Language Development DisordersNCT04775199
Improving STEM Outcomes for Young Children With Language Learning Disabilities Via Telehealth
A study testing Language Intervention in people with Language Development Disorders, run by Karla McGregor at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- Language Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2021to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Other diagnosed developmental disorders (e.g., autism, Down syndrome) via parent report
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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:
- 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.
- 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.
- 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.
- 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.
- Conditions
- Language Development Disorders
- Being tested
- Language Intervention
- Keywords
- Language Therapy, Randomized Controlled Trial, Specific Language Impairment, Developmental Language Disorder
- Medical subject headings
- Language Development Disorders, Specific Language Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language InterventionBehavioural
The examiners will target vocabulary and grammar in the context of preschool science instructions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Science + Grammar Intervention | Experimental | 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). Receives: Behavioral: Language Intervention |
| Science + Vocabulary Intervention | Experimental | 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. Receives: Behavioral: Language Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted science content outcomes
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.
Measured: within three weeks following end of instruction
Language Outcomes
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.
Measured: 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 outcomes (1)
Generalized Science Outcomes
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.
Measured: within three weeks following end of instruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start9 Jan 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karla McGregor
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, University of Iowa
- Responsible party
- Sponsor-investigator, Karla McGregor, Father Flanagan's Boys' Home
- Investigators
- Karla K McGregor, Ph.D., Principal investigator, Boystown National Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775199
- Sponsor's protocol ID
- NSF1661166
- Status last verified
- Aug 2023
- First submitted
- 25 Feb 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share de-identified spreadsheets of data (scores on all measures) along with a data dictionary in Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving STEM Outcomes for Young Children With Language Learning Disabilities by Intervening at the Intersection of Language and Scientific Thought: A Telehealth RCT
- ClinicalTrials.gov ID
- NCT04775199
- Acronym / sponsor ID
- NSF1661166
- Conditions
- Language Development Disorders
- Keywords
- Language Therapy, Randomized Controlled Trial, Specific Language Impairment, Developmental Language Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Karla McGregorUniversity, hospital or other
- Collaborators
- University of Delaware, University of Iowa
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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. |
| Science + Grammar Intervention | Experimental | Behavioral: Language InterventionGrammar: 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). |
| Science + Vocabulary Intervention | Experimental | Behavioral: Language InterventionVocabulary: 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Other diagnosed developmental disorders (e.g., autism, Down syndrome) via parent report
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language InterventionThe examiners will target vocabulary and grammar in the context of preschool science instructions. | Behavioural | Science + Grammar Intervention, Science + Vocabulary Intervention |
Primary outcome
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.
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.
1 secondary outcome
Generalized Science Outcomes
Time frame: within three weeks following end of instruction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- a page for families to learn about, enroll in, and access the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will share de-identified spreadsheets of data (scores on all measures) along with a data dictionary in Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla K McGregor, Ph.D. principal investigator
Boystown National Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language Intervention in people with Language Development Disorders, run by Karla McGregor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted science content outcomes (time frame: within three weeks following end of instruction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.