Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-29 @ 4:19 PM
Study NCT ID:
NCT02003820
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D003731', 'term': 'Dental Caries'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-05', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-02', 'lastUpdatePostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of video intervention use', 'timeFrame': '3 weeks', '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.'}, {'measure': 'Plaque index', 'timeFrame': '3 weeks', '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.'}], 'secondaryOutcomes': [{'measure': 'Caregiver survey', 'timeFrame': '6 weeks', '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..."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autism', 'Dental Caries', 'Prevention', 'Oral Hygiene'], 'conditions': ['Autism Spectrum Disorder', 'Dental Caries']}, 'referencesModule': {'references': [{'pmid': '17082277', 'type': 'BACKGROUND', '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. doi: 10.14219/jada.archive.2006.0086.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '14755430', 'type': 'BACKGROUND', '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. doi: 10.1002/ajmg.c.30006.'}, {'type': 'BACKGROUND', 'citation': 'American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Text Revision (DSM-IVTR). 2000, Washington, DC: American Psychiatric Publishing.'}, {'pmid': '20298657', 'type': 'BACKGROUND', '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.'}, {'pmid': '21625735', 'type': 'BACKGROUND', '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. doi: 10.1590/s1678-77572011000300006.'}, {'pmid': '10765886', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1754-4505.1999.tb01386.x.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23265165', 'type': 'BACKGROUND', '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.'}, {'pmid': '17908421', 'type': 'BACKGROUND', '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.'}, {'pmid': '20675420', 'type': 'BACKGROUND', 'citation': 'Rada 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.'}, {'pmid': '18978390', 'type': 'BACKGROUND', '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. doi: 10.14219/jada.archive.2008.0078.'}, {'pmid': '18942599', 'type': 'BACKGROUND', '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.'}, {'pmid': '23211914', 'type': 'BACKGROUND', '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.'}, {'pmid': '23265164', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '24002415', 'type': 'BACKGROUND', 'citation': 'Orellana LM, Martinez-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.'}, {'pmid': '20697791', 'type': 'BACKGROUND', '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.'}, {'pmid': '2793634', 'type': 'BACKGROUND', 'citation': 'Charlop MH, Milstein JP. Teaching autistic children conversational speech using video modeling. J Appl Behav Anal. 1989 Fall;22(3):275-85. doi: 10.1901/jaba.1989.22-275.'}, {'pmid': '22284800', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22937239', 'type': 'BACKGROUND', '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.'}, {'pmid': '20923896', 'type': 'BACKGROUND', '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.'}, {'pmid': '20054628', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Ali, S.F., N., Investigating the Evidence Base of Social Stories. Educational Psycology in Practice, 2006. 22(4): p. 355-377.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nSuccess 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.\n\nMultiple 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.\n\nAll participants in this study will also be enrolled at Yale Child Study Center to measure the participants IQ using autism specific IQ testing methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Autism Spectrum Disorder\n* Access to internet and email at home\n* Patient of record at Yale New Haven Hospital Pediatric Dental Clinic\n\nExclusion Criteria:\n\n* Outside of specified age range\n* No home access to email and internet'}, 'identificationModule': {'nctId': 'NCT02003820', 'briefTitle': 'Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Using Video Modeled Social Stories to Improve Oral Hygiene in Children With Autism', 'orgStudyIdInfo': {'id': 'Pedidentalautism'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', '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.', 'interventionNames': ['Behavioral: video modeled social story']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', '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.', 'interventionNames': ['Behavioral: video modeled social story']}], 'interventions': [{'name': 'video modeled social story', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital Pediatric Dental Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Pediatric Dental Center Suite 403', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Ben S Popple, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale Pediatric Dentistry'}, {'name': 'Fred Shic, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Ben Popple', 'investigatorAffiliation': 'Yale University'}}}}