- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05133479
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties (LK!2)
Translating Research Into School-based Practice Via Small-group, Language-focused Comprehension Intervention
In the proposed project, the investigators will conduct a multisite randomized controlled trial (RCT) to determine the efficacy of Let's Know!2, a small-group, language focused comprehension intervention, on children's lower- and higher-level language skills and comprehension skills in the short- and long-term (Specific Aims 1 and 2). The investigators will also explore whether intervention effects are moderated by dosage, initial language skill, developmental language disorder (DLD) status, word reading skill, nonverbal IQ, and family socioeconomic status (Specific Aim 3).
Children who have low language skills and are thus at risk for reading comprehension difficulties will participate in the study. Children will be randomly assigned to receive Let's Know! in small groups at their respective schools or to a business-as-usual control condition. The investigators will measure children's language and comprehension skills at the beginning and end of Grade 1 as well as in Grade 2 and Grade 3. The investigators hypothesize that children who experience Let's Know! will end Grade 1 with higher language skills than children in the control condition and that this will translate into better listening and reading comprehension skills as these children matriculate through elementary school.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02192
- MGH Institute of Health Professions
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parental consent to participate in the research;
- Enrollment in Grade 1;
- Scores below the 30th percentile on the OWL Language Screener
- Basic English proficiency as reported by parents/teachers
Exclusion Criteria:
- Unable to speak or understand English at a basic level, as reported by parents/teachers;
- Profound disability that severely impairs classroom participation, as reported by teachers;
- Serious behavior issue that severely impairs classroom participation, as reported by teachers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention
Participants receive the Let's Know! intervention in small groups as provided by research staff
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Let's Know!2 is an 22-week intervention spanning 1 school year.
Each week features 4, 20-30 minute lessons targeting lower-level and higher-level language skills.
Within units, instructors and children progress through specific types of lessons to meet language-focused learning objectives.
LK!2 was adapted from the original Let's Know! curriculum (LARRC, 2016).
The adaption from LK! to LK! made lessons appropriate for small groups of Grade 1 students with low language skills.
Adaptations focused on (1) simplification of language input, (2) increased scaffolding, (3) attention to distributed practice, (4) materials to support diversity and inclusion, and (5) enhanced interventionist training.
LK!2 comprised 76 20-30 min lessons across four units (fiction, animals, earth materials, folktales) as implemented by trained research staff (i.e., interventionists).
Other Names:
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No Intervention: Business-As-Usual
Participants continue to receive only their typical classroom instruction (i.e., no small groups)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment unit 1 (fiction) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time Frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 1 (fiction) and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
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approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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Treatment unit 2 (animals) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time Frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 2 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
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approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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Treatment unit 3 (earth materials) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time Frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses children's definitional knowledge of the 8 vocabulary words taught in unit 3 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible.
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approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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Treatment unit 4 (folktales) vocabulary knowledge as assessed by the LARRC Unit Vocabulary Curriculum-Aligned Measure (CAM) total correct
Time Frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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The Language and Reading Research Consortium (LARRC) Unit Vocabulary Curriculum-Aligned Measure (CAM) assesses change in children's definitional knowledge of the 8 vocabulary words taught in unit 4 and results in a total score of definitional specificity with 2 points possible for each word for a total of 16 points possible per CAM.
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approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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Change in vocabulary knowledge as assessed by the LARRC Target Word Knowledge
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in vocabulary knowledge as assessed by the Language and Reading Research Consortium (LARRC) Target Word Knowledge measures which assesses definitional knowledge of a sampling of words taught across the 4 treatment units, in addition to several words not taught in the intervention.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in breadth of vocabulary as assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5)
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in the breadth of vocabulary will be assessed by the Peabody Picture Vocabulary Test 5th Edition (PPVT-5), a standardized measure of the number of words that a child should know compared to a nationwide sample of age-matched peers.
Children point to one picture out of four that best represents a word spoken by the examiner.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Treatment unit 1 (fiction) comprehension monitoring as assessed by the LARRC Unit 1 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time Frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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The Language and Reading Research Consortium (LARRC) Unit 1 (fiction) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
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approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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Treatment unit 2 (animals) comprehension monitoring as assessed by the LARRC Unit 2 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time Frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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The Language and Reading Research Consortium (LARRC) Unit 2 (animals) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
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approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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Treatment unit 3 (earth materials) comprehension monitoring as assessed by the LARRC Unit 3 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time Frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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The Language and Reading Research Consortium (LARRC) Unit 3 (earth materials) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
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approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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Treatment unit 4 (folktales) comprehension monitoring as assessed by the LARRC Unit 4 Comprehension Monitoring Curriculum-Aligned Measure (CAM)
Time Frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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The Language and Reading Research Consortium (LARRC) Unit 4 (folktales) Comprehension Monitoring Curriculum-Aligned Measure (CAM) assesses children's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown.
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approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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Change in child's ability to monitoring comprehension, as assessed by the LARRC Comprehension Monitoring Test
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in comprehension monitoring as assessed by the Language and Reading Research Consortium (LARRC) Comprehension Monitoring Test, which assesses child's ability to detect inconsistencies in stories read to them and to recall a strategy to fix their comprehension breakdown from the strategies learned across all 4 treatment units.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Treatment unit 1 (fiction) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Time Frame: approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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The Language and Reading Research Consortium (LARRC) Unit 1 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
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approximately 6 weeks after start of intervention, at the end of Unit 1 treatment
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Treatment unit 2 (animals) knowledge of text structures as assessed by the LARRC Unit 2 Text Structure Curriculum-Aligned Measure (CAM)
Time Frame: approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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The Language and Reading Research Consortium (LARRC) Unit 2 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
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approximately 12 weeks after start of intervention, at the end of Unit 2 treatment
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Treatment unit 3 (earth materials) knowledge of text structures as assessed by the LARRC Unit 3 Text Structure Curriculum-Aligned Measure (CAM)
Time Frame: approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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The Language and Reading Research Consortium (LARRC) Unit 3 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to an expository text passage and answer questions about the passage, such as main idea and important details.
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approximately 18 weeks after start of intervention, at the end of Unit 3 treatment
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Treatment unit 4 (folktales) knowledge of text structures as assessed by the LARRC Unit 1 Text Structure Curriculum-Aligned Measure (CAM)
Time Frame: approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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The Language and Reading Research Consortium (LARRC) Unit 4 Text Structure Curriculum-Aligned Measure (CAM) assesses children's ability to listen to a story and answer questions about the stories' structure, such as characters, settings, problem, and resolution.
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approximately 22 weeks after start of intervention, at the end of Unit 4 treatment
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Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the LARRC Inference Task
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in child's ability to use their knowledge to fill in the gaps in short stories, as assessed by the Language and Reading Research Consortium (LARRC) Inference Task, which assesses child's ability to answer questions about short stories they have heard presented by the examiner.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in story retelling abilities, as assessed by the CUBED Narrative Retell measure
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in child's ability to accurately and completely retell a story as assessed by the CUBED Narrative Retell measure.
The examiner tells the child a story using pictures and the child retells the story back to the examiner.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in ability to understand stories, as assessed by the Test of Narrative Language
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in the child's ability to understand stories, as assessed by the Test of Narrative Language.
The examiner tells the child stories and asks the child questions about those stories.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in a child's ability to comprehend short passages read aloud to them, as assessed by the LARRC Listening Comprehension Measure, which requires a child to listen to two short stories and answer questions about those stories
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Reading Comprehension Measure
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in a child's ability to comprehend short passages they read, as assessed by the LARRC Listening Comprehension Measure, which requires a child to read two short stories and answer questions about those stories
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in reading comprehension, as assessed by the norm-referenced Gates-McGinitie Reading Test
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in child's ability to comprehend short passages that the child reads to themselves, as assessed by their ability to answer questions about those passages using the norm-referenced Gates-McGinitie Reading Test
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nonverbal intelligence as assessed by the Kaufman Brief Intelligence Test - Second Edition nonverbal intelligence (matrices) subtest
Time Frame: right before intervention starts
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The nonverbal intelligence (matrices) subtest of the Kaufman Brief Intelligence Test - Second Edition measures children's ability to to solve new problems, perceive relationships and complete visual analogies without taxing language skills.
The matrices subtest requires the child to point to the picture that would complete a picture or abstract design.
Nonverbal intelligence will be tested as a moderator of treatment effects in analyses.
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right before intervention starts
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Change in timed word and nonword reading, as assessed by the Test of Word Reading Efficiency - Second Edition
Time Frame: right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Change in timed word and nonword reading accuracy will be assessed by asking children to read as many words and then nonwords as possible in 45 seconds each, as measured by the Test of Word Reading Efficiency - Second Edition.
Timed word and nonword reading will be tested as a moderator of treatment effects in the analyses as well as a distal treatment outcome.
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right before intervention starts, right after intervention ends, one year post intervention, and 2 years post intervention
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Language comprehension skills, as assessed by the OWL Language Screener
Time Frame: right before intervention starts
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Language comprehension skills are assessed by the The OWL Language Screener, which requires children to point to the one picture out of four pictures that best represents a sentence.This measure will be tested as a moderator of treatment effects in analyses as well as the measure to determine if the child has language weaknesses to qualify for treatment.
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right before intervention starts
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Academic performance will be assessed by the Massachusetts or Ohio State Assessments of Reading
Time Frame: 2 years after intervention ends
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Children's academic reading performance will be assessed by the Massachusetts or Ohio State Reading Assessments to examine distal treatment outcomes on state assessments of reading
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2 years after intervention ends
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tiffany P Hogan, PhD, MGH Institute of Health Professions
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Communication Disorders
- Language Disorders
- Learning Disabilities
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Language Development Disorders
- Specific Language Disorder
- Dyslexia
Other Study ID Numbers
- 2020P002508
- 1R01DC018823-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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