跳至主要内容
临床试验/NCT00494260
NCT00494260已完成2 期

Intergenerational Transmission of Illness Behavior

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
200
试验地点
4
主要终点
symptoms of recurrent abdominal pain

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with Recurrent Abdominal Pain (RAP).

详细描述

Recurrent Abdominal Pain (RAP) is one of many disorders in adults and children for which there is no identifiable organic or physiological cause, yet which is associated with illness behavior that has significant societal and personal costs. Although 10-15% of children have RAP, there is at present no accepted medical or behavioral treatment for it. We have conducted a series of studies that suggests that illness behavior is, at least in part, learned during childhood when parents model sick role behavior or respond to their children's somatic complaints in a way that encourages or reinforces sick role behavior. The goal of this project is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with RAP.

The study is a randomized clinical trial. Children with RAP are assigned to one of two treatment conditions: 1) a social learning and cognitive behavior therapy condition (SLCBT) or 2) an education and support condition (ES). The SLCBT protocol teaches parents and children cognitive-behavioral methods such as relaxation and coping for managing RAP pain and stress. Patients and parents in the ES condition receive educational information regarding nutrition and the gastrointestinal system. Both treatment arms consist of three sessions with a mental health professional, each one week apart.

Study families are recruited from physicians in the community and through community flyers and newsletters. Outcome measures are collected at baseline, end of treatment, and at follow-up evaluations conducted three, six and 12 months later. Measures are designed to assess: RAP symptoms, health care utilization, psychological symptoms, school absences, functional disabilities, and family stress).

Primary Hypothesis: Children in the SLCBT condition will exhibit a greater decrease in symptoms of RAP and related maladaptive behaviors and cognitions than children in a comparison condition.

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
Single (Participant)

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • child experienced at least 3 episodes of abdominal pain over a 3-month period which affected his/her activities
  • primary caregiver willing and able to complete questionnaires
  • child aged 7-17
  • child has lived with the primary caregiver full-time for at least the past 5 years and for at least half of his/her lifetime

排除标准

  • positive physical or laboratory findings which would explain the child's abdominal pain
  • chronic disease
  • major surgery in past year
  • developmental disabilities that require full-time special education or impair ability to respond
  • inability to comprehend English

结局指标

主要结局

symptoms of recurrent abdominal pain

时间窗: measured one week following treatment and again in 3, 6 and 12 months

disability

时间窗: measured one week following treatment and again in 3, 6 and 12 months

次要结局

  • parent behaviors(measured one week following treatment and again in 3, 6 and 12 months)
  • child coping behaviors(measured one week following treatment and again in 3, 6 and 12 months)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Sponsor

研究点 (4)

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