Recruiting

Modeling Verbal Mediation

Sponsor:

MGH Institute of Health Professions

Code:

NCT06880731

Conditions

Developmental Language Disorder

Eligibility Criteria

Sex: All

Age: 8 - 10

Healthy Volunteers: Accepted

Interventions

Modeling with Verbal Mediation

Modeling Only

Study Details

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

Study ID

NCT06880731

Start date

Nov 21, 2025

Status verified date

Dec, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 10

Healthy Volunteers: Accepted

Inclusion criteria (children with developmental language disorder; DLD):

  • 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

Inclusion criteria (children with typical development; TD):

  • 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

Exclusion criteria (DLD \& TD groups):

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Training Arm

Modeling with Verbal Mediation

active comparator: Control Arm

Modeling Only

Interventions

Modeling with Verbal Mediation

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.

Modeling Only

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

Primary outcome measure

  • Relevant Utterance Quantity [ Time Frame: Immediately before, during, and immediately after the intervention ]
  • Accuracy on Switch and Stay Trials [ Time Frame: Pre-intervention and immediately after the intervention ]
  • Reaction Time on Switch and Stay Trials [ Time Frame: Pre-intervention and immediately after the intervention ]
  • Cue-P3 Amplitude for Switch and Stay Trials [ Time Frame: Pre-intervention and immediately after the intervention ]

Central Contacts and Locations

Locations

MGH Institute of Health Professions

Recruiting

Boston, Massachusetts, United States, 02129

Contacts

Principal Investigator:

Lauren S Baron, PhD, CCC-SLP

More Information

Sponsor

MGH Institute of Health Professions

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MGH Institute of Health Professions on 2025-12-15.