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Идёт набор NCT06156865

Using Neuroimaging and Behavioral Assessments to Understand Late Talking

Без фазы С лечением Developmental Language Disorder Language Delay Language Development

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intervention to address late talking.
Кому может быть актуально
Состояния в реестре: Developmental Language Disorder, Language Delay, Language Development. Базовые параметры: 18 мес. — 30 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Neuroimaging Reveals Treatment-related Changes in DLD: A Randomized Controlled Trial (Supplement)

Обзор

Late talkers (LT), representing 10-20% of children under 3, demonstrate hallmark syntax and vocabulary deficits similar to preschoolers with developmental language disorder. While effective and early interventions can mitigate the impact of late talking, not enough is known about its neural basis, yet is needed to inform the design of more individualized interventions. This proposed effort uses neuroimaging, along with behavioral methods, with the goal of better understanding the memory-language mechanisms that underlie learning and late talking, while also considering their association to treatment-related changes in LT.

Подробное описание

Late talking represents one of the most common reasons children under 3-years of age are referred for speech-language evaluations, impacting about 10%-20% of children in this age-group. Late talkers (LT) also share similarities with children diagnosed with developmental language disorder (DLD) at 4 - 5 years of age, endorsing the notion that shared neurobiological underpinnings might exist between these two clinical groups. However, little is known about the neural basis of late talking, yet is needed to better inform the design of efficacious therapies that address hallmark delays in syntax and vocabulary. For the DLD population, domain-general processes relating memory and language are being investigated in the parent grant, offering valuable testing ground for also advancing the current knowledge base regarding LT. The Procedural circuit Deficit Hypothesis (PDH) posits that relative strengths and weaknesses exist between procedural (impaired) and declarative (less impaired) memory systems. Structural abnormalities in connections between frontal brain regions and basal ganglia, with under activation and reduced connectivity also evident. However, cortical and subcortical regions in the temporal lobes, including hippocampus, might be impaired to a lesser degree.

This proposed research will use diffusion imaging to describe the neural basis (structural connectivity) of late talking and treatment-related change by way of the PDH. The investigators will gather data regarding LT before, after, and following a break in standard intervention for LT (e.g., parent coaching, direct therapy for children who are LT): LT treatment. The investigators will also include a "business as usual": LT no treatment as part of a highly feasible pragmatic design that leverages existing pipelines. The investigators will also include typically developing (TD) peers to inform development vs late talking. The central hypothesis is that treatment designed to improve syntax and vocabulary will change procedural and declarative networks in association with increases in language function and the degree of improvement may be associated with the underlying neurobiology of baseline syntax and vocabulary deficits.

Building on a robust history of recruitment and treatment of toddlers by the investigators' partnering sites, and the investigators' successful imaging partner, this project will enroll 30 LT (n=15 treatment; n=15 controls) and 15 TD peers. Aim 1 will establish the structural connectivity in LT and their TD peers between regions in the procedural learning and declarative networks. In Aim 2, the investigators will establish the neurobiological basis of treatment-related changes in LT only. The investigators examine potential changes in structural connectivity between regions of the procedural learning and declarative memory networks, and investigate whether treatment-related changes occur into the typical range (LT, TD). To meet the scientific goals, the investigators pair behavioral tools (syntax and vocabulary) with neuroimaging to describe co-occurring behavioral performance underlying learning and outcome, while also gathering parental and clinician qualitative data regarding treatment outcomes. This research will contribute novel insights into mechanisms underlying learning and impairment to offer a ground-breaking shift in the understanding of LT.

Вмешательства

  • Поведенческое Intervention to address late talking
    this intervention is designed to support both speech and language development in children who are toddlers. Given the age group of children their parents are part of the intervention program. Importantly the frequency of the intervention can range from once to twice per week, with timing also designed to complement the particular agency

Первичные конечные точки

  • Aim 1/Pre - Structural connectivity data using diffusion imaging [Срок оценки: Weeks 1 to 2 (Time 1/pre)]
  • Aim 2/Pre - Changes in structural connectivity data using diffusion imaging [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
Вторичные конечные точки (12)
  • Aim 1/Pre - Raw score on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set) [Срок оценки: Weeks 1 to 2 (Time 1/pre - first set)]
  • Aim 1 - Raw score on the Focus on the Outcomes of Communication Under Six Parent Version- (second set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - second set)]
  • Aim 1/Pre - Raw score on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - third set)]
  • Aim 1/Pre - Raw score on the Intelligibility in Context Scale- (fourth set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - fourth set)]
  • Aim 1/Pre - Raw score on the Communication Function Classification System- (fifth set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - fifth set)]
  • Aim 1/Pre - Raw score calculated using a Consonant Inventory- (sixth set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - sixth set)]
  • Aim 1/Pre - Raw score calculated using a Play-based language sample- (seventh set) [Срок оценки: Weeks 1 to 2 - (Time 1/pre - seventh set)]
  • Aim 2 - Changes in structural connectivity data using diffusion imaging for late talkers only [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the MacArthur Bates Communicative Development Inventories: Words and Sentences- (first set) [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Parent Version- (second set) [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Focus on the Outcomes of Communication Under Six Clinician Version- (third set) [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]
  • Aim 2 - Raw score changes on the Intelligibility in Context Scale- (fourth set) [Срок оценки: Weeks 1 to 8 or 9 (pre to post); Weeks 10 to 17 or 18 (post to followup)]

Критерии участия

Критерии включения

  • child and parent are monolingual/native (primarily) English speakers
  • child is enrolled at one of the participating facilities
  • child is recruited via word of mouth, including social media
  • child is between 18 and 30 months of age
  • child does not have any contraindications to magnetic resonance imaging (i.e., intracranial metal implants, claustrophobia)
  • child does not have any uncorrected vision challenges

Критерии исключения

  • Child does not meet criteria for LT or typical development
  • Standard magnetic resonance imaging exclusion criteria
  • Gestational age less than 37 weeks or greater than 42 weeks
  • Special education placement of child based on ability or behavior

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Канада · 2 центра
  • Grandview Kids — Oshawa
  • Speech Specialists — Toronto

Идентификаторы

NCT: NCT06156865 · 3R01DC019337-04S1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗