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临床试验/NCT04992169
NCT04992169已完成不适用

Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program

University of California, Santa Barbara2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年8月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change from Baseline in Parent Fidelity of Implementation of Pivotal Response Treatment (PRT) during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks

研究概览

简要总结

This project will examine the feasibility, acceptability, and preliminary efficacy of using a smartphone app-based parent training program focused on early autism intervention strategies.

详细描述

Despite scientific advances in treatment for autism spectrum disorder (ASD), most families across the United States do not have access to high quality autism services, let alone the best autism treatment models available. There are a number of reasons for this concerning reality, including the limited number of trained autism clinicians around the country, the rising cost of services, geographic distance from autism service providers, and difficulties in being able to effectively and efficiently train a large number of people in the latest treatment models.

This proposed project focuses on the Department of Defense Autism Research Program - Clinical Translational Research Award Area of Interests focused on Dissemination/Implementation of Clinically Validated Interventions and Behavioral Therapies for ASD Core Symptoms. These areas focus on effective strategies for taking what works (in this case, highly effective autism treatments shown to improve social communication and motivation in children with autism) and spreading or distributing these treatments so that they can benefit a much larger portion of the population. This is important, because a highly effective treatment is of little use if only people in a few areas can benefit from its effect, while the rest of the nation continues to use outdated, less effective strategies.

To accomplish the goal of distributing a highly effective intervention to the general public, this proposed study will take advantage of the wide-spread use of smartphones nationwide. This study proposes to develop and evaluate smartphone apps as a way to train parents of young children with ASD in an autism treatment model known as Pivotal Response Treatment (PRT). Families will be recruited nationwide to participate in this trial.

Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with ASD. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes. After each lesson, parents will be asked to record a brief video of themselves using PRT with their child, which is submitted within the app to the research team so that they can monitor their mastery of the strategies over time. The investigators will also ask parents to complete autism-related and developmental surveys before and after participation so that the research team can monitor how their child is improving.

Ultimately, the objective of this trial is to develop and test smartphone apps to deliver a highly effective autism intervention to families nationwide. The use of this technology will ensure that families can access gold standard autism treatment regardless of their geographic location, work schedules, or financial background. If successful, the investigators plan to conduct an even larger nationwide study and ultimately make the app available in smartphone app stores so that families everywhere can train themselves in this treatment approach.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participant families will be randomly assigned by the smartphone app to one arm or the other. While caregivers are not directly notified of their group/arm assignment, their participation in arm-specific app-tasks may help them determine which arm they are assigned to. Investigators and outcomes assessors remain masked to condition until data collection and analysis is completed.

入排标准

年龄范围
12 Months 至 54 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of autism spectrum disorder
  • Parent endorsements of significant language delay
  • Between the ages of 1.0 and 4.5 years (12 and 54 months)
  • Parents willing to complete intake and follow-up assessments, complete the eight weekly PRT lessons, record and submit parent-child PRT videos, and review these videos on a weekly basis.
  • Access to an internet connection and an iOS smartphone or tablet that can supports the app and records video.

排除标准

  • Significant medical conditions, seizures, and mental health concerns
  • Non-English speaking
  • Prior parent training in PRT or similar Naturalistic Developmental Behavioral Intervention

结局指标

主要结局

Change from Baseline in Parent Fidelity of Implementation of Pivotal Response Treatment (PRT) during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks

时间窗: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)

Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a trial-by-trial basis for the presence or absence of each PRT intervention component, which include the use of: child choice, child attention, clear opportunities, contingent reinforcement, reinforcement of child response attempts, a balance of maintenance and acquisition tasks, and task variation. Total uses of these components will be divided by total uses + absences of these components to yield a percentage. The mean percentage of all components will be used as the primary outcome, with a range of 0% to 100% use of the PRT components.

次要结局

  • Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.(Baseline, 8 weeks (intervention completion), 16 weeks (follow-up))
  • Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks(Baseline, 16 weeks (follow-up))
  • Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks(Baseline, 16 weeks (follow-up))
  • Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.(Baseline, 8 weeks (intervention completion), 16 weeks (follow-up))
  • Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks(Baseline, 16 weeks (follow-up))
  • Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks(Baseline, 16 weeks (follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ty Vernon

Associate Professor

University of California, Santa Barbara

研究点 (2)

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