OPT-IN: Online Parent Training Intervention for Young Children Diagnosed With Autism Spectrum Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 308
- 主要终点
- Change in Adaptive Behavior
研究概览
简要总结
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:
- Does an online intervention for autistic children result in improved adaptive behaviour, compared to a psychoeducational control group?
- 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?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The students who will be conducting the interviews for the primary objective of the study (using the Vineland Adaptive Behavior Scales, Version 3) will be blind to the treatment arm the family is assigned to.
入排标准
- 年龄范围
- 12 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child diagnosed with Autism or Autism Spectrum Disorder within the last six months at baseline
排除标准
- •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.
结局指标
主要结局
Change in Adaptive Behavior
时间窗: baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention)
Change in Vineland Adaptive Behavior Scales, 3rd Edition Parent interview
次要结局
- Change in Parenting Stress(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))
- Change in Autism Symptoms(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))
- Change in Language(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))
- Change in Parental Self-Efficacy(baseline, post-intervention (6 months past baseline), follow-up (6 months past post-intervention))
研究者
Elizabeth Kelley
Dr. Elizabeth Kelley, PhD, Associate professor of Psychology and Psychiatry and CNS, Queen's University
Queen's University