Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02105402
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Efficacy for Developmental Motor Speech Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-03-29', 'releaseDate': '2019-01-04'}], 'estimatedResultsFirstSubmitDate': '2019-01-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D066229', 'term': 'Speech Sound Disorder'}, {'id': 'D013065', 'term': 'Speech Intelligibility'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013060', 'term': 'Speech'}, {'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in speech motor control', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': 'Formal assessment of the neuromotor integrity of the motor speech system will be carried out using the verbal motor production assessment for children (VMPAC).'}, {'measure': 'Change in speech articulation', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': 'Assessment of speech articulation will be carried out using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.'}, {'measure': 'Change in word-level speech intelligibility', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': "Word level assessment of speech intelligibility will be carried out using the Children's speech Intelligibility Measure."}, {'measure': 'Change in Functional Communication:', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': "Focus on the Outcomes of Communication Under Six (FOCUS), is a parent questionnaire that captures preschool children's communication abilities as they participate in real-world situations."}, {'measure': 'Change in criterion-referenced measure of speech motor control.', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': 'Criterion-referenced assessment of the motor speech system will be carried out using a set of probe words. The audio-video recordings of the probe words will be analyzed by three qualified and blinded speech language pathologists.'}, {'measure': 'Change in phonological processes', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': 'Phonological processes will be assessed using the Diagnostic Evaluation of Articulation and Phonology (DEAP) test.'}, {'measure': 'Change in sentence-level speech intelligibility', 'timeFrame': 'At baseline and following 10 weeks of intervention or waitlist delay', 'description': "Sentence-level assessment of speech intelligibility will be carried out using the Beginner's Intelligibility Test."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Speech sound disorders', 'Randomized Controlled Trial', 'Speech intelligibility', 'PROMPT treatment', 'Developmental motor speech disorders', 'Children', 'Functional outcomes', 'Treatment efficacy'], 'conditions': ['Randomized Controlled Trial for Speech Disorders in Children']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to carry out a high-level treatment efficacy study on children with speech sound disorders with motor speech involvement (SSD-MSI) using a well-controlled Randomized Controlled Trial design.\n\nThe intervention of choice is the Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) approach, which has been effective in treating motor speech disorders in adults and in children with autism and cerebral palsy.', 'detailedDescription': "The results of this study will allow us to determine if there is a causal relationship between PROMPT treatment and outcome measures and predict how much improvement can be expected from this therapy. This study is being conducted as a part of a multicenter clinical trial in the province of Ontario, Canada with three sites: The John McGivney Children's Centre in Windsor, The ErinoakKids Centre for Treatment and Development in Mississauga, and The Speech and Stuttering Institute in Toronto.\n\nThe study integrity will be monitored by an arms-length, external agency, The Applied Health Research Centre (AHRC) at St. Michael's Hospital in Toronto. The study is coordinated by the Department of Speech-Language Pathology at the University of Toronto and funded by the PROMPT Institute in Santa Fe, New Mexico."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The child is between 3 and 10 Years.\n* English is the primary language spoken by the primary caregiver at home.\n* Hearing/Vision (corrected is acceptable- e.g., spectacles) is within normal limits.\n* Readiness for direct speech therapy.\n* Age appropriate social interaction and play skills.\n* Age appropriate or mildly delayed receptive language skills.\n* Normal to any amount of delay in expressive language development.\n* Moderate to severe speech sound disorder.\n* Age appropriate or slight delay non-verbal intelligence.\n* 4 red flags for motor speech involvement.\n\nExclusion Criteria:\n\n* Signs and symptoms suggesting global motor involvement (Cerebral Palsy).\n* Signs and symptoms suggesting Autism Spectrum Disorders.\n* Oral structural deficits.\n* Feeding impairments.\n* Signs of Dysarthric speech or significant drooling.\n* Prosodic and / or resonance disorders.\n* Diagnosis of Childhood Apraxia of Speech features'}, 'identificationModule': {'nctId': 'NCT02105402', 'briefTitle': 'Treatment Efficacy for Developmental Motor Speech Disorders', 'organization': {'class': 'OTHER', 'fullName': 'The Prompt Institute'}, 'officialTitle': 'Treatment Efficacy for Developmental Motor Speech Disorders: A PROMPT Randomized Control Trial', 'orgStudyIdInfo': {'id': 'PROMPT-29142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group - PROMPT therapy', 'description': 'Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT)', 'interventionNames': ['Behavioral: PROMPT']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist or Delay Group', 'description': 'Participants in this group are on the waitlist for 10 weeks'}], 'interventions': [{'name': 'PROMPT', 'type': 'BEHAVIORAL', 'otherNames': ['PROMPT therapy'], 'description': 'The PROMPT approach utilizes a motor-speech hierarchy (MSH) to guide speech language pathologists (SLP) in selecting speech movement goals for treatment. PROMPT treatment generally proceeds systematically in a bottom-up fashion starting with the lowest subsystem in the hierarchy where a child has control issues. Furthermore, in the PROMPT approach specific techniques are used to stimulate sensory input that are assumed to facilitate the formation of sensory-motor pathways required for the acquisition and accurate production of speech movement patterns. As the speech motor behaviors are established, the clinician reduces the number of cues and the frequency and immediacy of feedback and practices transfer and generalization activities.', 'armGroupLabels': ['Intervention Group - PROMPT therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L5K 2N6', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'ErinoakKids Centre for Treatment and Development', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'M3B 3J5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Speech and Stuttering Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N9C 4C2', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': "The John McGivney Children's Centre of Essex County", 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'Aravind Namasivayam, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}, {'name': 'Deborah Hayden, M.A.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The PROMPT Institute, Santa Fe, NM, 87505 USA'}, {'name': 'Pascal van Lieshout, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Prompt Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-04', 'type': 'RELEASE'}, {'date': '2019-03-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The Prompt Institute'}}}}