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
|Condition or disease||Intervention/treatment||Phase|
|Specific Language Impairment||Behavioral: Science + Phonological Awareness Behavioral: Science + Grammar Intervention Behavioral: Science + Vocabulary Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, Delaware|
|University of Delaware|
|Newark, Delaware, United States, 19716|
|Principal Investigator:||Karla K McGregor, Ph.D.||Father Flanagan's Boys' Home|