NCT03438760

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

February 9, 2018

Last Update Submit

September 10, 2020

Conditions

Keywords

Language DisordersCommunication DisordersNeurobehavioral ManifestationsDevelopmental Language DisorderRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Targeted science content outcome

    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the intervention period) and two 10-item proximal assessments (to cover content taught after the intervention has been withdrawn).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.

    1 week

Secondary Outcomes (2)

  • Generalized Science Concepts and Processes

    eleven weeks

  • Generalized Science Practices

    eight weeks

Other Outcomes (3)

  • Language Outcomes-Grammar

    eleven weeks

  • Language Outcomes-Vocabulary

    eleven weeks

  • Language Outcomes-Phonological Awareness

    eleven weeks

Study Arms (3)

Science + Phonological Awareness

PLACEBO COMPARATOR

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

Science + Grammar Intervention

EXPERIMENTAL

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

Science + Vocabulary Intervention

EXPERIMENTAL

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

Interventions

The goal is to facilitate phonological awareness during science lessons. Because phonological awareness does not relate to science learning, this is a placebo.

Science + Phonological Awareness

The goal is to facilitate science learning by providing models, prompts, and experiences with grammatical structures related to science processes.

Science + Grammar Intervention

The goal is to facilitate science learning by providing models, prompts, and experiences with vocabulary related to science processes.

Science + Vocabulary Intervention

Eligibility Criteria

Age4 Years - 7 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParent will report child's gender.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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 Varianceâ„¢-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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (5)

  • American Speech-Language-Hearing Association. (1997). Guidelines for audiologic screening.

    BACKGROUND
  • Dawson, J., Stout, C., & Eyer, J. (2003). Structured Photographic Expressive Language Test, 3rd edition. DeKalb, IL: Janelle Publications.

    BACKGROUND
  • Dollaghan C, Campbell TF. Nonword repetition and child language impairment. J Speech Lang Hear Res. 1998 Oct;41(5):1136-46. doi: 10.1044/jslhr.4105.1136.

    PMID: 9771635BACKGROUND
  • 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.

    BACKGROUND
  • Owen Van Horne AJ, Curran M, Cook SW, Cole R, McGregor KK. Teaching little kids big sentences: A randomized controlled trial showing that children with DLD respond to complex syntax intervention embedded within the context of preschool/kindergarten science instruction. Int J Lang Commun Disord. 2023 Sep-Oct;58(5):1551-1569. doi: 10.1111/1460-6984.12882. Epub 2023 May 2.

MeSH Terms

Conditions

Specific Language DisorderLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsLanguage Development Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Karla K McGregor, Ph.D.

    Father Flanagan's Boys' Home

    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 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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will assigned to one of three groups in parallel for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Childhood Deafness, Language & Learning

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 20, 2018

Study Start

November 3, 2017

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

September 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

The University of Delaware IRB would not approve any of our proposals for safe data sharing.

Locations