Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children
Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
Seattle Children's Hospital
460 participants
Oct 16, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- 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
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Interventions
Participants assigned to this group will complete an online program with 3 core skills, which will include strategies to promote wellness behaviors, use adaptive cognitive coping strategies, model wellness behaviors for their children, and determine when it is appropriate to take further action re: potential illness in their child. The website is interactive and self-guided. All participants will have access to the same resources and content, although based on responses to quizzes and skills practice questions, the automated feedback may differ slightly. The website includes treatment modules that share content via text, images, videos and recordings, a skills library that includes audio recordings of relaxation exercises, infographics to support skills practice, and behavioral assignments to record skills practice and receive automated feedback. Participants will review their knowledge at the end of each treatment module with brief quizzes.
Participants assigned to the control group will receive access to a web program and complete 3 modules focused on child health and safety behaviors, such as sports and water safety. These participants will review written/visual content on the above topics, take quizzes to test knowledge gained, and will be provided with brief assignments to increase child safety behaviors. All participants assigned to the control group will have access to the same educational content.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05730491