Treating Complex Grammar Knowledge Deficits in School-Age Children With Developmental Language Disorder

NCT06911138 | Recruiting

• 2 other identifiers: FY24-3051R01DC021429-01A1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this project is to compare the relative effectiveness of two novel treatments to improve the complex grammar knowledge of school-age (8-11-year-old) children with developmental language disorder (DLD). Treatment 1 is an implicit approach to promoting children's automatic grammar learning and Treatment 2 is a more conventional explicit approach in which participants are taught the rules underlying the grammar. Treatment 1 involves children listening to an examiner produce a target sentence 20 times during each training session while describing a picture. The children will then see a picture and be asked to describe the action taking place. Treatment 2 involves children listening to an examiner describe the action occurring in a picture using a sentence pattern targeted to the child's deficit. The child will then be asked who did the action in the sentence and who received the action, after which the examiner will provide specific feedback about why the child's response was correct or incorrect. The expectation is that over a short period children will begin to use their targeted sentence pattern after hearing the examiner produce it many times. Children will complete four outcome measures (syntactic knowledge, sentence comprehension, sentence chunking, narrative comprehension/ production) prior to treatment, immediately after treatment, and five weeks after treatment. Children will be randomly assigned to one of the two treatments. Both treatments will be delivered 20 times over 10 weeks. The investigators anticipate that the children receiving Treatment 1 will show stronger gains in knowledge across the four outcome measures.

Conditions

Developmental Language Disorders

Keywords

Treatment

Outcome Measures

Primary Outcomes (5)

• Sentence Comprehension

  This measure assesses participants' comprehension of subject-object and passive sentences in a conventional picture pointing task, i.e., listening to a sentence then pointing to an image that best depicts what is stated in the sentence. The dependent variable is percent accuracy (0% - 100%).

  Comprehension is assessed at baseline and twice at post-test, immediately following treatment and up to 5 weeks post-treatment.

• Sentence Priming

  This measure assesses participants' knowledge of subject-object and passive sentence structures using a syntactic priming task (i.e., producing the target structure to describe the action occurring in an imagine after hearing the examiner produce the target structure when describing the action occurring in a "prime" imagine). The dependent variable is percent accuracy in producing the target correctly (0% - 100%).

  Syntactic knowledge is assessed at baseline and twice at post-test, immediately following treatment and up to 5 weeks post-treatment.

• Sentence Chunking

  This measure assesses participants' knowledge of subject-object and passive sentence structures using a sentence production task in which participants imitate a sentence spoken by the examiner. The primary dependent variable is the percent accuracy of word recall for each stimulus sentence (0% - 100%).

  Sentence chunking is assessed at baseline and twice at post-test, immediately following treatment and up to 5 weeks post-treatment.

• Narrative Comprehension/Retell

  This measure assesses participants' ability to generalize the use of a trained sentence-level target (subject-object or passive structure) to the discourse level by comprehending and retelling stories containing a targeted sentence structure. The primary dependent variables are (a) percent questions comprehended correctly in a story (0% - 100%) and (b) percent target sentences produced correctly (0% -100%).

  Narrative comprehension/retell is assessed at baseline and twice at post-test, immediately following treatment and up to 5 weeks post-treatment.

• Working Memory

  This measure assesses participants' working memory capacity/span while performing a cognitive activity, i.e., listening to lists of words and digits presented in random order at different list lengths (2-8 items) and then first recalling the words in serial order followed by the digits in serial order. The primary dependent variable is memory span (1.0 items-8.0 items).

  Working memory is assessed at baseline and twice at post-test, immediately after treatment and up to 5 weeks post-treatment.

Study Arms (4)

Implicit Immediate Treatment

EXPERIMENTAL

This treatment involves providing participants an implicit approach to grammar learning via a syntactic priming paradigm immediately following the completion of the pre-treatment measures.

Behavioral: Behavorial

Implicit Delayed Treatment

EXPERIMENTAL

This treatment involves providing participants an implicit approach to grammar learning via a syntactic priming paradigm 10 weeks following the completion of the pre-treatment measures. This arm allows assessing whether improvement on the outcome measures is due to 10 weeks of treatment or just maturation.

Behavioral: Behavorial

Explicit Immediate Treatment

EXPERIMENTAL

This treatment involves providing participants an explicit approach to grammar learning via conventional teaching of grammatical rules immediately following the completion of the pre-treatment measures.

Behavioral: Behavorial

Explicit Delayed Treatment

EXPERIMENTAL

This treatment involves providing participants an explicit approach to grammar learning via conventional teaching of grammar rules 10 weeks following the completion of the pre-treatment measures. This arm allows assessing whether improvement on the outcome measures is due to 10 weeks of treatment or just maturation.

Behavioral: Behavorial

Interventions

Behavorial BEHAVIORAL

Behavioral intervention that focuses on improving syntactic knowledge.

Explicit Delayed Treatment; Explicit Immediate Treatment; Implicit Delayed Treatment; Implicit Immediate Treatment

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Language impairment: standard score of 34 or lower on the Test of Language and Learning Skills
• Nonverbal IQ: nonverbal quotient of 77 or higher
• Normal range hearing
• Normal or corrected vision
• Native English speaker
• Sentence comprehension screening/sentence chunking screening 50% or lower

You may not qualify if:

• Neurodevelopmental disorder
• Emotional/behavioral disorder
• Frank neurological disorder
• Treatment for complex syntax from outside clinician

Sponsors & Collaborators

• Ohio University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (4)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

Ohio University

Athens, Ohio, 45701, United States

RECRUITING

Utah State University

Logan, Utah, 84322, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jeanette Eckert

CONTACT

740-593-0113; j.eckert@ohio.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For each of Study 1 (Treatment of Object Relative Sentences) and Study 2 (Treatment of Passive Sentences), participants will be assigned to one of four treatment conditions (BUT participants will only be treated for either Object Relative Sentences or Passive Sentences): 1. Immediate Implicit Treatment 2. Delayed Implicit Treatment 3. Immediate Explicit Treatment 4. Delayed Explicit Treatment

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 4, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: April 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available to the public starting 1 year following the completion of the project in April 2029, i.e., May 2030.
• Access Criteria: Study protocols and de-identified project data will be available to anyone in an Open Science Framework repository one year after the completion of the project. The repository will include a detailed user guide, a codebook with univariate statistics for each variable, and study-level metadata. Documentation in the form of .pdf documents will include a description of each task and task instructions. Each study will be assigned a digital object identifier (DOI). These data DOIs will be referenced in any publications to allow the research community easy access to the exact data used in the publication. Monitoring of and compliance with this Data Management and Sharing Plan will be the responsibility of Sarah Schwartz at Utah State University in coordination with professional staff at each site, working under the guidance of the three PIs.

Locations

US (4)