Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 6:33 PM
Study NCT ID:
NCT06001866
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007805', 'term': 'Language Development Disorders'}, {'id': 'D000080888', 'term': 'Specific Language Disorder'}], 'ancestors': [{'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'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deevy@purdue.edu', 'phone': '765-496-1821', 'title': 'Dr. Patricia Deevy, Research Associate', 'organization': 'Purdue University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 5 Mins. for Learned Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Learned 5 min RSR condition', 'categories': [{'measurements': [{'value': '3.79', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '5.31', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Learned 5 min RS condition', 'categories': [{'measurements': [{'value': '2.86', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.00001', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after end of Day 2 (second day) learning period.', 'description': 'Five minutes after second learning session, child is asked to recall and say the word associated with each novel action learned under each of the two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Learned items, each of the four verbs was tested with videos of two of the agent-object pairs the child had seen during the learning period, for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.', 'unitOfMeasure': 'number of verbs recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 5 Mins. for Generalized Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Generalized 5 min RSR condition', 'categories': [{'measurements': [{'value': '3.79', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '4.85', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Generalized 5 min RS condition', 'categories': [{'measurements': [{'value': '2.43', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.00001', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes after end of Day 2 (second day) learning period.', 'description': 'Five minutes after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Generalized items each of the four verbs was tested with videos of two agent-object pairs that were new (that the child had not seen during the learning period), for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.', 'unitOfMeasure': 'number of verbs recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 1 Week for Learned Items.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Learned 1 week RSR condition', 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '5.46', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'RS condition', 'categories': [{'measurements': [{'value': '3.50', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '3.77', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.78', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<.00001', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Learned items, each of the four verbs was tested with videos of two of the agent-object pairs the child had seen during the learning period, for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.', 'unitOfMeasure': 'number of verbs recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 1 Week for Generalized Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Generalized 1 week RSR condition', 'categories': [{'measurements': [{'value': '3.57', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Generalized 1 week RS condition', 'categories': [{'measurements': [{'value': '3.57', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=1.00', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.00001', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Generalized items, each of the four verbs was tested with videos of two agent-object pairs that were new (that the child had not seen during the learning period), for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.', 'unitOfMeasure': 'number of verbs recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Accuracy of Verb Recall (Number of Verbs Correctly Recalled) in a New Structure in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Repeated Spaced Retrieval', 'categories': [{'measurements': [{'value': '5.29', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '10.23', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Repeated Study', 'categories': [{'measurements': [{'value': '5.57', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.75', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'Child is asked to describe the video of a novel action using the novel verb in a frame different from the one learned (i.e.,"X likes to VERB the Y") in repeated spaced retrieval and repeated study conditions. Each verb is tested with four items: three items made use of videos of agent-object pairs the child had seen during the learning period and one item used an agent-object pair that was new. There were eight items total per condition.', 'unitOfMeasure': 'number of verbs recalled', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Verb Recognition (Number of Words Accurately Identified) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions for Learned Items.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.\n\nRetrieval-based verb learning: Repeated Spaced Retrieval condition: Novel verbs are practiced on Day 1 using repeated study and retrieval trials. At the start of the session, retrieval trials immediately follow study trials; remaining retrieval trials are spaced for each word (occurring after 3 other words have intervened). This practice schedule is repeated the next day (Day 2).\n\nRetrieval-based verb learning: Repeated Study condition: Novel verbs are practiced on 2 consecutive days using repeated study trials only, (with no retrieval practice).'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.\n\nRetrieval-based verb learning: Repeated Spaced Retrieval condition: Novel verbs are practiced on Day 1 using repeated study and retrieval trials. At the start of the session, retrieval trials immediately follow study trials; remaining retrieval trials are spaced for each word (occurring after 3 other words have intervened). This practice schedule is repeated the next day (Day 2).\n\nRetrieval-based verb learning: Repeated Study condition: Novel verbs are practiced on 2 consecutive days using repeated study trials only, (with no retrieval practice).'}], 'classes': [{'title': 'Learned RSR Condition', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '7.92', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Learned RS condition', 'categories': [{'measurements': [{'value': '7.00', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.62', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after the learning session, child is asked to indicate (by pointing) which of 2 video options is referred to upon hearing a sentence using a novel word learned in either the repeated spaced retrieval or repeated study condition. Each verb is tested with two items which used videos of agent-object pairs that the child had seen during the learning period, for a total of eight items.', 'unitOfMeasure': 'verbs with correct video identified', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Verb Recognition (Number of Words Accurately Identified) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions for Generalized Items.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'title': 'Generalized RSR condition', 'categories': [{'measurements': [{'value': '7.36', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '7.61', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Generalized RS condition', 'categories': [{'measurements': [{'value': '7.14', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.16', 'groupIds': ['OG000'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.33', 'groupIds': ['OG001'], 'statisticalMethod': 'LSD test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after the learning session, child is asked to indicate (by pointing) which of 2 video options is referred to upon hearing a sentence using a novel word learned in either the repeated spaced retrieval or repeated study condition. Each verb is tested with two items which used videos of agent-object pairs that were new (that the child had not seen during the learning period), for a total of eight items.', 'unitOfMeasure': 'verbs wtih correct video identified', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peabody Picture Vocabulary Test, Fifth Edition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.07', 'spread': '11.28', 'groupId': 'OG000'}, {'value': '116.69', 'spread': '10.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=.54', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Test completed at start of study', 'description': 'The Peabody Picture Vocabulary is an individually administered, norm-reference test that assesses receptive vocabulary (ability to understand individual words) for children and adults ages 2 years 6 months to 90 years and older. Standard scores are derived from number correct. Standard scores can range from a minimum of 40 and 160. Standard scores between 85 and 115 (1 standard deviation above and below the mean of 100) are interpreted as reflecting receptive vocabulary levels expected for age. Scores below 85 are interpreted as reflecting receptive vocabulary levels below what is expected for age.Scores above 115 are interpreted as reflecting receptive vocabulary levels above what is expected for age.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Education in Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'OG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.71', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '17.42', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'information collected at start of study', 'description': "Educational attainment of child's mother in terms of years of education", 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'FG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Children with DLD are recruited primarily through speech pathologists and preschool teachers. They are provided with eligibility guidelines and a parent letter. Once the parent is given the letter, they choose to contact us, if interested.\n\nChildren with typical language development are recruited through advertising in preschools.', 'preAssignmentDetails': 'Children are initially tested to see if they meet the inclusionary and exclusionary criteria of Developmental Language Disorder. These include falling below age level on a language test, while passing a hearing screening, a non-verbal IQ test, and an autism screener. Many children who are recruited and consented do not meet all these criteria pointing to the fact that DLD is not readily recognizable to non-professionals (parents, preschool teachers).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Children With Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.'}, {'id': 'BG001', 'title': 'Children With Typical Language Development', 'description': 'Children whose language development is as expected for their age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.21', 'spread': '5.19', 'groupId': 'BG000'}, {'value': '59.00', 'spread': '5.26', 'groupId': 'BG001'}, {'value': '58.07', 'spread': '5.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Maternal Education in Years', 'classes': [{'categories': [{'measurements': [{'value': '16.71', 'spread': '3.36', 'groupId': 'BG000'}, {'value': '17.42', 'spread': '2.63', 'groupId': 'BG001'}, {'value': '17.06', 'spread': '2.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline population include children who met the inclusionary \\& exclusionary criteria for Developmental Language Disorder or for Typical Language Development. Those who did not meet the criteria are not included.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-24', 'size': 85298, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-05T15:15', 'hasProtocol': True}, {'date': '2023-06-07', 'size': 195331, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-25T09:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Within-participant design in which each child learns words under two conditions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2023-08-03', 'resultsFirstSubmitDate': '2025-07-05', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-25', 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 5 Mins. for Learned Items', 'timeFrame': '5 minutes after end of Day 2 (second day) learning period.', 'description': 'Five minutes after second learning session, child is asked to recall and say the word associated with each novel action learned under each of the two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Learned items, each of the four verbs was tested with videos of two of the agent-object pairs the child had seen during the learning period, for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.'}, {'measure': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 5 Mins. for Generalized Items', 'timeFrame': '5 minutes after end of Day 2 (second day) learning period.', 'description': 'Five minutes after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Generalized items each of the four verbs was tested with videos of two agent-object pairs that were new (that the child had not seen during the learning period), for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.'}, {'measure': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 1 Week for Learned Items.', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Learned items, each of the four verbs was tested with videos of two of the agent-object pairs the child had seen during the learning period, for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.'}, {'measure': 'Verb Recall Accuracy (Number of Verbs Correctly Recalled) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions at 1 Week for Generalized Items', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after second learning session, child is asked to recall and say the word associated with each novel action learned under one of two conditions: a condition in which spaced retrieval trials occurred and one in which there were no retrieval trials. For Generalized items, each of the four verbs was tested with videos of two agent-object pairs that were new (that the child had not seen during the learning period), for a total of 8 recall items. Children were prompted to retrieve/produce the novel verbs in the sentence structure used during learning.'}, {'measure': 'Accuracy of Verb Recall (Number of Verbs Correctly Recalled) in a New Structure in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'Child is asked to describe the video of a novel action using the novel verb in a frame different from the one learned (i.e.,"X likes to VERB the Y") in repeated spaced retrieval and repeated study conditions. Each verb is tested with four items: three items made use of videos of agent-object pairs the child had seen during the learning period and one item used an agent-object pair that was new. There were eight items total per condition.'}, {'measure': 'Verb Recognition (Number of Words Accurately Identified) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions for Learned Items.', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after the learning session, child is asked to indicate (by pointing) which of 2 video options is referred to upon hearing a sentence using a novel word learned in either the repeated spaced retrieval or repeated study condition. Each verb is tested with two items which used videos of agent-object pairs that the child had seen during the learning period, for a total of eight items.'}, {'measure': 'Verb Recognition (Number of Words Accurately Identified) in Repeated Spaced Retrieval (RSR) and Repeated Study (RS) Conditions for Generalized Items.', 'timeFrame': '1 week after Day 2 (second day) learning period.', 'description': 'One week after the learning session, child is asked to indicate (by pointing) which of 2 video options is referred to upon hearing a sentence using a novel word learned in either the repeated spaced retrieval or repeated study condition. Each verb is tested with two items which used videos of agent-object pairs that were new (that the child had not seen during the learning period), for a total of eight items.'}], 'secondaryOutcomes': [{'measure': 'Peabody Picture Vocabulary Test, Fifth Edition', 'timeFrame': 'Test completed at start of study', 'description': 'The Peabody Picture Vocabulary is an individually administered, norm-reference test that assesses receptive vocabulary (ability to understand individual words) for children and adults ages 2 years 6 months to 90 years and older. Standard scores are derived from number correct. Standard scores can range from a minimum of 40 and 160. Standard scores between 85 and 115 (1 standard deviation above and below the mean of 100) are interpreted as reflecting receptive vocabulary levels expected for age. Scores below 85 are interpreted as reflecting receptive vocabulary levels below what is expected for age.Scores above 115 are interpreted as reflecting receptive vocabulary levels above what is expected for age.'}, {'measure': 'Maternal Education in Years', 'timeFrame': 'information collected at start of study', 'description': "Educational attainment of child's mother in terms of years of education"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['word learning', 'word retrieval', 'preschool-aged children'], 'conditions': ['Developmental Language Disorder', 'Specific Language Impairment', 'Language Development']}, 'descriptionModule': {'briefSummary': "Children with developmental language disorder (DLD; also referred to as specific language impairment) experience a significant deficit in language ability that is longstanding and harmful to the children's academic, social, and eventual economic wellbeing. Word learning is one of the principal weaknesses in these children. This project focuses on the word learning abilities of four- and five-year-old children with DLD. The goal of the project is to build on the investigators' previous work to determine whether, as has been found thus far, special benefits accrue when these children must frequently recall newly introduced words during the course of learning. The focus of the current study is verb-learning. The goal of the study is to increase children's absolute levels of verb learning while maintaining the advantage that repeated retrieval holds over comparison methods of learning.", 'detailedDescription': 'Developmental Language Disorder (DLD) affects language learning in an estimated 7% of children. Although much of the research literature has emphasized difficulties learning grammar, children with DLD also have major deficits in vocabulary. In recent work, the investigators have been examining the benefit of retrieval practice to enhance word learning and retention in preschoolers with DLD. The rationale behind this work is grounded in the growing literature in the field of cognitive psychology which shows that repeated practice in retrieving information results in greater long-term retention than continuous study of that information without opportunities for retrieval. In addition, retrieval practice that occurs after a delay-or "spacing" between study of a word and subsequent recall attempts-can lead to stronger effects.\n\nThe investigators have explored the benefits of retrieval practice for preschoolers with DLD and with typical language development (TD), showing that recall and retention for novel words (nouns, adjectives, verbs) were greater when learned using repeated spaced retrieval (RSR) than when learned using repeated study only. Despite benefitting from RSR, children with DLD still showed lower levels of recall than children with TD, in particular in novel verb learning.\n\nIn the current study, the investigators seek to improve the absolute levels of word form recall for verbs by modifying the method used previously. Sixteen children with DLD will be recruited for this study along with 16 children with TD matched on chronological age. Using a within-subjects design, children will learn eight novel verbs, four at a time. Each set of four will be learned over two consecutive days, with two words in the RSR condition and two words in a repeated study condition. The referents for these novel words will be video-recorded transitive actions performed by actors on objects and presented on a laptop screen.\n\nIn the RSR condition, children will initially hear the word paired with a video of a novel action, immediately be asked to recall the word, and then see/hear it again. After three other words are presented, they will be asked to recall the original word again; this "3" spaced retrieval schedule will continue for the rest of the learning session. In the comparison condition, children will simply hear the words paired with a video of the novel action. In this study, during retrieval practice, children will be prompted to respond with a full sentence containing the verb.\n\nRecall of the verbs will be tested after the learning session on the second day and one week later. At one week, children will also complete a syntactic generalization test in which they are prompted to use the novel verb in a type of sentence that is different from the one used during learning. Finally, children will complete a two-alternative recognition test.\n\nThe investigators hypothesize that novel verbs that undergo RSR during the learning period will be learned and recalled better than comparable novel verbs that are assigned to the repeated study condition. This RSR advantage will continue to be observed when the children must use the novel verbs with new actors and objects and will be seen as well in the syntactic generalization test when the children must use the novel verbs in a new sentence frame. Introducing novel verbs representing actions that can be performed on varying objects is expected to improve overall learning. In addition, by having the child produce the verbs in the context of a full sentence, the newly learned verbs should become more integrated with other sentence elements (subjects and direct objects), resulting in a richer representation in memory and consequently, greater recall, recognition, and syntactic flexibility than was observed in the previous novel verb study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '71 Months', 'minimumAge': '48 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a significant deficit in language ability (language test score below cutoff for best sensitivity/specificity) or documented age-appropriate language ability.\n\nnormal hearing no evidence of neurological damage or disease scores on tests of nonverbal intelligence above the intellectual disability range not within Autistic range on Autism screening test native English speaker (can be bilingual)\n\nExclusion Criteria:\n\n* failed hearing screening known neurological damage or disease scores on tests of nonverbal intelligence below the intellectual disability range (standard score less than 75) autism spectrum disorder non-native English speaker'}, 'identificationModule': {'nctId': 'NCT06001866', 'briefTitle': 'Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Retrieval-Based Word Learning in Developmental Language Disorder: Verb Learning', 'orgStudyIdInfo': {'id': '1603017480B'}, 'secondaryIdInfos': [{'id': 'R01DC014708', 'link': 'https://reporter.nih.gov/quickSearch/R01DC014708', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children with Developmental Language Disorder', 'description': 'These children have a significant delay in language development in the absence of hearing impairment, cognitive delay, autism, or neurological injury/disease.', 'interventionNames': ['Behavioral: Retrieval-based verb learning: Repeated Spaced Retrieval condition', 'Behavioral: Retrieval-based verb learning: Repeated Study condition']}, {'type': 'EXPERIMENTAL', 'label': 'Children with typical language development', 'description': 'Children whose language development is as expected for their age.', 'interventionNames': ['Behavioral: Retrieval-based verb learning: Repeated Spaced Retrieval condition', 'Behavioral: Retrieval-based verb learning: Repeated Study condition']}], 'interventions': [{'name': 'Retrieval-based verb learning: Repeated Spaced Retrieval condition', 'type': 'BEHAVIORAL', 'description': 'A set of novel verbs are practiced on 2 consecutive days (the same verbs are used each day). Half of the novel verbs are learned in the repeated spaced retrieval condition and half are learned in the repeated study condition, with the two conditions interleaved on each day.\n\nThe repeated spaced retrieval condition consists of study and retrieval trials. At the start of the sessions, retrieval trials immediately follow study trials. Thereafter, retrieval trials are spaced for each verb, occurring after 3 other words have intervened between the retrieval trial and the last study trial for that verb.', 'armGroupLabels': ['Children with Developmental Language Disorder', 'Children with typical language development']}, {'name': 'Retrieval-based verb learning: Repeated Study condition', 'type': 'BEHAVIORAL', 'description': 'A set of novel verbs are practiced on 2 consecutive days (the same verbs are used each day). Half of the novel verbs are learned in the repeated spaced retrieval condition and half are learned in the repeated study condition, with the two conditions interleaved on each day.\n\nThe repeated study condition consists of study trials only (with no retrieval practice).', 'armGroupLabels': ['Children with Developmental Language Disorder', 'Children with typical language development']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Laurence B. Leonard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue Universtiy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will become available after the results are published or within 12 months from the primary completion date (i.e., the date of final data collection for the primary outcome measure).', 'ipdSharing': 'YES', 'description': 'Data that contribute to our final published results will be made available at www.clinicaltrials.gov.', 'accessCriteria': 'De-identified data will be made publicly available at www.clinicaltrials.gov'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Speech, Language, & Hearing Sciences', 'investigatorFullName': 'Laurence Leonard', 'investigatorAffiliation': 'Purdue University'}}}}