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Optimizing Outcomes for Young Autistic Children

Фаза II С лечением Autism 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: Social Communication, Disruptive Behavior, Social Communication + Reduce Frequency, Social Communication + Add Tools.
Кому может быть актуально
Состояния в реестре: Autism, Autism Spectrum Disorder. Базовые параметры: 18 мес. — 48 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Optimizing Outcomes Through Sequencing Parent-Mediated Interventions for Young Children With Autism

Обзор

The overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: a social communication intervention (Project ImPACT, Improving Parents as Communication Teachers) and a disruptive behavior intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes.

Подробное описание

Despite advances in early identification of and intervention for children with autism spectrum disorders (ASD), the long-term outcomes for children with ASD remain variable. As many as 40% of children with ASD are minimally verbal at 9 years of age, and 75% of adults with ASD have persistent social communication (SC) difficulties. Furthermore, as many as 70% of children with ASD have a co-occurring diagnosis of disruptive behavior (DB) disorder. Parents play an important role in SC development and in the prevention of and intervention for DB. As such, the overarching goal of the proposed study is to: (a) determine how best to sequence two parent-mediated interventions: an SC intervention (Project ImPACT, Improving Parents as Communication Teachers) and a DB intervention (Parent Training for Disruptive Behavior) and (b) examine moderators and mediators of intervention outcomes. While evidence of efficacy and feasibility exist for both of these interventions individually, an adaptive intervention approach that considers and optimizes both interventions has not been evaluated. This type of adaptive intervention approach may be particularly needed in parent-mediated interventions due to the cost, burden, and complexity of teaching parents to use multiple intervention strategies. To determine the optimal intervention sequence that considers parent moderators and parent use of intervention strategies, the investigators propose a sequential, multiple assignment, randomized trial (SMART) design in which the investigators will initially randomly assign 184 children with ASD, between 18 and 48 months of age, to receive either the SC or DB intervention. Following each respective manualized, 12-week intervention (first-stage intervention; SC or DB), the interventionist will measure the parents' use of intervention strategies. At this point, all parents will be re-randomized before starting the second-stage intervention. Second-stage intervention decisions are designed to be responsive to parents' implementation of the first-stage intervention strategies. That is, parents who are implementing the first-stage intervention strategies with high fidelity (high implementers) will be re-randomized to receive the same intervention at a lower frequency (Reduce) or to receive the other intervention (Switch). Parents who are implementing the first-stage intervention strategies with low fidelity (low implementers) will be re-randomized to receive the same intervention with an additional parent instructional method, such as video feedback (Augment) or to receive the other intervention (Switch). After 24 weeks of intervention (12 weeks for first stage, 12 weeks for second stage), the investigators will assess child SC skills, child DB, and family life participation in everyday activities. The investigators will also measure parent-child joint engagement continually during intervention to examine the extent to which joint engagement mediates intervention outcomes. The proposed research is significant because if an intervention for one domain (SC or DB) has an impact on the other, an intervention sequence that systematically includes both interventions may have an even greater impact on both domains.

Вмешательства

  • Поведенческое Social Communication
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
  • Поведенческое Disruptive Behavior
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week
  • Поведенческое Social Communication + Reduce Frequency
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour once/week
  • Поведенческое Social Communication + Add Tools
    Intervention: Social Communication Who: Parent \& Child \& Therapist Frequency: 1-hour twice/week
  • Поведенческое Disruptive Behavior + Reduce Frequency
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour every other week
  • Поведенческое Disruptive Behavior + Add Tools
    Intervention: Disruptive Behavior Who: Parent \& Therapist only Frequency: 1-hour once/week

Первичные конечные точки

  • Observed Child Social Communication [Срок оценки: Between 25-30 weeks]
  • Observed Child Disruptive Behavior [Срок оценки: Between 25-30 weeks]
  • Caregiver Report of Child Social Communication [Срок оценки: Between 25-30 weeks]
  • Caregiver Report of Child Disruptive Behavior [Срок оценки: Between 25-30 weeks]
  • Family Life Impairment Scale [Срок оценки: Between 25-30 weeks]
Вторичные конечные точки (2)
  • Caregiver Satisfaction [Срок оценки: Between 25-30 weeks]
  • Caregiver Perceived Stress [Срок оценки: Between 25-30 weeks]

Критерии участия

Критерии включения

  • Child is between 18 and 48 months old
  • Child scores above the research cutoff for ASD on the TELE-ASD-PEDS
  • Child has no other known diagnosis or disability at study entry
  • Child has normal vision
  • Child is exposed to English at least 50% of the time
  • Child has a caregiver willing to learn the intervention strategies
  • Caregiver wants help supporting their child's social communication and behavior regulation
  • Caregiver understands conversational English well enough to participate in caregiver instruction

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Northwestern University — Evanston

Идентификаторы

NCT: NCT05926687 · STU00216950

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗