跳至主要内容
临床试验/NCT00402857
NCT00402857已完成3 期

Advanced Parenting Education in Pediatrics: The APEP Project

Tufts Medical Center17 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
345
试验地点
17
主要终点
Parenting behavior

研究概览

简要总结

This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

详细描述

Attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) are common childhood behavior disorders. Children with ADHD experience hyperactivity, distractibility, poor concentration, and impulsivity. If left untreated, ADHD can continue into adulthood, and can cause problems in family, social, and work environments. Children with ODD exhibit an ongoing pattern of uncooperative, defiant, and hostile behavior toward authority figures. Symptoms of ODD, including frequent temper tantrums, anger, resentment, and vindictiveness, may interfere with a child's everyday functioning. The Incredible Years parent training program has been shown to be effective in multiple settings at training parents to manage their child's behavior. This study will evaluate the effectiveness of the Incredible Years training program within a pediatric office setting at improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.

Participants in this open-label study will be randomly assigned to the Incredible Years training program or a waitlist condition, in which they will begin the program after a 1-year waiting period. Parent training sessions will take place once per week for 10 weeks, and will last approximately 2 hours each. Sessions will focus on teaching positive parenting skills, such as appropriate play and use of praise and rewards, as well as limit-setting techniques, such as ignoring, allowing children to experience the natural consequences of their actions, and assigning time-outs. Self-report assessments and phone interviews will be used to assess outcomes. Additionally, follow-up visits will occur immediately post-intervention and 6 and 12 months post-intervention. Children will attend one visit before the program begins, as well as the follow-ups held immediately post-intervention and 12 months post-intervention. These visits will include videotaped observations of children and their primary caregivers.

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
22 Months 至 38 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Parent or primary caregiver of a child who fits the following criteria:
  • Receives a positive result on behavioral screening

排除标准

  • Parent or primary caregiver of a child who fits the following criteria:
  • Diagnosis of pervasive developmental disorder or global developmental delay

结局指标

主要结局

Parenting behavior

时间窗: Measured post-intervention and at 6- and 12-month follow-ups

Child disruptive behaviors

时间窗: Measured post-intervention and at 6- and 12-month follow-ups

次要结局

  • Child and parent functional status/impairment(Measured post-intervention and at 6- and 12-month follow-ups)
  • Parenting stress(Measured post-intervention and at 6- and 12-month follow-ups)
  • Family functioning(Measured post-intervention and at 6- and 12-month follow-ups)
  • Consumer perspectives(Measured post-intervention and at 6- and 12-month follow-ups)
  • Cost of services(Measured post-intervention and at 6- and 12-month follow-ups)
  • Barriers to treatment(Measured post-intervention and at 6- and 12-month follow-ups)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

Loading locations...

相似试验