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Набор по приглашению NCT06805916

Promoting Communication in Minimally Verbal Autistic Children with Social Robot

Без фазы С лечением Autism Spectrum Disorder

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: NAO-Assisted Therapy, Standard therapeutic.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder. Базовые параметры: 4 лет — 12 лет · 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Promoting Communicative Initiative in Minimally Verbal Autistic Children Through Interaction with the Humanoid Social Robot

Обзор

Minimally verbal (MV) children with Autism Spectrum Disorder (ASD) face significant challenges in communication and social interaction, which are fundamental to learning and development. Current therapeutic approaches, such as speech therapy and augmentative communication systems, often have variable efficacy due to engagement and responsiveness challenges. This pilot study investigates using of the humanoid robot NAO as part of a rehabilitative program designed for MV children with ASD. NAO, with its predictable and engaging interaction style, is hypothesized to enhance communicative initiative, expressive communication, and social interaction in this population. The study employs a randomized controlled trial design, assigning participants to either an NAO-assisted intervention group or a control group receiving standard therapy. Outcomes will be assessed using standardized measures of communication, social interaction, and observational data. This research aims to explore the potential of social robots as an innovative tool to addressing the unique needs of MV children with ASD, contributing to the development of effective, accessible therapeutic options that improve their quality of life and that of their families.

Подробное описание

Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social communication and restricted, repetitive patterns of behavior, interests, or activities. Among individuals with ASD, approximately 25-30% are minimally verbal (MV), demonstrating limited verbal or non-verbal communication skills, which poses significant challenges for social interaction and learning. Early diagnosis and tailored therapeutic interventions are crucial for improving long-term outcomes in this population. However, traditional therapies often face limitations, including variability in efficacy and difficulty maintaining engagement among MV children. In recent years, the integration of advanced technologies into therapeutic programs has gained traction as an innovative approach to address communication challenges in ASD. Social robots, such as the humanoid robot NAO, offer unique opportunities to engage children with ASD through consistent and predictable interactions. NAO is equipped with capabilities including speech recognition, gestures, and responses to touch and movement, making it an effective tool for promoting communication and social behaviors. Preliminary studies suggest that social robots can enhance engagement and improve social skills in children with ASD, yet their potential remains underexplored in minimally verbal children. This single-blind, randomized, controlled study aims to evaluate the feasibility and effectiveness of a rehabilitative treatment program integrating the NAO robot for minimally verbal children with ASD. NAO-assisted therapy sessions are designed to promote communicative initiative, expressive language, and social interaction through interactive tasks tailored to each child's needs.

The study's outcomes will be measured using standardized communication assessments, including the Test of Verbalization (TVL), and observational data to evaluate engagement, responsiveness, and frequency of communicative behaviors. By leveraging advanced robotic technology, this study aims to explore new avenues for therapeutic interventions, ultimately contributing to the development of evidence-based strategies that improve the quality of life for minimally verbal children with ASD and their families.

Вмешательства

  • Поведенческое NAO-Assisted Therapy
    The intervention sessions included tasks designed to engage the child in verbal and social interactions, such as naming objects, responding to questions, and performing gestures. The NAO robot provided consistent and predictable feedback, while therapists supported and reinforced appropriate communicative behaviors.
  • Поведенческое Standard therapeutic
    Standard therapeutic approaches included exercises aimed at improving verbal communication and social engagement, such as naming objects, sentence construction, and comprehension tasks. Therapists adapted the intervention to the child's individual communication goals.

Первичные конечные точки

  • Language Development Level Test (TVL) [Срок оценки: T0(baseline)-T1(3months)]
  • The Child Behavior Checklist (CBCL) [Срок оценки: T0(baseline)-T1(3months)]
  • Quality of Life in Autism Questionnaire (QoLA) [Срок оценки: T0(baseline)-T1(3months)]
  • Repetitive Behavior Scale (RBS) [Срок оценки: T0(baseline)-T1(3months)]
  • Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: T0(baseline)-T1(3months)]
  • Conners' Parent Rating Scale (CPRS) [Срок оценки: T0(baseline)-T1(3months)]
  • Mand Requests During Sessions [Срок оценки: During Sessions]

Критерии участия

Критерии включения

  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Minimal verbal communication
  • Age between 4 and 12 years.

Критерии исключения

  • Presence of severe intellectual disability.
  • Diagnosis of neurological disorders other than ASD.
  • Significant medical conditions that could interfere with study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Италия · 1 центр
  • IRCCS Centro Neurolesi Bonino Pulejo — Messina

Публикации

  • Hodges H, Fealko C, Soares N. Autism spectrum disorder: definition, epidemiology, causes, and clinical evaluation. Transl Pediatr. 2020 Feb;9(Suppl 1):S55-S65. doi: 10.21037/tp.2019.09.09. PMID 32206584
  • Rose V, Trembath D, Keen D, Paynter J. The proportion of minimally verbal children with autism spectrum disorder in a community-based early intervention programme. J Intellect Disabil Res. 2016 May;60(5):464-77. doi: 10.1111/jir.12284. PMID 27120989
  • Brignell A, Chenausky KV, Song H, Zhu J, Suo C, Morgan AT. Communication interventions for autism spectrum disorder in minimally verbal children. Cochrane Database Syst Rev. 2018 Nov 5;11(11):CD012324. doi: 10.1002/14651858.CD012324.pub2. PMID 30395694
  • Korneder J, Louie WG, Pawluk CM, Abbas I, Brys M, Rooney F. Robot-mediated interventions for teaching children with ASD: A new intraverbal skill. Assist Technol. 2022 Nov 2;34(6):707-716. doi: 10.1080/10400435.2021.1930284. Epub 2021 May 28. PMID 33983864
  • Salimi Z, Jenabi E, Bashirian S. Are social robots ready yet to be used in care and therapy of autism spectrum disorder: A systematic review of randomized controlled trials. Neurosci Biobehav Rev. 2021 Oct;129:1-16. doi: 10.1016/j.neubiorev.2021.04.009. Epub 2021 Apr 20. PMID 33862066

Идентификаторы

NCT: NCT06805916 · NAO01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗