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临床试验/NCT03599648
NCT03599648已完成不适用

Testing the Efficacy of Mindfulness-Based Stress Reduction Combined With Behavioral Parent Training in Families With Preschoolers With Developmental Delay

University of Oregon4 个研究点 分布在 1 个国家目标入组 959 人开始时间: 2018年9月14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
959
试验地点
4
主要终点
Change From Baseline in Child Behavior Problems (Parent Report)

研究概览

简要总结

The Pro-Parenting Study seeks to determine the added benefit of targeting both parenting stress and parent management strategies to more effectively reduce behavior problems among children with developmental delay (DD). Findings from this study will improve the scientific understanding of evidence-based interventions for behavior problems among children with DD and the mechanisms underlying therapeutic change.

详细描述

Behavior problems are a common and concerning challenge among children with developmental delay (DD). Approximately 50% of children with DD have a comorbid mental disorder or serious behavior problems- a prevalence three times as high as that found in typically developing youths. Behavioral parent training (BPT) is the gold-standard intervention for treating child behavior problems in typically developing children and in children with DD. However, high levels of parental stress are associated with reduced or no response to BPT for children with DD. Consequently, parental stress may attenuate the efficacy of the gold-standard, empirically supported treatment for behavior problems among children with DD. As such, parental stress is a critical point of intervention for improving both parent and child outcomes in families of children with DD. The purpose of this study is to quantify the therapeutic benefit of adding a parent stress-reduction intervention prior to delivering BPT in order to more effectively reduce child behavior problems, and to investigate the mechanisms through which intervention outcomes occur.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent has a child ages 3 to 5 years with an agency-identified DD in one or more functional areas who is receiving early intervention or early childhood/ preschool special education through an individualized family service plan (IFSP) or individualized education plan (IEP);
  • Parent reports elevated child behavior problems, as indicated by a T-score of 60 or above on the Total Problems scale of the Child Behavior Checklist;
  • Parent reports elevated parenting stress, as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4.

排除标准

  • Parent screens positive for active psychosis, substance abuse, or suicidality;
  • Parent is currently receiving any form of psychological or behavioral treatment at the time of referral; or
  • The child has sensory impairments or nonambulatory conditions that would necessitate the need for significant modifications to the lab and home visit protocols.

结局指标

主要结局

Change From Baseline in Child Behavior Problems (Parent Report)

时间窗: baseline, immediately after 16-week intervention, 6 months, 12 months

Parents report on child behavior using the Child Behavior Checklist-Ages 1.5-5 years (Achenbach, 2000), a 99-item questionnaire that assesses behavioral problems in young children. Parents were asked to rate how accurately each item described their child's behavior over the past 2 months using a 3-pt scale (0=not true/ 1= somewhat or sometimes true/ 2= very true or often true). A Total Behavior Problems score was derived by taking the sum of all 99 items, with a possible range of 0-198. A high score indicates greater problem behavior.

次要结局

  • Change From Baseline in Parenting Behavior (Parent Report)(baseline, immediately after 16-week intervention, 6 months, 12 months)
  • Change From Baseline in Parenting Stress (Parent Self-Report)(baseline, immediately after 16-week intervention, 6 months, 12 months)

研究者

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

Laura Lee McIntyre

Professor & Dean, College of Education

University of Oregon

研究点 (4)

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