...
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben S Popple, DMD
Organizational Affiliation
Yale Pediatric Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Shic, PhD
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
Yale New Haven Hospital Pediatric Dental Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale Pediatric Dental Center Suite 403
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

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Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder

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