Intergenerational Transmission of Illness Behavior
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
- 否
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)
