OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder

Официальное название

OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial

Обзор

The goal of this observer-blinded randomized controlled clinical trial is to determine the effectiveness of a fully-online, parent-mediated, video-based, self-directed intervention for young children with autism (12-60 months) who have been diagnosed with autism in the last six months. The main question\[s\] it aims to answer are: 1. Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group? 2. Does an online intervention for autistic children result in reduced autism symptoms in children, and decreased stress and increased self-efficacy in parents, compared to a psychoeducational control group? 3. What are the predictors of response to intervention (i.e., child sex and age; initial autism symptoms and adaptive behavior; and parent self-efficacy, stress, and education). Parents will be given six compulsory and eight optional online modules that will teach them skills to use while interacting with their autistic children to improve social and communication behaviours and minimize behaviours that interfere with learning. The comparison group will receive six compulsory and eight optional online modules that will teach them about autism more broadly including diagnostic criteria, symptom profiles across development, etc.

Вмешательства

• Поведенческое OPT-IN
  Parents will be provided with online access to 6 compulsory video-based modules and 8 optional video-based modules. These modules will teach them about child development, behavioural principles, and naturalistic developmental intervention principles. These modules will promote skills that parents can use to increase their child's social and communication behaviours and minimize behaviours that interfere with learning (e.g., temper tantrums).
• Другое Psychoeducational control
  This control intervention will provide parents with 6 compulsory and 8 optional modules that will teach them about autism and its developmental course.

Первичные конечные точки

• Change in Adaptive Behavior [Срок оценки: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

Вторичные конечные точки (4)

• Change in Autism Symptoms [Срок оценки: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
• Change in Parenting Stress [Срок оценки: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
• Change in Parental Self-Efficacy [Срок оценки: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]
• Change in Language [Срок оценки: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)]

Критерии участия

Критерии включения

• Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline

Критерии исключения

• Parent does not speak English well enough to complete questionnaires
• Parent or child has complete vision or hearing loss.
• Parent or child is medically unstable.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06011707 · OPTIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗