Autism Spectrum DisorderNCT02003820
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder
A study testing video modeled social story in people with Autism Spectrum Disorder and Dental Caries, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder, Dental Caries
- What is being tested?
- video modeled social story
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with Autism Spectrum Disorder
- Access to internet and email at home
- Patient of record at Yale New Haven Hospital Pediatric Dental Clinic
Who cannot join
- Outside of specified age range
- No home access to email and internet
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital Pediatric Dental Center
New Haven, Connecticut, 06511
Yale Pediatric Dental Center Suite 403
New Haven, Connecticut, 06511
About this study
Official title: Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Dental Caries
- Being tested
- video modeled social story
- Keywords
- Autism, Dental Caries, Prevention, Oral Hygiene
- Medical subject headings
- Autism Spectrum Disorder, Dental Caries, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video modeled social storyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Behavioral: video modeled social story |
| Group 2 | Experimental | 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. Receives: Behavioral: video modeled social story |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Secondary outcomes (1)
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...
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Popple, Yale University
- Investigators
- Ben S Popple, DMD, Principal investigator, Yale Pediatric DentistryFred Shic, PhD, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003820
- Sponsor's protocol ID
- Pedidentalautism
- Status last verified
- Aug 2016
- First submitted
- 2 Dec 2013
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Friedlander AH, Yagiela JA, Paterno VI, Mahler ME. The neuropathology, medical management and dental implications of autism. J Am Dent Assoc. 2006 Nov;137(11):1517-27. doi: 10.14219/jada.archive.2006.0086.
PubMed 17082277Volkmar, F.W., L,, A Practical Guide to Autism: what every parent, family member, and teacher needs to know. 2009, Hoboken, NJ: John Wiley & Sons, Inc. 610.
Rice C, Schendel D, Cunniff C, Doernberg N. Public health monitoring of developmental disabilities with a focus on the autism spectrum disorders. Am J Med Genet C Semin Med Genet. 2004 Feb 15;125C(1):22-7. doi: 10.1002/ajmg.c.30006.
PubMed 14755430American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision (DSM-IVTR). 2000, Washington, DC: American Psychiatric Publishing.
Marshall J, Sheller B, Mancl L. Caries-risk assessment and caries status of children with autism. Pediatr Dent. 2010 Jan-Feb;32(1):69-75.
PubMed 20298657Jaber MA. Dental caries experience, oral health status and treatment needs of dental patients with autism. J Appl Oral Sci. 2011 May-Jun;19(3):212-7. doi: 10.1590/s1678-77572011000300006.
PubMed 21625735Klein U, Nowak AJ. Characteristics of patients with autistic disorder (AD) presenting for dental treatment: a survey and chart review. Spec Care Dentist. 1999 Sep-Oct;19(5):200-7. doi: 10.1111/j.1754-4505.1999.tb01386.x.
PubMed 10765886Affairs, C.o.C., Guidelines on Caries-risk Assessment and Management for Infants, Children, and Adolescents. American Academy of Pediatric Dentistry Reference Manual, 2013. 35(6): p. 118-125.
Capozza LE, Bimstein E. Preferences of parents of children with autism spectrum disorders concerning oral health and dental treatment. Pediatr Dent. 2012 Nov-Dec;34(7):480-4.
PubMed 23265165DeMattei R, Cuvo A, Maurizio S. Oral assessment of children with an autism spectrum disorder. J Dent Hyg. 2007 Summer;81(3):65. Epub 2007 Jul 1.
PubMed 17908421Rada RE. Controversial issues in treating the dental patient with autism. J Am Dent Assoc. 2010 Aug;141(8):947-53. doi: 10.14219/jada.archive.2010.0308.
PubMed 20675420Loo CY, Graham RM, Hughes CV. The caries experience and behavior of dental patients with autism spectrum disorder. J Am Dent Assoc. 2008 Nov;139(11):1518-24. doi: 10.14219/jada.archive.2008.0078.
PubMed 18978390Marshall J, Sheller B, Mancl L, Williams BJ. Parental attitudes regarding behavior guidance of dental patients with autism. Pediatr Dent. 2008 Sep-Oct;30(5):400-7.
PubMed 18942599Stein LI, Polido JC, Najera SO, Cermak SA. Oral care experiences and challenges in children with autism spectrum disorders. Pediatr Dent. 2012 Sep-Oct;34(5):387-91.
PubMed 23211914Weil TN, Inglehart MR. Three- to 21-year-old patients with autism spectrum disorders: parents' perceptions of severity of symptoms, oral health, and oral health-related behavior. Pediatr Dent. 2012 Nov-Dec;34(7):473-9.
PubMed 23265164
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism
- ClinicalTrials.gov ID
- NCT02003820
- Acronym / sponsor ID
- Pedidentalautism
- Conditions
- Autism Spectrum Disorder, Dental Caries
- Keywords
- Autism, Dental Caries, Prevention, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: video modeled social storyGroup 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 | Experimental | Behavioral: video modeled social storyGroup 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed with Autism Spectrum Disorder
- Access to internet and email at home
- Patient of record at Yale New Haven Hospital Pediatric Dental Clinic
Key exclusion criteria (2 listed)
- Outside of specified age range
- No home access to email and internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video modeled social storyPatient 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. | Behavioural | Group 1, Group 2 |
Primary outcome
Measure of video intervention use
Time frame: 3 weeks
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
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.
1 secondary outcome
Caregiver survey
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Background: PubMed 17082277Friedlander AH, Yagiela JA, Paterno VI, Mahler ME. The neuropathology, medical management and dental implications of autism. J Am Dent Assoc. 2006 Nov;137(11):1517-27. doi: 10.14219/jada.archive.2006.0086.
- BackgroundVolkmar, F.W., L,, A Practical Guide to Autism: what every parent, family member, and teacher needs to know. 2009, Hoboken, NJ: John Wiley & Sons, Inc. 610.
- Background: PubMed 14755430Rice C, Schendel D, Cunniff C, Doernberg N. Public health monitoring of developmental disabilities with a focus on the autism spectrum disorders. Am J Med Genet C Semin Med Genet. 2004 Feb 15;125C(1):22-7. doi: 10.1002/ajmg.c.30006.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision (DSM-IVTR). 2000, Washington, DC: American Psychiatric Publishing.
- Background: PubMed 20298657Marshall J, Sheller B, Mancl L. Caries-risk assessment and caries status of children with autism. Pediatr Dent. 2010 Jan-Feb;32(1):69-75.
- Background: PubMed 21625735Jaber MA. Dental caries experience, oral health status and treatment needs of dental patients with autism. J Appl Oral Sci. 2011 May-Jun;19(3):212-7. doi: 10.1590/s1678-77572011000300006.
- Background: PubMed 10765886Klein U, Nowak AJ. Characteristics of patients with autistic disorder (AD) presenting for dental treatment: a survey and chart review. Spec Care Dentist. 1999 Sep-Oct;19(5):200-7. doi: 10.1111/j.1754-4505.1999.tb01386.x.
- BackgroundAffairs, C.o.C., Guidelines on Caries-risk Assessment and Management for Infants, Children, and Adolescents. American Academy of Pediatric Dentistry Reference Manual, 2013. 35(6): p. 118-125.
- Background: PubMed 23265165Capozza LE, Bimstein E. Preferences of parents of children with autism spectrum disorders concerning oral health and dental treatment. Pediatr Dent. 2012 Nov-Dec;34(7):480-4.
- Background: PubMed 17908421DeMattei R, Cuvo A, Maurizio S. Oral assessment of children with an autism spectrum disorder. J Dent Hyg. 2007 Summer;81(3):65. Epub 2007 Jul 1.
- Background: PubMed 20675420Rada RE. Controversial issues in treating the dental patient with autism. J Am Dent Assoc. 2010 Aug;141(8):947-53. doi: 10.14219/jada.archive.2010.0308.
- Background: PubMed 18978390Loo CY, Graham RM, Hughes CV. The caries experience and behavior of dental patients with autism spectrum disorder. J Am Dent Assoc. 2008 Nov;139(11):1518-24. doi: 10.14219/jada.archive.2008.0078.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben S Popple, DMD principal investigator
Yale Pediatric Dentistry
Fred Shic, PhD study chair
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video modeled social story in people with Autism Spectrum Disorder and Dental Caries, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of video intervention use (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003820, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.