Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
Overview
- Phase
- N/A
- Intervention
- Social Learning and Cognitive Behavioral Therapy (SLCBT)
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- Seattle Children's Hospital
- Enrollment
- 460
- Locations
- 1
- Primary Endpoint
- Change in parental encouragement of child illness behavior
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Seattle Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Social Learning and Cognitive Behavioral Therapy (SLCBT)
Intervention: Social Learning and Cognitive Behavioral Therapy (SLCBT)
Attention Education Control
Intervention: Attention Education Control
Outcomes
Primary Outcomes
Change in parental encouragement of child illness behavior
Time Frame: 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.
Secondary Outcomes
- 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)