Improving STEM Outcomes for Young Children With Language Learning Disabilities Via Telehealth

August 10, 2023 updated by: Karla McGregor

Improving STEM Outcomes for Young Children With Language Learning Disabilities by Intervening at the Intersection of Language and Scientific Thought: A Telehealth RCT

In this study the investigators focus on a subset of at-risk students who find the language of science to be a barrier to the learning of science. These are the nearly 3 million children in the U.S. who have a learning disability called specific language impairment (SLI). Children with SLI present with deficits in spoken grammar and vocabulary and they are 3.9 to 8.1 times more likely to have reading deficits than children in the general population.

Specific Aim #1: To determine whether science-relevant language intervention enhances the learning of science concepts in young children who have SLI.

Specific Aim #2: To determine whether science-relevant language intervention facilitates generalization of science concepts and practices in young children who have SLI

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

63 4- to 7-year-olds who have not yet begun 1st grade, who are monolingual speakers of English, and who have SLI will participate. Note that the investigators may recruit extra participants to allow for attrition. The investigators will adopt a Randomized Controlled Trial design, randomly assigning participants into three intervention conditions: science only (the control arm), science + vocabulary supports, and science + grammar supports. Pre- and post-measures will reveal the extent of learning in each condition and comparisons between conditions will reveal whether the grammar and vocabulary supports improved learning.

The hypothesis is that the language and learning of science are integrally related. Therefore, the investigators will use evidenced-based language interventions to improve the children's science-relevant language skills, with the prediction that this will cascade into changes in the acquisition of science concepts and practices:

  1. Children in the science + language intervention conditions will show greater gains in taught science concepts across the 6-week intervention period than children in the control arm.
  2. Children in the science + language intervention conditions will show greater gains from pretest to posttest on measures of generalized science concepts and practice than children in the control arm.
  3. Children who demonstrate the greatest improvement in the use of the language targets will also demonstrate the greatest improvements in taught concepts, generalized concepts, and generalized practice knowledge.
  4. Children will benefit from language supports directed at vocabulary as well as those directed at grammar, but these supports may differently benefit the science learning process.

First the investigators will document that the language supported interventions resulted in improved language abilities by comparing performance on probes of grammar and vocabulary at posttest to pretest performance. The investigators expect significant improvements in vocabulary knowledge for the vocabulary intervention condition as compared to the other two conditions, and significant improvements in use of complement clauses for the grammar intervention condition as compared to the other two conditions. Next, to be tested are the predictions associated with the specific aims via a series of logistic mixed models. Mixed models are appropriate for designs with unbalanced cell sizes due to missing data (due to non-response and dropout). There will be one model for targeted science concept outcomes with condition (control arm, science + vocabulary, science + grammar) and time as independent variables (Predictions 1 and 4). There will also be one model each for generalized concepts and generalized practice outcomes with condition (control arm, science + vocabulary, science + grammar) and time (pretest and posttest) as independent variables (Predictions 2 and 4). Within-subject correlation will be accounted for with random subject intercepts. Additional random effects (including random item intercepts or random condition slopes by item) will be determined by selecting the model with the best model fit (lowest AIC value). In each of the models, it is further expected that amount of improvement in grammar and vocabulary are mediators between the outcome and the other factors (Prediction 3). To assess this prediction, performance on the language probes will be considered as covariates. It is expected that performance on the language probes after instruction will be a significant predictor of science learning, and that including performance on the language probes as a covariate will reduce or eliminate the effect of condition because language performance will be the main factor predicting science performance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Amanda O Van Horne, Ph.D
  • Phone Number: 319-471-0036
  • Email: ajovh@udel.edu

Study Contact Backup

  • Name: Samantha Weatherford, M.A.
  • Phone Number: 302-455-7592
  • Email: slwslp@udel.edu

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19716
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 4 and 7 years
  • Not yet begun first grade
  • Monolingual speaker of English
  • Has SLI confirmed by a standard score of below 85 on the Diagnostic Evaluation of Language Variation-Norm Referenced DELV-NR (Seymour, Roeper, De Villiers, & De Villiers, 2005)
  • Differential Abilities Scale-II (Elliott, 2007) t score greater than or equal to 35
  • Can produce simple sentences
  • Performs with less than 40% accuracy on expressive probes of complement clauses prior to study onset

Exclusion Criteria:

  • Other diagnosed developmental disorders (e.g., autism, Down syndrome) via parent report

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Control: In all conditions, the examiners will teach science using the Full Option Science System Next Generation Edition (FOSS, 2015, https://www.fossweb.com/) curriculum that involves 1) Prediction, 2) Experiment, 3) a visual Journal/Reflection, and 4) a pre-recorded reading centered around a given theme such as sound. A research speech-language pathologist will provide two 30-minute interactive science lessons per week for six weeks to children with language learning challenges recruited nationwide. Children will participate in groups of three. Families will log on five additional times during each week to view the science book reading. In the control condition, children will receive these science lessons but no language intervention. Therefore, this intervention constitutes a nonintervention.
Experimental: Science + Grammar Intervention
Grammar: In the science + grammar condition, focused stimulation plus explicit instruction will be employed. Focused stimulation an intervention commonly used to target expressive language, will be used to treat complement clauses during the FOSS activities.. The active ingredients are models (30) and recasts (5 per child) of the target structure (e.g., "You measured how long the ramp is"). 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. Focused stimulation will be supplemented with explicit instruction using choral production and visual supports (3x per lesson) and a definition of the meaning of the structure (1 per lesson).
Behavioral: Language Intervention
The examiners will target vocabulary and grammar in the context of preschool science instructions.
Experimental: Science + Vocabulary Intervention
Vocabulary: This arm will provide Robust Vocabulary Instruction, an explicit approach that emphasizes multiple and rich encounters in authentic contexts to promote depth of semantic knowledge of 12 words that pertain to scientific practices applicable to the FOSS lessons. The words are: compare, diagram, evidence, explanation, hypothesis, materials, model, multiple, pattern, problem, scientist, search. Two words will be targets in each session. The examiners will ensure that for each target word per session there will be at least one definition model and 3 other models directed to the triad of participants and at least 2 elicitations per child. The recorded books also include 6 additional exposures to the words, for a cumulative exposure of 12.
Behavioral: Language Intervention
The examiners will target vocabulary and grammar in the context of preschool science instructions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Targeted science content outcomes
Time Frame: within three weeks following end of instruction
To measure outcomes relevant to aim 1, the examiner will administer three 10-item, proximal concept assessments one for each science unit at the end of all instruction. These will be adapted from the FOSS I-check probes (e.g., What would you see in the night sky? Stars? Sun? Moon?). From these, 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.
within three weeks following end of instruction
Language Outcomes
Time Frame: These two assessments will be administered to children in all three conditions within three weeks before intervention and again within three weeks after the intervention is withdrawn.
The examiner will administer two proximal, investigator-created probes for language: 1) 20 complement clause elicitations; and 2) 20 vocabulary items (12 that were taught and 8 foils) will be tested for receptive knowledge in a 3-alternative -forced choice format.
These two assessments will be administered to children in all three conditions within three weeks before intervention and again within three weeks after the intervention is withdrawn.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Generalized Science Outcomes
Time Frame: within three weeks following end of instruction
To measure outcomes relevant to aim 2, the examiner will administer a distal measure of generalized science knowledge. For science concepts, the distal measure is science exposition retell task adapted from Panayota Mantzicopoulos & Helen Patrick (2010) "The Seesaw Is a Machine That Goes Up and Down": Young Children's Narrative Responses to Science-Related Informational Text, EARLY EDUCATION AND DEVELOPMENT, 21:3, 412-444, DOI:10.1080/10409281003701994 The child listens to a series of one-paragraph-long descriptions of a science or engineering construct (e.g., levers) and retells each to the examiner. The retells are scored for the scientific themes and linguistic content included. This task will be administered to children in all three conditions within three weeks before intervention and again within three weeks after withdrawing the language intervention.
within three weeks following end of instruction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karla McGregor

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Iowa
University of Delaware

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karla K McGregor, Ph.D., Boystown National Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSF1661166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will share de-identified spreadsheets of data (scores on all measures) along with a data dictionary in Open Science Framework.

IPD Sharing Time Frame

The investigators will share all materials within six months after publishing the outcomes of the RCT.

IPD Sharing Access Criteria

Anyone with an account in Open Science Framework will be able to access shared materials.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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