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临床试验/NCT03537261
NCT03537261已完成不适用

Crisis Prevention Institute (CPI) Verbal and Physical Management Training for Parents of Children With ASD (P-CPI)

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2018年8月8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
81
试验地点
2
主要终点
Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score

研究概览

简要总结

The purpose of this 24-week study is to determine whether the "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) is effective in increasing self-efficacy in parents of children with autism spectrum disorder (ASD).

详细描述

Parents of children with ASD deal with more stress, especially if their child demonstrates self-injurious and aggressive behavior. The purpose of this study is to evaluate whether "Parent-based Crisis Prevention Institute (CPI) physical management training program" (i.e., P-CPI) for parents of children with ASD helps alleviate some of this stress and increase parental self-efficacy, physical management competency, and overall quality of life.

Participants who meet criteria will be randomly assigned to either the treatment group or the waitlist control group. Participants assigned to the treatment group will be invited to a 6-hour P-CPI group training session. This parent-based training in CPI's Nonviolent Crisis Intervention® will include nonverbal, paraverbal, verbal, and physical intervention techniques. Participants assigned to the waitlist group will be encouraged to continue their existing medical support, or services, as they typically would. The waitlist group will be invited to participate in the P-CPI training at the conclusion of the post-assessment period.

Baseline measures will be on the day of training for the treatment group and within five days of the P-CPI training for the waitlist group. Follow-up measures will be at 2-week, and 1, 2, and 3- month post-baseline. The treatment group will also participate in a follow-up group interview.

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
None

入排标准

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

入选标准

  • Each subject must be an adult caregiver/parent of a Lurie Center for Autism patient with 'patient' defined as having at minimum one visit/contact per year with any Lurie Center for Autism clinician. The patient (child):
  • May be male or female.
  • Must be from 5-12 years of age (inclusive).
  • Must live at home.
  • May have any IQ.
  • Must have an ASD diagnosis per the DSM-5 checklist confirmed by expert clinician at enrollment.
  • Must have a symptom severity score of 18 or greater on the ABC Irritability subscale confirmed by expert clinician at enrollment.
  • The subject may have any primary language but must be comfortable speaking and reading English without translation.
  • The subject must be the self-identified primary caregiver of the Lurie Center for Autism patient.
  • The subject must be recommended by a Lurie Center for Autism clinician.
  • The subject must be able to attend in person the maximum the training session on the specified date/time/location.
  • The subject must be willing to complete the assessment measures.
  • Only one subject per family may participate.

排除标准

  • The subject must not have any self-identified physical limitations or disabilities that prevent use of physical intervention techniques.
  • The patient (child) of the subject must not have any compromising neurological disorders (i.e., CP, active seizures).
  • The patient should not have the addition of non-drug treatment (including ABA and parent-training) for 4 weeks prior to intervention

结局指标

主要结局

Change in the Child Adjustment and Parent Efficacy Scale-Developmental Disability Self-Efficacy Scale Total Score

时间窗: Baseline and 2-weeks

The CAPES-DD self-efficacy scale is a 16-item brief outcome measure in the evaluation of individual parenting interventions that measures parents' self-efficacy in managing specific child behavior problems. Instructions were modified to ask about the previous two weeks instead of the previous four weeks. The range of possible scores is 16-160, with higher scores corresponding to greater parental self-efficacy and a positive change indicating improvement from baseline. Mean changes were estimated using repeated measures linear regression controlling for score at screening visit.

次要结局

  • Change in the Parent Stress Index - Short Form Total Score(Baseline and 2-weeks)
  • Change in the Family Quality of Life Scale Total Score(Baseline and 2-weeks)

研究者

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

Lisa A. Nowinski, PhD

Director, Neuropsychology Training

Massachusetts General Hospital

研究点 (2)

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