Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Change in parental encouragement of child illness behavior
研究概览
简要总结
The goal of this clinical trial is to test efficacy of the REACH program in parents with irritable bowel syndrome (IBS) and their young children. The main question it aims to answer is:
-How can parents with IBS help their young kids develop healthy habits?
Participants will be asked to complete online surveys and to use a website. Researchers will compare results from parents who use one of two websites chosen by chance, like flipping a coin. One website focuses on child health and safety behaviors. The other website focuses on strategies to promote child wellness behaviors.
详细描述
To date, preventive interventions have not been applied to reduce intergenerational transmission of pain conditions. There are several reasons that abdominal pain presents an ideal model for this important work. Abdominal pain is the second most common recurrent pain complaint of childhood. It is associated with disruption of normal activity, including school attendance and poor quality of life, and is emotionally distressing for both children and parents. Research demonstrates that illness behaviors are linked to development of abdominal pain disorders in children.
The investigators hypothesize that a social learning intervention modified toward a preventive focus for parents with IBS who have young children, ages 4-7 years, will reduce risk factors (anxiety, catastrophizing, parenting stress) and increase protective factors (positive affect, social support), resulting in lower parental solicitous behaviors, fewer child abdominal pain symptoms, reduced child health care utilization, and better child physical, psychological, social, and school functioning. The objective of the current application is to test the efficacy of an early preventive intervention targeting parents with IBS whose young children are thus at higher risk for developing abdominal pain. To enhance potential for scalability and dissemination, and meet parental preferences, the intervention is delivered via the internet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are not informed of their condition assignment and both receive online programs focused on healthy child behaviors. Investigators are blinded & masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for parents and their children (including biological/step-parents or legal guardians):
- •Parent/caregiver at least 18 years old
- •Parent diagnosed with IBS or idiopathic abdominal pain in the last five years OR
- •Parent meets ROME criteria for IBS (abdominal pain at least weekly; pain related to defecation, change in stool frequency, and change in stool form at least 30% of the time)
- •Is the parent primarily responsible for caring for the child on a day-to-day basis
- •Child is 4 to 7 years old at the time of screening. If multiple children are present in the family, the parent will be asked to select one child for study participation.
- •Child must currently live at least half of the time with the parent involved in intervention.
- •Parent and child must reside in the U.S.
排除标准
- •for parents and their children:
- •Not able to read/speak/understand English.
- •Child has a developmental disability that requires full-time special education
- •Child has chronic abdominal pain (pain most/every day for more than 3 months)
- •Child has a current doctor's diagnosis of a painful* gastrointestinal disorder like functional constipation, lactose/fructose/gluten intolerance, celiac disease, Inflammatory Bowel Disorder, etc. (*does not include nonpainful disorders like GERD)
- •Child has another severe chronic disease such as juvenile arthritis, cancer, or other severe condition(s) requiring chronic medical treatment.
- •Does not have regular access to the Internet on a desktop, tablet, phone, or laptop computer
研究组 & 干预措施
Social Learning and Cognitive Behavioral Therapy (SLCBT)
干预措施: Social Learning and Cognitive Behavioral Therapy (SLCBT) (Behavioral)
Attention Education Control
干预措施: Attention Education Control (Behavioral)
结局指标
主要结局
Change in parental encouragement of child illness behavior
时间窗: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Assesses self-reported parental encouragement of child illness behavior. The Adult Responses to Child Symptoms (ARCS) has 29-items that load onto 3 subscales (Protectiveness, Monitoring/Encouragement, Minimization). Responses are rated on a 5-point scale ranging from "never" to "always." . Higher average scores indicate that the responses are more frequently used, and thus higher scores are less adaptive ways of responding.
次要结局
- Change in health-related quality of life(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in health care costs(Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in pain catastrophizing(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in positive and negative affect(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in depressive symptoms(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in parenting stress(Baseline)
- Change in anxiety(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in perceived social support(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in pain intensity(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in somatic symptoms(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Change in abdominal pain symptoms(Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention)
- Treatment acceptability(4-6 weeks)
- Number of treatment contacts(0-6 weeks)
研究者
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital