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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02003820
Other study ID # Pedidentalautism
Secondary ID
Status Completed
Phase N/A
First received December 2, 2013
Last updated August 5, 2016
Start date July 2014
Est. completion date July 2015

Study information

Verified date August 2016
Source Yale University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (23)

Affairs, 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.

Ali, S.F., N., Investigating the Evidence Base of Social Stories. Educational Psycology in Practice, 2006. 22(4): p. 355-377.

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision (DSM-IVTR). 2000, Washington, DC: American Psychiatric Publishing.

Bohlander AJ, Orlich F, Varley CK. Social skills training for children with autism. Pediatr Clin North Am. 2012 Feb;59(1):165-74, xii. doi: 10.1016/j.pcl.2011.10.001. Review. — View Citation

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. — View Citation

Cardon TA, Wilcox MJ. Promoting imitation in young children with autism: a comparison of reciprocal imitation training and video modeling. J Autism Dev Disord. 2011 May;41(5):654-66. doi: 10.1007/s10803-010-1086-8. — View Citation

Charlop MH, Milstein JP. Teaching autistic children conversational speech using video modeling. J Appl Behav Anal. 1989 Fall;22(3):275-85. — View Citation

DeMattei 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. — View Citation

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. Review. — View Citation

Jaber 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. — View Citation

Karkhaneh M, Clark B, Ospina MB, Seida JC, Smith V, Hartling L. Social Stories ™ to improve social skills in children with autism spectrum disorder: a systematic review. Autism. 2010 Nov;14(6):641-62. doi: 10.1177/1362361310373057. Epub 2010 Oct 5. Review. — View Citation

Klein 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. — View Citation

Kokina A, Kern L. Social Story interventions for students with autism spectrum disorders: a meta-analysis. J Autism Dev Disord. 2010 Jul;40(7):812-26. doi: 10.1007/s10803-009-0931-0. — View Citation

Litras S, Moore DW, Anderson A. Using video self-modelled social stories to teach social skills to a young child with autism. Autism Res Treat. 2010;2010:834979. doi: 10.1155/2010/834979. Epub 2010 Jun 9. — View Citation

Loo 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. — View Citation

Marshall 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. — View Citation

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. — View Citation

Orellana LM, Martínez-Sanchis S, Silvestre FJ. Training adults and children with an autism spectrum disorder to be compliant with a clinical dental assessment using a TEACCH-based approach. J Autism Dev Disord. 2014 Apr;44(4):776-85. doi: 10.1007/s10803-013-1930-8. — View Citation

Rada RE. Controversial issues in treating the dental patient with autism. J Am Dent Assoc. 2010 Aug;141(8):947-53. Review. — View Citation

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. Review. — View Citation

Stein 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. — View Citation

Volkmar, 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.

Weil 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. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

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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