Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT02430051
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sensory Adapted Dental Environments to Enhance Oral Care for Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lstein@chan.usc.edu', 'phone': '(323)442-0371', 'title': 'Dr. Leah Stein Duker', 'organization': 'University of Southern California'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': "Adverse event data was collected for any reportable events throughout study completion. The duration of each participant's study participation was approximately 1 year.", 'description': 'There were no occurrences of Serious Adverse Events, All-Cause Mortalities, or Other (Not Including Serious) Adverse Events throughout the duration of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Electrodermal Activity (EDA) - Skin Conductance Level (SCL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.96', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '7.74', 'spread': '4.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed-effects regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for attained age and first or second clinic visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.', 'description': 'Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.', 'unitOfMeasure': 'microsiemens (µS)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 248 analyzable observations for EDA SCLs.'}, {'type': 'PRIMARY', 'title': 'Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.25', 'spread': '3.03', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed-effects regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjustment for attained age and first and second clinic visit.'}], 'paramType': 'MEAN', 'timeFrame': 'Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.', 'description': 'Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. Each unique increase \\>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).', 'unitOfMeasure': 'number of NS-SCRs per minute (frequency)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 245 analyzable observations for EDA NS-SCRs.'}, {'type': 'SECONDARY', 'title': "Children's Dental Behavior Rating Scale (CDBRS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.41', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '46.10', 'spread': '10.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'The CDBRS is a video-coded measure of overt distress behaviors exhibited by children during a routine dental visit. A research team member marks the presence or absence of three distress behaviors (mouth movement, head movement, forehead movement) and the presence or absence and the severity of two distress behaviors (whimper/cry/scream, verbal stall or delay) during each one-minute interval of a five-minute recording of a child receiving prophylaxis during their dental cleaning. Coding is conducted by a trained research team member who achieves strong inter-rater reliability with a second trained rater on a representative sample of children with and without ASD. Raw scores (range=0-45) are converted to a scale score ranging from 1 to 100, with higher scores indicating greater distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for CDBRS.'}, {'type': 'SECONDARY', 'title': 'Whimper, Cry, Scream Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.26', 'spread': '68.39', 'groupId': 'OG000'}, {'value': '19.70', 'spread': '43.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Duration of whimpers, cries, or screams, as scored by video coding.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for whimper, cry, scream duration.'}, {'type': 'SECONDARY', 'title': 'Whimper, Cry, Scream Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.83', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '7.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of whimpers, cries, or screams, as scored by video coding.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for whimper, cry, scream frequency.'}, {'type': 'SECONDARY', 'title': 'Mouth Movement Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.43', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '4.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of mouth movement impeding treatment, as scored by video coding.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for mouth movement frequency.'}, {'type': 'SECONDARY', 'title': 'Head Movement Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.36', 'spread': '19.39', 'groupId': 'OG000'}, {'value': '11.68', 'spread': '13.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding.', 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 analyzable observations for head movement frequency.'}, {'type': 'SECONDARY', 'title': 'Faces Pain Scale - Revised', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.37', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '3.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1-2 minutes)', 'description': 'The Faces Pain Scale - Revised is single-item self-report measure used to assess the perception and intensity of pain in children. The scale is comprised of six faces depicting increasing levels of pain ranging from a neutral expression (no pain) to a face showing severe pain. Each face corresponds to a numerical value on a 0-10 scale (0, 2, 4, 6, 8, 10). Higher scores indicate greater perception and intensity of pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 114 usable scores for the Faces Pain Scale-Revised.'}, {'type': 'SECONDARY', 'title': 'Dental Sensory Sensitivity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.68', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 3 minutes)', 'description': 'The Dental Sensory Sensitivity Scale is a child-report measure assessing the presence and magnitude of discomfort with different sensory stimuli in the dental environment (i.e., tactile, auditory, proprioceptive). The scale is comprised of 6 items rated on a 3-point Likert scale ranging from 0 (not at all) to 2 (a lot). Scores range from 0 - 12 with higher scores indicating greater sensory discomfort during routine dental treatment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 106 usable scores for the Dental Sensory Sensitivity Scale.'}, {'type': 'SECONDARY', 'title': 'Anxiety and Cooperation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, and tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '1.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1 minute)', 'description': "The Anxiety and Cooperation Scale (A \\& C Scale) has been shown to assess children's anxiety, fear, and cooperation as rated by dentists, and has good established reliability and validity. Following a routine dental cleaning, the dentist rated overall patient behavior during treatment using a one-item Likert scale ranging from 0 (relaxed, smiling, demonstrates desired behavior, complies with demands) to 5 (out of control, loud crying, reverts to primitive flight responses, physical restraint required).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 usable scores for the Anxiety and Cooperation Scale.'}, {'type': 'SECONDARY', 'title': 'Frankl Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.61', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1 minute)', 'description': "The Frankl Scale is dentist-report measure of a child's overall behavior during a dental visit. It is an observational, single-item measure that includes four behavioral categories, each assigned a numerical value (1=definitely negative, 2=negative, 3=positive, 4=definitely positive). Higher scores indicate greater cooperation and less distress.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 276 usable scores for Frankl Scale.'}, {'type': 'SECONDARY', 'title': 'Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.51', 'spread': '3.86', 'groupId': 'OG000'}, {'value': '10.20', 'spread': '4.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Multivariate linear regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for autism severity, IQ, dental fear and anxiety, sensory over-responsivity, general anxiety, expressive communication, gender, and age.'}], 'paramType': 'MEAN', 'timeFrame': 'Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit', 'description': 'The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 252 analyzable durations.'}, {'type': 'SECONDARY', 'title': 'Number of Hands Used to Restrain Child', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment, no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'id': 'OG001', 'title': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations).\n\nSensory Adapted Dental Environment: The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.14', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '2.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'General linear mixed model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Recorded throughout the dental cleaning (approximately 10-45 minutes)', 'description': 'The maximum number of hands (at any one time) required to restrain the child during the dental cleaning experience was utilized as a measure of cost and also a measure of uncooperative behavior. This variable was recorded on researcher notes during the dental cleaning and was verified using the videotape of the dental cleaning. Scoring included presence/absence as well as the number of hands used for restraint purposes during the cleaning.', 'unitOfMeasure': 'hands', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'As this was a crossover study, all participants received cleanings in both the RDE and SADE conditions. Of the 162 participants, there were 302 analyzable data points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regular Dental Environment First, Then Sensory Adapted Dental Environment', 'description': 'Dental Visit #1 (Day 5-95):\n\nParticipants received their first dental cleaning in the Regular Dental Environment (RDE). In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).\n\nDental Visit #2 (Day 125-215):\n\nParticipants received their second dental cleaning in the Sensory Adapted Dental Environment (SADE) approximately 6 months after their first dental cleaning. In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.'}, {'id': 'FG001', 'title': 'Sensory Adapted Dental Environment First, Then Regular Dental Environment', 'description': 'Dental Visit #1 (Day 5-95):\n\nParticipants received their first dental cleaning in the Sensory Adapted Dental Environment (SADE). In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.\n\nDental Visit #2 (Day 125-215):\n\nParticipants received their second dental cleaning in the Regular Dental Environment (RDE) approximately 6 months after their first dental cleaning. In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'Second Dental Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Dropped due to not meeting scheduling requirements', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from health clinics (eg, CHLA dental clinic), community service providers (eg, developmental disability service providers, resource fairs), therapy and behavioral clinics, patient referrals, parent support groups, social media, and the Los Angeles Unified School District.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Regular Dental Environment First, Then Sensory Adapted Dental Environment', 'description': 'Dental Visit #1 (Day 5-95) Participants received their first dental cleaning in the Regular Dental Environment (RDE). In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).\n\nDental Visit #2 (Day 125-215) Participants received their second dental cleaning in the Sensory Adapted Dental Environment (SADE) approximately 6 months after their first dental cleaning. In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.'}, {'id': 'BG001', 'title': 'Sensory Adapted Dental Environment First, Then Regular Dental Environment', 'description': 'Dental Visit #1 (Day 5-95) Participants received their first dental cleaning in the Sensory Adapted Dental Environment (SADE). In the SADE, the sensory characteristics of the dental environment are altered (visual, auditory, tactile adaptations) including dimming lighting, moving projections on the ceiling, exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide a calming sensation.\n\nDental Visit #2 (Day 125-215) Participants received their second dental cleaning in the Regular Dental Environment (RDE) approximately 6 months after their first dental cleaning. In this condition, no sensory characteristics of the dental environment are altered and the cleaning is conducted in a standard manner (oral examination, prophylaxis, fluoride).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.19', 'spread': '2.04', 'groupId': 'BG000'}, {'value': '9.33', 'spread': '1.93', 'groupId': 'BG001'}, {'value': '9.26', 'spread': '1.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Autism Diagnostic Observation Schedule-2 (ADOS-2) Severity Score', 'classes': [{'categories': [{'measurements': [{'value': '6.19', 'spread': '1.78', 'groupId': 'BG000'}, {'value': '6.65', 'spread': '1.89', 'groupId': 'BG001'}, {'value': '6.41', 'spread': '1.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The ADOS-2 is a semi-structured, standardized performance-based observational assessment of social affect, communication, reciprocal social interaction, restricted and repetitive behaviors, imagination/creativity, stereotyped behaviors, and restricted interests. The severity (comparison) score is used as a standardized measure of autism symptom severity, independent of age and language level. The score ranges from 1 to 10, with higher scores indicating greater severity of autism-related symptoms (i.e., 3-4: low, 5-7: moderate, 8-10: high).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wechsler Abbreviated Scale of Intelligence (WASI-II) Full Scale Intelligence Quotient (FSIQ4)', 'classes': [{'categories': [{'measurements': [{'value': '74.71', 'spread': '23.14', 'groupId': 'BG000'}, {'value': '71.56', 'spread': '24.40', 'groupId': 'BG001'}, {'value': '73.16', 'spread': '23.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The WASI-II is a reliable and valid standardized measure of cognitive ability. The FSIQ-4 is derived from four subtests (Vocabulary, Similarities, Block Design, and Matrix Reasoning). The FSIQ-4 is calculated by summing the scaled scores from all four subtests and converting the total into a standard score using age-based normative data. The FSIQ-4 standard score ranges from 40 to 160. Higher scores represent better cognitive functioning and a score of \\<70 is used to determine intellectual disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Vineland Adaptive Behavior Scales (VABS-II) Expressive Communication', 'classes': [{'categories': [{'measurements': [{'value': '64.97', 'spread': '29.15', 'groupId': 'BG000'}, {'value': '63.63', 'spread': '27.29', 'groupId': 'BG001'}, {'value': '64.31', 'spread': '28.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The VABS-II is a reliable and valid parent-report assessment of receptive, expressive, and written communication skills in individuals aged 3 to 22. Each item is scored as 0 (never), 1 (sometimes/partially), or 2 (usually), and these item scores are summed to produce a raw score, ranging from 0 to 108, then converted to a scale score using age-specific data. The Expressive Communication subdomain yields a v-scale score ranging from 1 to 24. Higher scale scores indicate better expressive communication skills and a raw score of 83 is equivalent to the expressive language of a four-year-old.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sensory Over-Responsitivty (SensOR) Inventory Total', 'classes': [{'categories': [{'measurements': [{'value': '25.36', 'spread': '12.95', 'groupId': 'BG000'}, {'value': '29.46', 'spread': '13.91', 'groupId': 'BG001'}, {'value': '27.38', 'spread': '13.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The SensOR Inventory is a 76-item caregiver-report measure of sensory processing patterns and sensitivities in individuals ages 3 or older. Items are scored with dichotomous yes/no responses. The scale consists of six domains (i.e., tactile, auditory, visual, olfactory, food texture, and movement-proprioceptive) that are summed for a total score. Scores range from 0-76 with higher scores indicate greater sensory over-responsiveness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Child and Adolescent Symptom Inventory-4 Autism Anxiety Scale (CASI-Anx)', 'classes': [{'categories': [{'measurements': [{'value': '18.55', 'spread': '9.91', 'groupId': 'BG000'}, {'value': '21.39', 'spread': '10.47', 'groupId': 'BG001'}, {'value': '19.95', 'spread': '10.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CASI-Anx is a 20-item parent-report measure of anxiety in children with autism. Items are scored on a four-point Likert scale (i.e., 0-never, 1-sometimes, 2-often, 3-very often). The total score is calculated by taking the sum of the responses to all items. Scores range from 0 - 60 with higher scores indicating greater anxiety symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Children's Fear Survey Schedule - Dental Subscale (CFSS-DS)", 'classes': [{'categories': [{'measurements': [{'value': '45.94', 'spread': '14.92', 'groupId': 'BG000'}, {'value': '49.25', 'spread': '12.10', 'groupId': 'BG001'}, {'value': '47.57', 'spread': '13.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CFSS-DS is a reliable and valid measure of dental fear in children. It is a 15-item, parent-report measure scored on a 5-point Likert scale (i.e., 1-not afraid at all to 5-very afraid). The total score is calculated by taking the sum of the responses to all items. Scores range from 15 -75 with higher scores indicating greater dental fear. Scores of 32-38 indicate borderline fear and those \\>38 suggest high dental fear.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnoses', 'classes': [{'title': 'ADHD', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Other Diagnoses', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Parent report of child diagnoses.', 'unitOfMeasure': 'Participants'}, {'title': "Mother's education", 'classes': [{'title': '<High school', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'High school', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Some college of vocational', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'College degree', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Parent report of mother's education.", 'unitOfMeasure': 'Participants'}, {'title': "Father's education", 'classes': [{'title': '<High school', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'High school', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Some college or vocational', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'College degree', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Not provided', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Parent report of father's education.", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-18', 'size': 1291714, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-02T12:43', 'hasProtocol': True}, {'date': '2019-11-19', 'size': 158354, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-12T15:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2015-04-24', 'resultsFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-01', 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrodermal Activity (EDA) - Skin Conductance Level (SCL)', 'timeFrame': 'Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.', 'description': 'Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress.'}, {'measure': 'Electrodermal Activity (EDA) - Non-specific Skin Conductance Responses (NS-SCR)', 'timeFrame': 'Recorded continuously for three minutes prior to cleaning, through duration of cleaning (approximately 10-45 minutes), and for three minutes at end of cleaning for each dental cleaning.', 'description': 'Electrodermal activity (EDA) is a non-invasive measure of the ability of the skin to conduct an electrical current, which increases when the sympathetic "fight or flight" nervous system is activated during times of stress. Each unique increase \\>0.05uS in the EDA waveform is counted as an NS-SCR, indicating a increase in sympathetic nervous system activation; NS-SCRs are measured as a frequency per minute (calculated as the number of NS-SCRs/time).'}], 'secondaryOutcomes': [{'measure': "Children's Dental Behavior Rating Scale (CDBRS)", 'timeFrame': 'Videorecorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'The CDBRS is a video-coded measure of overt distress behaviors exhibited by children during a routine dental visit. A research team member marks the presence or absence of three distress behaviors (mouth movement, head movement, forehead movement) and the presence or absence and the severity of two distress behaviors (whimper/cry/scream, verbal stall or delay) during each one-minute interval of a five-minute recording of a child receiving prophylaxis during their dental cleaning. Coding is conducted by a trained research team member who achieves strong inter-rater reliability with a second trained rater on a representative sample of children with and without ASD. Raw scores (range=0-45) are converted to a scale score ranging from 1 to 100, with higher scores indicating greater distress.'}, {'measure': 'Whimper, Cry, Scream Duration', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Duration of whimpers, cries, or screams, as scored by video coding.'}, {'measure': 'Whimper, Cry, Scream Frequency', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of whimpers, cries, or screams, as scored by video coding.'}, {'measure': 'Mouth Movement Frequency', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of mouth movement impeding treatment, as scored by video coding.'}, {'measure': 'Head Movement Frequency', 'timeFrame': 'Video-recorded throughout dental cleaning (approximately 10-45 minutes); coded at a later time for the first five minutes of dental prophylaxis.', 'description': 'Frequency of head movement away from the dentist and/or equipment impeding treatment, as scored by video coding.'}, {'measure': 'Faces Pain Scale - Revised', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1-2 minutes)', 'description': 'The Faces Pain Scale - Revised is single-item self-report measure used to assess the perception and intensity of pain in children. The scale is comprised of six faces depicting increasing levels of pain ranging from a neutral expression (no pain) to a face showing severe pain. Each face corresponds to a numerical value on a 0-10 scale (0, 2, 4, 6, 8, 10). Higher scores indicate greater perception and intensity of pain.'}, {'measure': 'Dental Sensory Sensitivity Scale', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 3 minutes)', 'description': 'The Dental Sensory Sensitivity Scale is a child-report measure assessing the presence and magnitude of discomfort with different sensory stimuli in the dental environment (i.e., tactile, auditory, proprioceptive). The scale is comprised of 6 items rated on a 3-point Likert scale ranging from 0 (not at all) to 2 (a lot). Scores range from 0 - 12 with higher scores indicating greater sensory discomfort during routine dental treatment.'}, {'measure': 'Anxiety and Cooperation Scale', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1 minute)', 'description': "The Anxiety and Cooperation Scale (A \\& C Scale) has been shown to assess children's anxiety, fear, and cooperation as rated by dentists, and has good established reliability and validity. Following a routine dental cleaning, the dentist rated overall patient behavior during treatment using a one-item Likert scale ranging from 0 (relaxed, smiling, demonstrates desired behavior, complies with demands) to 5 (out of control, loud crying, reverts to primitive flight responses, physical restraint required)."}, {'measure': 'Frankl Scale', 'timeFrame': 'Completed at the end of each dental cleaning (approximately 1 minute)', 'description': "The Frankl Scale is dentist-report measure of a child's overall behavior during a dental visit. It is an observational, single-item measure that includes four behavioral categories, each assigned a numerical value (1=definitely negative, 2=negative, 3=positive, 4=definitely positive). Higher scores indicate greater cooperation and less distress."}, {'measure': 'Duration', 'timeFrame': 'Time from beginning to end of dental cleaning (approximately 10-45 minutes); recorded for each visit', 'description': 'The length of time to complete the dental cleaning. Used for cost-analysis of the intervention.'}, {'measure': 'Number of Hands Used to Restrain Child', 'timeFrame': 'Recorded throughout the dental cleaning (approximately 10-45 minutes)', 'description': 'The maximum number of hands (at any one time) required to restrain the child during the dental cleaning experience was utilized as a measure of cost and also a measure of uncooperative behavior. This variable was recorded on researcher notes during the dental cleaning and was verified using the videotape of the dental cleaning. Scoring included presence/absence as well as the number of hands used for restraint purposes during the cleaning.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sensory processing', 'oral care', 'electrodermal activity', 'cooperation', 'anxiety', 'distress', 'stress', 'behavior', 'occupational therapy'], 'conditions': ['Autism']}, 'referencesModule': {'references': [{'pmid': '25871593', 'type': 'BACKGROUND', 'citation': 'Cermak SA, Stein Duker LI, Williams ME, Lane CJ, Dawson ME, Borreson AE, Polido JC. Feasibility of a sensory-adapted dental environment for children with autism. Am J Occup Ther. 2015 May-Jun;69(3):6903220020p1-10. doi: 10.5014/ajot.2015.013714.'}, {'pmid': '25114916', 'type': 'BACKGROUND', 'citation': 'Stein LI, Lane CJ, Williams ME, Dawson ME, Polido JC, Cermak SA. Physiological and behavioral stress and anxiety in children with autism spectrum disorders during routine oral care. Biomed Res Int. 2014;2014:694876. doi: 10.1155/2014/694876. Epub 2014 Jul 10.'}, {'pmid': '23756306', 'type': 'BACKGROUND', 'citation': 'Stein LI, Polido JC, Cermak SA. Oral care and sensory over-responsivity in children with autism spectrum disorders. Pediatr Dent. 2013 May-Jun;35(3):230-5.'}, {'pmid': '22917131', 'type': 'BACKGROUND', 'citation': 'Stein LI, Polido JC, Cermak SA. Oral care and sensory concerns in autism. Am J Occup Ther. 2012 Sep-Oct;66(5):e73-6. doi: 10.5014/ajot.2012.004085.'}, {'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': '21592164', 'type': 'BACKGROUND', 'citation': 'Stein LI, Polido JC, Mailloux Z, Coleman GG, Cermak SA. Oral care and sensory sensitivities in children with autism spectrum disorders. Spec Care Dentist. 2011 May-Jun;31(3):102-10. doi: 10.1111/j.1754-4505.2011.00187.x.'}, {'pmid': '37266941', 'type': 'DERIVED', 'citation': 'Stein Duker LI, Como DH, Jolette C, Vigen C, Gong CL, Williams ME, Polido JC, Florindez-Cox LI, Cermak SA. Sensory Adaptations to Improve Physiological and Behavioral Distress During Dental Visits in Autistic Children: A Randomized Crossover Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316346. doi: 10.1001/jamanetworkopen.2023.16346.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to examine the efficacy of a sensory adapted dental environment (SADE) for children who have difficulty tolerating oral care in the dental clinic. The investigators hypothesize that adapting the sensory environment in the dental office by modifying the sounds, sights,and tactile experiences will result in decreased anxiety, increased cooperation, and fewer behavior problems for children with Autism Spectrum Disorders (ASD). This has the potential to contribute to increased child comfort as well as safer, more efficient, and less costly treatment for a large population, as potentially more than one-fourth of all children may benefit from a sensory adapted dental environment.', 'detailedDescription': "This project, which builds upon the investigator's previous R34 National Institute of Dental and Craniofacial Research (NIDCR) Planning and Feasibility study, is designed to examine the efficacy of a sensory adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorders (ASD). Children with ASD often exhibit sensory over-responsivity when confronted with experiential aspects of dental visits such as exposure to bright fluorescent lighting, touch in or around the mouth, or the texture and smell of various oral care products. This often results in increased anxiety and negative behavioral responses which hinder the dentist's ability to perform treatment. In the proposed project, the investigators test a SADE intervention designed to reduce children's anxiety and negative responses during oral care.\n\nThe SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.\n\nThe specific aims are to conduct a randomized clinical trial in order to:\n\n1. Determine if SADE, relative to a regular dental environment (RDE), reduces physiological anxiety and negative responses (behavioral distress, perception of pain, sensory discomfort) during dental cleaning for children with ASD.\n2. Identify whether physiological anxiety mediates the beneficial effects of the intervention and whether severity of ASD and communication ability, or dental anxiety, sensory over-responsivity, and age act as moderating variables.\n3. Assess the quality of care and cost effectiveness/savings of the dental cleaning associated with SADE.\n\nResearch participants will be 220 ethnically diverse children aged 6-12 years. Using a randomized counterbalanced study design, each child will undergo two dental cleanings four months apart: one dental cleaning in RDE and one dental cleaning in SADE.\n\nThis project is significant because it is the first full-scale trial of an intervention designed to reduce oral care problems in children with ASD. It is theoretically important because it will elucidate the mechanisms that underlie the effects of the SADE intervention. Based on the study findings, the investigators will develop a model to transform the standard of pediatric dental care by modifying the sensory qualities of the dental environment. This model will have the potential to be utilized in dental clinics worldwide. As such, the project promises to have a major public health impact insofar as the potential gains in oral health, child comfort, and cost-savings will be dramatic, potentially applying to more than one-fourth of all children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of autism using ADOS;\n* Parents speak English or Spanish;\n* Have experienced at least one prior dental cleaning;\n* In need of an oral cleaning (no previous cleaning within past four months).\n\nExclusion Criteria:\n\n* Cleft palate or other oral condition which makes dental care more difficult than usual practice;\n* Prescription of anti-cholinergic drugs (which may alter EDA);\n* Presence of orthodontia (braces);\n* Significant motor impairment, such as cerebral palsy;\n* Any known genetic, endocrine, or metabolic dysfunctions;\n* Participation in the R34 SADE pilot study;\n* Any medical condition such as significant cardiac problems that would place the individual at increased risk in the study.'}, 'identificationModule': {'nctId': 'NCT02430051', 'acronym': 'SADE-2', 'briefTitle': 'Sensory Adapted Dental Environments to Enhance Oral Care for Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern California'}, 'officialTitle': 'Sensory Adapted Dental Environments to Enhance Oral Care for Children (SADE-2)', 'orgStudyIdInfo': {'id': 'DE024978-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Regular Dental Environment', 'description': 'There are two dental environments - the regular dental environment and the sensory dental environment; each child will be randomized to which is first. In the Regular dental environment no sensory characteristics of the dental environment are altered, the cleaning is conducted as per usual.'}, {'type': 'EXPERIMENTAL', 'label': 'Sensory Adapted Dental Environment', 'description': 'In the Sensory Adapted Dental Environment the sensory characteristics of the dental environment are altered (visual, auditory, and tactile adaptations).', 'interventionNames': ['Behavioral: Sensory Adapted Dental Environment']}], 'interventions': [{'name': 'Sensory Adapted Dental Environment', 'type': 'BEHAVIORAL', 'otherNames': ['SADE Intervention'], 'description': 'The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.', 'armGroupLabels': ['Sensory Adapted Dental Environment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Sharon Cermak, EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern California', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sharon Cermak', 'investigatorAffiliation': 'University of Southern California'}}}}