Training Inner Speech in Children With Developmental Language Disorder

NCT06880731 | Recruiting

• 2 other identifiers: 2025P000464R21DC022641
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The complex and unclear relationship between language and executive function (EF) creates barriers to developing effective interventions for children with developmental language disorder (DLD) whose language difficulties often co-occur with impaired EF. Children and adults with typical language development (TD) facilitate their EF by using self-directed language, or verbal mediation, to guide conscious reflection and override habitual behaviors. Conversely, children with DLD do not use verbal mediation to support EF efficiently or effectively. Promising evidence suggests that language-based training can shape verbal mediation and improve EF task performance in children with TD, which makes it pertinent to determine whether verbal mediation training benefits children with DLD. Specifically, modeling interventions have been shown to promote learning of language forms without taxing the cognitive resources required for learning such as attention or working memory, which are known to be impaired among children with DLD. The long-term goal of the proposed work is to optimize intervention outcomes for children with DLD by elucidating the complex relationship between language and executive functions. The objective of this project is to determine the impact of modeling verbal mediation on shifting task performance in school-aged children with DLD. Shifting, also known as cognitive flexibility, is the ability to alternate between operations or mental sets. It is an important EF because it is the pivot point between multiple goal-directed tasks when language use is critical for guiding action. Children aged 8-10 years will complete three versions of a shifting task over three phases: pre-intervention, intervention, and post-intervention. During the intervention phase, half of the participants with DLD will be exposed to a task model with verbal mediation (training), while the other half will be exposed to a silent task model (control). The investigators will determine the effect of modeling verbal mediation on the subsequent use of verbal mediation (Aim 1) and behavioral and electrophysiological measures of shifting ability (Aim 2). Indirect measures of shifting (i.e., accuracy and reaction time) will be supplemented with an electrophysiological marker of shifting that reflects real-time cue processing. This combination of methods provides insight to changes in processing following intervention that may precede and predict subsequent changes in behaviors. Our central hypothesis is that modeling verbal mediation will facilitate more effective use of verbal mediation and improve shift cue processing in children with DLD. The project will provide a theoretical framework for the role of language in shaping goal-directed behavior and the first examination of electrophysiological change in shifting following a verbal mediation intervention. Results will have a significant impact on clinical practice by advancing knowledge about a promising language-based intervention to support EF and other goal-directed tasks.

Conditions

Developmental Language Disorder

Outcome Measures

Primary Outcomes (4)

• Relevant Utterance Quantity

  The number of relevant utterances (units of speech with no temporal or semantic discontinuities).

  Immediately before, during, and immediately after the intervention

• Accuracy on Switch and Stay Trials

  Accuracy (percent correct) on switch and stay trials during shifting blocks. This measure will be used to evaluate differential accuracy for switch and stay trials before and after intervention.

  Pre-intervention and immediately after the intervention

• Reaction Time on Switch and Stay Trials

  Reaction time (in milliseconds) on switch and stay trials during shifting blocks. This measure will be used to evaluate differential response times during switch and stay trials before and after intervention.

  Pre-intervention and immediately after the intervention

• Cue-P3 Amplitude for Switch and Stay Trials

  The amplitude (in microvolts) of the Cue-P3 event-related potential in response to switch and stay trials during shifting blocks. This measure will be used to evaluate the change in neurophysiological response to visual switch and stay cues before and after intervention.

  Pre-intervention and immediately after the intervention

Study Arms (2)

Training Arm

EXPERIMENTAL

Modeling with Verbal Mediation

Behavioral: Modeling with Verbal Mediation

Control Arm

ACTIVE COMPARATOR

Modeling Only

Behavioral: Modeling Only

Interventions

Modeling with Verbal Mediation BEHAVIORAL

Children will watch and listen as a friendly animated character completes shifting task trials while narrating his thoughts and actions, providing a model of verbal mediation.

Training Arm

Modeling Only BEHAVIORAL

Children will watch as a friendly animated character completes shifting task trials.

Control Arm

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 8;0-9;11 years English as the primary language
• Pass hearing screen bilaterally (20 dB HL, at 1K, 2K, \& 4K)
• TILLS Identification Core Score \< 34
• Age 8;0-9;11 years English as the primary language
• Pass hearing screen bilaterally (20 dB HL, at 1K, 2K, \& 4K)
• TILLS Identification Core Score \> or = 34

You may not qualify if:

• KBIT-2 Fluid Subtest Standard Score \< 70
• ADHD, Autism, TBI, or other neurological deficits or disorders

Sponsors & Collaborators

• MGH Institute of Health Professions: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: November 21, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)