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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Yale University
Sponsor:
Information provided by (Responsible Party):
Ben Popple, Yale University
ClinicalTrials.gov Identifier:
NCT02003820
First received: December 2, 2013
Last updated: July 21, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention
Autism Spectrum Disorder
Dental Caries
Behavioral: video modeled social story

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Measure of video intervention use [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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...


Estimated Enrollment: 40
Study Start Date: July 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
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.
Behavioral: video modeled social story
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.
Experimental: Group 2
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.
Behavioral: video modeled social story
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003820

Contacts
Contact: Ben S Popple, DMD 203-688-3000 ben.popple@ynhh.org
Contact: Keri Discepolo, DDS 203-688-3000 keri.discepolo@ynhh.org

Locations
United States, Connecticut
Yale Pediatric Dental Center Suite 403 Enrolling by invitation
New Haven, Connecticut, United States, 06511
Yale New Haven Hospital Pediatric Dental Center Recruiting
New Haven, Connecticut, United States, 06511
Contact: Ben S Popple, DMD    203-688-3000    ben.popple@ynhh.org   
Principal Investigator: Ben S Popple, DMD         
Sub-Investigator: Keri Discepolo, DDS         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Ben S Popple, DMD Yale Pediatric Dentistry
Study Chair: Fred Shic, PhD Yale University
  More Information

Publications:

Responsible Party: Ben Popple, Resident, Yale University
ClinicalTrials.gov Identifier: NCT02003820     History of Changes
Other Study ID Numbers: Pedidentalautism
Study First Received: December 2, 2013
Last Updated: July 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Autism
Dental Caries
Prevention
Oral Hygiene

Additional relevant MeSH terms:
Autistic Disorder
Dental Caries
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 27, 2014