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临床试验/NCT05948202
NCT05948202已完成不适用

Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial

Virginia Polytechnic Institute and State University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年4月10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
15
试验地点
2
主要终点
Therapist fidelity observation

研究概览

简要总结

This project tests the feasibility and preliminary proof of concept for a mindfulness-enhanced adaptation of Pivotal Response Treatment on parenting stress and child communication, using a randomized controlled design.

详细描述

One of the core features of Autism Spectrum Disorder (ASD), social communication impairment, presents in a variety of ways, including reduced functional language use and social initiations, which often warrant intensive intervention services. Additionally, parents of children with ASD demonstrate increased levels of parenting stress when compared to parents of typically developing children and children with developmental delays. Elevated parenting stress has been shown to diminish positive treatment outcomes, which lends support to develop methodologies to concomitantly target child and parent behaviors. The current randomized control trial (RCT) uses a dual-pronged approach to directly target both child communication deficits and parenting stress within a group format. This RCT combined an empirically supported behavioral therapy, Pivotal Response Treatment (PRT), with components from Acceptance and Commitment Therapy and Mindful Parenting for reducing parenting stress. Caregivers and their minimally or pre-verbal child with diagnosed or suspected ASD were randomly assigned to one of the following supplemental conditions: mindfulness-enhanced PRT (mPRT) or psychoeducation-enhanced PRT (pPRT) as an active control condition. The current study assessed feasibility and acceptability in addition to demonstrating proof of concept in regard to additive effects of mPRT compared to pPRT.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • For children: minimally verbal or nonverbal, 1.5 to 6 years old, current or suspected autism spectrum disorder diagnosis, demonstrated ability to make meaningful vocalizations
  • For parents: willingness to attend group treatment sessions, record weekly videos, and share videos in a group setting

排除标准

  • For children, no active medical problems (e.g., unstable seizure disorders)
  • For parents, no severe mental health problems (e.g., suicidal intent, psychosis)

结局指标

主要结局

Therapist fidelity observation

时间窗: weekly, from start of treatment through 12 weeks

observation at 30-second intervals; number out of 10 pivotal response therapy components observed for each 30-second interval of the recording and then averaged over the length of the recording (which were 5-10 minutes long)

Child utterances - observation

时间窗: follow-up, at 3 months after the last treatment session

level or amount of child utterances during a structured laboratory task observation

Parent fidelity observation

时间窗: weekly, from start of treatment through 12 weeks

observation at 30-second intervals; number out of 10 pivotal response therapy components observed for each 30-second interval of the recording and then averaged over the length of the recording (which were 5-10 minutes long)

Parenting Stress Index, 4th edition

时间窗: follow-up, at 3 months after last treatment session

level of parent-reported stress

Autism Parenting Stress Index

时间窗: follow-up, at 3 months after last treatment session

level of parent-reported stress specific for parents of young autistic children

Subjective Units of Parenting Stress Scale

时间窗: follow-up, at 3 months after last treatment session

level of parent-reported stress immediately following the structured lab observation

次要结局

  • Parent Feelings Questionnaire(follow-up, at 3 months after last treatment session)
  • Five Facet Mindfulness Questionnaire(follow-up, at 3 months after last treatment session)
  • Positive and Negative Affect Schedule(follow-up, at 3 months after last treatment session)
  • Acceptance and Action Questionnaire(pre-treatment, at intake)
  • Child Behavior Checklist for ages 1.5 to 5(follow-up, at 3 months after last treatment session)

研究者

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

Angela Scarpa-Friedman

Professor

Virginia Polytechnic Institute and State University

研究点 (2)

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