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Идёт набор NCT05803343

Evaluating Additive Effects of Including Canines in Regulating Together

Без фазы С лечением Autism Spectrum Disorder Emotion Regulation

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: Regulating Together-Canine, Regulating Together-Standard.
Кому может быть актуально
Состояния в реестре: Autism Spectrum Disorder, Emotion Regulation. Базовые параметры: 8 лет — 15 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

Evaluating Additive Effects of Including Canines in Regulating Together: A Group Treatment to Address Emotion Dysregulation in Youth With Autism Spectrum Disorder

Обзор

The primary objective is to evaluate the potential additive effect of animal-assisted intervention (AAI) on a manualized behavioral treatment targeting emotion dysregulation (ED) in children with autism spectrum disorder (ASD). Aim 1: Evaluate whether Regulating Together-Canine demonstrates earlier and greater improvement in emotion dysregulation than Regulating Together-Standard. Aim 2: Evaluate if Regulating Together-Canine increases child engagement and learning compared to Regulating Together-Standard. Exploratory Aim: Explore association of physiological arousal (via heart rate tracking) with emotion dysregulation, treatment engagement, and learning.

Подробное описание

Children between the ages of 8 years 0 months and 15 years 11 months with Autism Spectrum Disorder (ASD) and emotion dysregulation (ED) and their caregivers will participate in 5 research visits and 10 group intervention sessions. They are randomly assigned to either Regulating Together-Standard group (no dog), or Regulating Together-Canine group (with dog). Characterization measures will be completed at Screen (T1). All outcome measures will be completed at Baseline (T2), Post-treatment (1-2 weeks following treatment completion, T3), 10 week post treatment completion follow up (T4), and 6 month post treatment completion follow up (T5).

Вмешательства

  • Поведенческое Regulating Together-Canine
    RT-C is an animal assisted, intensive outpatient group intervention for children with autism spectrum disorder and emotion dysregulation. RT-C meets for 1.5 hours, twice weekly for five weeks with concurrent youth and caregiver groups. The children progress through skills including relaxation training, arousal ratings, problem size, mindfulness, problem solving, and cognitive flexibility. The caregivers learn crisis management, reward systems, and coaching strategies for topics taught to the chi
  • Поведенческое Regulating Together-Standard
    RT-S an established, intensive outpatient group intervention for children with autism spectrum disorder and emotion dysregulation. It engages both caregivers and children and utilizes evidence-based intervention techniques including cognitive behavioral therapy (CBT), visuals, reinforcements, and scaffolding, and newer interventions such as mindfulness and acceptance-based therapy.

Первичные конечные точки

  • Emotion Dysregulation Inventory-Reactivity (EDI-R) [Срок оценки: Through study completion]

Критерии участия

Критерии включения

  • Concern of emotion dysregulation (ED) as measured by a score of 6 or greater on the Emotion Dysregulation Inventory-Reactivity (EDI-R)
  • Diagnosis of autism spectrum disorder (ASD)
  • Diagnosis confirmed by an experienced ASD clinician and further supported by scoring in the range for ASD on the Autism Diagnostic Observation Schedule (ADOS-2)
  • A Full Scale Intelligence Quotient score of 65 or greater on the Weschler Abbreviated Scale Intelligence (WASI-II)
  • English is the primary language
  • Family willing to keep prescribed medication stable over the course of the study period

Критерии исключения

  • Participant has a phobia toward or is allergic to canines
  • Participant has a history of aggression toward animals
  • Participant has had any physical aggression toward other children outside the home in the past 2 weeks that resulted in injury
  • Presence of comorbid major neuropsychiatric illness warranting other treatment approaches as determined by the study clinician(s) including substance use disorders, psychotic disorders/schizophrenia, and bipolar disorder, among others
  • Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
  • A legal guardian is not available to provide informed consent

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

США · 1 центр
  • Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT05803343 · 1R01HD106353

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗