跳至主要内容
临床试验/NCT06880731
NCT06880731招募中不适用

Training Verbal Mediation to Support Executive Function in Children With Developmental Language Disorder

MGH Institute of Health Professions1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
Relevant Utterance Quantity

研究概览

简要总结

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.

详细描述

This project aims to determine the impact of modeling verbal mediation on the executive function (EF) of shifting in school-aged children with DLD. The investigators will determine the effect of modeling verbal mediation on the use of verbal mediation (Aim 1) and behavioral and electrophysiological measures of shifting (Aim 2). Because accuracy and reaction time are not direct measures of the cognitive process that leads to shifting, they will be supplemented with an electrophysiological marker of shifting that reflects real-time cue processing.

PARTICIPANTS: Seventy-five children (N = 75) aged 8 to 10 years will be enrolled in this study over the course of three years. Target enrollment is 25 children in each group (DLD-training, DLD-control, TD-control) matched on age (+/- 3 months) and gender. Over-recruitment of 85 total participants accounts for up to 14 percent attrition due to excessive artifacts in the EEG recording such as excessive eye blinks and/or movements (estimated at 10 percent), or a participants failure to complete all study tasks and tests (estimated at 4 percent). It is important to note that the project is based on a system for EEG recording that is optimized for use with children, and that the PI has used this system to study children in this age range with minimal loss of data due to artifacts. See the EEG data acquisition and processing sections for details.

Age Justification: This age group was selected because (1) children have made substantial development in spoken language and EF by this time, (2) the early school years are considered a key period in development as children are faced with external challenges that require them to use language and executive skills efficiently, and (3) evidence exists that this age range marks a period with extensive use of verbal mediation to support EF task performance.

GENERAL STUDY PROCEDURE: The study will involve (a) standardized assessments of language and cognitive skills described below and (b) an experimental protocol including three phases: pre-intervention, intervention, and post-intervention. Each phase will require 1 visit to the research lab, with 1-2 weeks between each phase, and a desired timeframe between pre- and post-intervention sessions of 14-21 days.

  • Classification to DLD and TD Groups: Children with DLD will have a history of delayed language development as reported by a caregiver during an initial phone screening and will meet the criteria for DLD as determined by administration of standardized assessments of language and cognitive skills. Children will be confirmed as having DLD if they obtain an Identification Core Score (ICS) of less than 34 on the Test of Integrated Language and Literacy Skills (TILLS). Children with TD will not have a history of delayed language development and they will obtain a score of 34 or higher on the TILLS. All children must obtain a standard score greater than 70 on the Fluid Subtest of the Kaufman Brief Intelligence Test, 2nd edition (KBIT-2) to exclude those with cognitive impairments.
  • Assignment to Training or Control Conditions: The study is an individually randomized trial with a parallel intervention design. All TD participants will complete the control condition. DLD participants will be randomly assigned to either the training or control condition. Randomization will occur after confirming classification to the DLD group and before beginning the intervention phase of the experimental protocol. The PI will oversee a block randomization protocol to assign participant IDs to either the training or control condition. Distinct teams of research assistants (RAs) will be trained to (A) conduct pre- and post-intervention sessions, (B) conduct intervention sessions, and (C) code verbal mediation data collected during the intervention session. The PI will inform members of Team B about participant assignments using controlled access features of the REDCap database. Teams A and C will be blinded as to whether children with DLD were in the training or control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •(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

排除标准

  • •(DLD & TD groups):
  • •KBIT-2 Fluid Subtest Standard Score < 70
  • •ADHD, Autism, TBI, or other neurological deficits or disorders

研究组 & 干预措施

Control Arm

Active Comparator

Modeling Only

干预措施: Modeling Only (Behavioral)

Training Arm

Experimental

Modeling with Verbal Mediation

干预措施: Modeling with Verbal Mediation (Behavioral)

结局指标

主要结局

Relevant Utterance Quantity

时间窗: Immediately before, during, and immediately after the intervention

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

Accuracy on Switch and Stay Trials

时间窗: Pre-intervention and immediately after the intervention

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.

Reaction Time on Switch and Stay Trials

时间窗: Pre-intervention and immediately after the intervention

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.

Cue-P3 Amplitude for Switch and Stay Trials

时间窗: Pre-intervention and immediately after the intervention

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.

次要结局

未报告次要终点

研究者

发起方
MGH Institute of Health Professions
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lauren S. Baron

Postdoctoral Research Fellow

MGH Institute of Health Professions

研究点 (1)

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