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

NCT04775199 | Completed

• 1 other identifier: NSF1661166
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Language Development Disorders

Keywords

Language Therapy, Randomized Controlled Trial, Specific Language Impairment, Developmental Language Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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in all three conditions within three weeks before intervention and again within three weeks after the intervention is withdrawn.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

  within three weeks following end of instruction

Study Arms (3)

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).

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.

Behavioral: Language Intervention

Interventions

Language Intervention BEHAVIORAL

The examiners will target vocabulary and grammar in the context of preschool science instructions.

Science + Grammar Intervention; Science + Vocabulary Intervention

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karla McGregor: lead
• University of Delaware: collaborator
• University of Iowa: collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Links

• a page for families to learn about, enroll in, and access the study

MeSH Terms

Conditions

Language Development Disorders; Specific Language Disorder

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Learning Disabilities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Karla K McGregor, Ph.D.

  Boystown National Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although it is impossible to mask the assessors of the proximal outcome measures, those assessing the distal outcomes can be masked. Specifically, the people scoring the science exposition (a distal measure of generalized scientific content) will be masked to the treatment arm assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: January 9, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The investigators will share all materials within six months after publishing the outcomes of the RCT.
• Access Criteria: Anyone with an account in Open Science Framework will be able to access shared materials.

Locations

US (1)