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Идёт набор NCT05987761

PRT for Adolescents With High Functioning Autism

Без фазы С лечением Autism Autism Spectrum Disorder High-Functioning Developmental Disability Child 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: PRT for Adolescents.
Кому может быть актуально
Состояния в реестре: Autism, Autism Spectrum Disorder High-Functioning, Developmental Disability, Child Development. Базовые параметры: 11 лет — 14 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
США
Следующий шаг
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Официальное название

Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study

Обзор

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

Вмешательства

  • Поведенческое PRT for Adolescents
    Clinician-led 70-minute PRT sessions targeting social skills once per week at Stanford.

Первичные конечные точки

  • (Target) Change from baseline (Pre-training) in brain connectivity between superior temporal sulcus (STS) and the nucleus accumbens (NAc) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • Change from baseline (Pre-training) in structured laboratory observations (SLO) of child-assessor interactions [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
Вторичные конечные точки (6)
  • Change in the Social Communication subscale of the Brief Observation of Social Communication Change (BOSCC) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • (Secondary target) Change in brain connectivity between superior temporal sulcus (STS) and temporoparietal junction (TPJ) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • Association between change in target engagement and change in clinical benefit (STS and NAc) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • Association between change in target engagement and change in clinical benefit (STS and TPJ) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • Group differences in the association between change in target engagement and clinical benefit (STS and NAc) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]
  • Group differences in the association between change in target engagement and clinical benefit (STS and TPJ) [Срок оценки: Pre-treatment baseline, and between 11 to 13 weeks post-baseline]

Критерии участия

Критерии включения

  • Clinical Diagnosis of Autism Spectrum Disorder, higher functioning/low support needs
  • Intelligence Quotient (IQ): Participants with a Full Scale IQ > 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)
  • Right-handed
  • No metal in their body/unremovable metal on their body (i.e., braces)
  • First language is English
  • Must live in the San Francisco Bay Area
  • Able and willing to receive intervention weekly for 9 weeks
  • Adolescent is interested in improving their social skills
  • MRI Compatibility: No major contraindication for MRI.
  • Diagnosis of ASD using ADOS-2 and ADI-R.
  • No evidence of a genetic, metabolic, or infectious etiology for their autism.
  • Primary diagnosis of ASD
  • No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.
  • Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation.
  • Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)
  • No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.

Критерии исключения

  • History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and/or gestational age < 34 weeks
  • Left-handed
  • Braces or any metal in their body

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Stanford Research Park — Palo Alto

Идентификаторы

NCT: NCT05987761 · 60502

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗