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Improving STEM Outcomes for Young Children With Language Learning Disabilities

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ClinicalTrials.gov Identifier: NCT03438760
Recruitment Status : Terminated (with 2/3 of the data collected, we had to terminate the study because of COVID19.)
First Posted : February 20, 2018
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
University of Delaware
University of Iowa
Information provided by (Responsible Party):
Karla McGregor, Father Flanagan's Boys' Home

Brief Summary:
The sophisticated language of science can be a barrier to Science, Technology, Engineering, and Math (STEM) learning, especially for children who have specific language impairment (SLI). The purpose of this randomized controlled trial is to test vocabulary and grammar interventions embedded in a small-group inquiry-based science instruction for their potential to ameliorate language deficits that impede science learning. Participants will be 54 preschoolers or kindergartners with SLI. Proximal and distal probes will reveal their mastery of taught and generalized language and science concepts.

Condition or disease Intervention/treatment Phase
Specific Language Impairment Behavioral: Science + Phonological Awareness Behavioral: Science + Grammar Intervention Behavioral: Science + Vocabulary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will assigned to one of three groups in parallel for the duration of the study.
Masking: None (Open Label)
Masking Description: Although it is impossible to mask the assessors of the proximal outcome measures, those assessing some of the distal outcomes can be masked. Specifically, the people scoring the results of the Lens on Science Assessment (a distal measure of generalized scientific content and process) will be masked to the treatment arm assignments. Also, the people transcribing, coding, and analyzing the words and gestures used in the science story retell task (a distal measure of generalized scientific practice outcomes) will be masked to the treatment arm assignments.
Primary Purpose: Treatment
Official Title: Improving STEM Outcomes for Young Children With Language Learning Disabilities by Intervening at the Intersection of Language and Scientific Thought.
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Science + Phonological Awareness
In all conditions, science is taught via the Full Option Science System Next Generation Edition (FOSS, 2015, https://www.fossweb.com/) curriculum that involves 1) Prediction, 2) Experiment, 3) Journal/Reflection, and 4) dialogic reading centered around a given theme such as plant life. In the control condition, a minimum of six phoneme identifications and five rhymes will be incorporated into each lesson of this curriculum. While these activities are likely to improve the children's awareness of the sounds of the language (a foundational skill for learning to read), they are not likely to improve their access to the science being taught. Therefore, this intervention constitutes a placebo.
Behavioral: Science + Phonological Awareness
The goal is to facilitate phonological awareness during science lessons. Because phonological awareness does not relate to science learning, this is a placebo.

Experimental: Science + Grammar Intervention
In the science + grammar condition, focused stimulation, an intervention commonly used to target expressive language, will be used to treat complement clauses during the FOSS activities. The approach is incidental, rather than explicit. The active ingredients are models and recasts of the target structure. Recasts occur when an examiner responds to a child's naturally occurring utterance by expanding or extending the child's utterance to include a target grammatical structure. Recasts and/or models will be provided at an average rate of one per minute, an accepted therapeutic dose.
Behavioral: Science + Grammar Intervention
The goal is to facilitate science learning by providing models, prompts, and experiences with grammatical structures related to science processes.

Experimental: Science + Vocabulary Intervention
This arm involves Robust Vocabulary Instruction, an explicit approach that emphasizes multiple and rich encounters in authentic contexts to promote depth of semantic knowledge of 20 words that pertain to scientific practices applicable to the FOSS lessons. The children receive a cumulative exposure of at least 20 times per word (a minimum of 5 times per each of four lessons) and at least 4 chances to produce the word (a minimum of 1 chance per each of four lessons).
Behavioral: Science + Vocabulary Intervention
The goal is to facilitate science learning by providing models, prompts, and experiences with vocabulary related to science processes.




Primary Outcome Measures :
  1. Targeted science content outcome [ Time Frame: 1 week ]
    The outcome relevant to aim 1 will be measured with eight 10-item, proximal concept assessments (to cover content taught during the intervention period) and two 10-item proximal assessments (to cover content taught after the intervention has been withdrawn). These will all be administered during the withdrawal week. These will be adapted from the FOSS I-check probes (e.g., Item 1: What is in the night sky? Stars? Sun? Moon?). From these, an accuracy score will result. The investigators will be able to determine whether the children learn more of the target science concepts in the language-supported conditions than in the control arm. Comparison of the performance on these assessments will allow determination of whether any improved access to the curriculum remains after the language supports are withdrawn.


Secondary Outcome Measures :
  1. Generalized Science Concepts and Processes [ Time Frame: eleven weeks ]
    For science concepts and processes, the distal measure is the Lens on Science Assessment (https://ies.ed.gov/ncer/projects/grant.asp?ProgID=7&grantid=805). A score reflecting mastery of science concepts will result. This will be administered to children in all three conditions in the three weeks before intervention and again in the three weeks after withdrawing the language supports in the active conditions.

  2. Generalized Science Practices [ Time Frame: eight weeks ]
    For science practices, the distal measure is the retelling of a Sid the Science Kid episode (http://pbskids.org/sid/). A score reflecting completeness of the retelling will result. This measure will be administered to children in all three conditions in the three weeks before intervention and again immediately after withdrawing the language supports in the active conditions.


Other Outcome Measures:
  1. Language Outcomes-Grammar [ Time Frame: eleven weeks ]
    An investigator-created probe involving 20 complement clause elicitations will be administered to children in all three conditions in the three weeks before intervention and again in the three weeks after the withdrawal week. A score reflecting accuracy of production will result.

  2. Language Outcomes-Vocabulary [ Time Frame: eleven weeks ]
    An investigator-created probe involving 20 vocabulary definition and levels of knowing items will be administered to children in all three conditions in the three weeks before intervention and again in the three weeks after the withdrawal week. A score reflecting depth of knowledge will result.

  3. Language Outcomes-Phonological Awareness [ Time Frame: eleven weeks ]
    The rhyme detection-phoneme matching probes from Gillon (2005) http://www.canterbury.ac.nz/media/documents/education-and-health/gail-gillon---phonological-awareness-resources/assessment/PA-Assessment-probe-instructions-(1).pdf will be administered to children in all three conditions in the three weeks before intervention and again in the three weeks after the withdrawal week. A score reflecting accuracy of phonological awareness will result.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Parent will report child's gender.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 4 and 7 years
  • Not yet begun first grade
  • Speaks English as their primary language
  • Has SLI confirmed by 1) a standard score of 94 or lower on the Structured Photographic Expressive Language Test, 3rd edition (SPELT-III, Dawson, Stout, & Eyer, 2003) OR below a scaled score of 7 on the Diagnostic Evaluation of Language Variance™-Norm Referenced (DELV-NR, Seymour, Roeper, & de Villiers, 2005) syntax subtest; AND 2) performing below age-relevant cutoffs on the Dollaghan and Campbell (1998) Nonword Repetition Task OR enrollment on a clinical caseload.
  • Nonverbal matrices t score of 35 or higher on the Developmental Abilities Scale
  • Passes a pure-tone audiometric screening administered according to the standards of the American Speech-Language-Hearing Association (ASHA, 1997)
  • Can produce simple sentences that contain a subject and a verb.
  • Performs with less than 40% accuracy on expressive probes of complement clauses prior to study onset
  • Performs with less than 40% accuracy on vocabulary definition probes prior to study onset

Exclusion Criteria:

  • Other diagnosed neurodevelopmental disorders (e.g., autism, Down syndrome) via parent report or significant sensory or motor impairments (e.g., severe vision impairment uncorrectable by glasses)
  • Exposure to a language other than English at home or school more than 20% of the time.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438760


Locations
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United States, Delaware
University of Delaware
Newark, Delaware, United States, 19716
Sponsors and Collaborators
Father Flanagan's Boys' Home
University of Delaware
University of Iowa
Investigators
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Principal Investigator: Karla K McGregor, Ph.D. Father Flanagan's Boys' Home
Publications:
American Speech-Language-Hearing Association. (1997). Guidelines for audiologic screening.
Dawson, J., Stout, C., & Eyer, J. (2003). Structured Photographic Expressive Language Test, 3rd edition. DeKalb, IL: Janelle Publications.
Seymour, H. N., Roeper, T., & de Villiers, J. G. (2005). DELV-NR (diagnostic evaluation of language variation) norm-referenced test. San Antonio, TX: The Psychological Corporation.

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Responsible Party: Karla McGregor, Director, Center for Childhood Deafness, Language & Learning, Father Flanagan's Boys' Home
ClinicalTrials.gov Identifier: NCT03438760    
Other Study ID Numbers: 17-07-XP
1748298 ( Other Grant/Funding Number: National Science Foundation )
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The University of Delaware IRB would not approve any of our proposals for safe data sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karla McGregor, Father Flanagan's Boys' Home:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Developmental Language Disorder
Randomized Controlled Trial
Additional relevant MeSH terms:
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Learning Disorders
Language Disorders
Language Development Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders