Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-28 @ 7:20 AM
Study NCT ID:
NCT04082104
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2019-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013342', 'term': 'Stuttering'}], 'ancestors': [{'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2019-08-31', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measuring the stuttering severity index in narrative and conversational contexts by using Stuttering Severity Instrument version 3 (scale ranges from very mild to very severe)', 'timeFrame': 'baseline', 'description': 'Using SSI-3 to evaluate stuttering in both conversational and narrative contexts'}], 'secondaryOutcomes': [{'measure': 'Comparison between the stuttering severity indices in narrative and conversational contexts (comparing the results of the primary outcome) by using the Statistical Package for the Social Sciences', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stuttering']}, 'referencesModule': {'references': [{'pmid': '22269580', 'type': 'BACKGROUND', 'citation': "Byrd CT, Logan KJ, Gillam RB. Speech disfluency in school-age children's conversational and narrative discourse. Lang Speech Hear Serv Sch. 2012 Apr;43(2):153-63. doi: 10.1044/0161-1461(2011/10-0068). Epub 2012 Jan 23."}, {'pmid': '26945438', 'type': 'BACKGROUND', 'citation': 'Constantino CD, Leslie P, Quesal RW, Yaruss JS. A preliminary investigation of daily variability of stuttering in adults. J Commun Disord. 2016 Mar-Apr;60:39-50. doi: 10.1016/j.jcomdis.2016.02.001. Epub 2016 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess stuttering severity in both narration and conversation in adults and adolescences in order to determine which situation is more stressful so that more reliable and accurate measures for diagnosis can be done. Also this study will help in determining the best line of management of stuttering.', 'detailedDescription': "Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions and prolongations of sounds, syllables, words or phrases as well as involuntary silent pauses or blocks.\n\nIn the world, approximately 1% of the adult population suffer from stuttering. Stuttering has severe impact on the overall quality of the person's life such as anxiety, stress, shame, low self-esteem and negative affectivity .It also affects his educational attainment, his attractiveness and work life as he avoids employment.\n\nStuttering varies in severity, frequency and duration from situation to situation. So its dynamics are best understood within discourse contexts that involve interactions with other people. Clinicians typically rely on spontaneous conversational samples for analyzing speech disfluencies. They have good validity, but the use of a more structured form of speech may allow for more efficient, reliable elicitation of stuttering related behaviours and better understanding of the nature of stuttering.\n\nNarration offers a more structured context than conversation because storytellers must weave together information about the characters, the circumstances and actions. Also, narration often contains more complex language than conversation and put the whole responsibility on the speaker for planning and conveying the information to the listener, compared to conversation where two or more speakers co-construct the stream of topics and comments. Thus, narration places more linguistic, cognitive and communicative demands on speakers than does conversation.\n\nA research was done on six adult participants and showed that some of them stuttered more during conversation and others stuttered more during narration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stuttering adults and adolescences will be referred from the outpatient clinic of Phoniatric Unit at Assiut University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age :11-50\n2. Gender : both sex will be included in the study\n3. IQ \\>85\n4. No previous therapy\n\nExclusion Criteria:\n\n* 1\\. Presence of any other speech, language, physical or neuropsychatric disorders.'}, 'identificationModule': {'nctId': 'NCT04082104', 'briefTitle': 'Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts', 'orgStudyIdInfo': {'id': 'Stuttering'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Stuttering Severity Instument version 3', 'type': 'DIAGNOSTIC_TEST', 'description': "Riley's Stuttering Severity Instrument is used for the objective assessment of severity and in other examinations of stuttered speech. Current versions of the instrument measures three parameters: 1) stuttering frequency; 2) duration of selected stutters; 3) observed physical concomitants."}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Maria Alfons Fouad', 'investigatorAffiliation': 'Assiut University'}}}}