Online program to help parents with IBS support their children

Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome

This study is testing an online program to see if it can help parents with IBS support their young children and reduce their tummy pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Seattle Children's Hospital (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT05730491 on ClinicalTrials.gov

What this trial studies

This clinical trial tests the efficacy of the REACH program, an online social learning intervention designed for parents with irritable bowel syndrome (IBS) and their young children aged 4-7. Participants will complete online surveys and use one of two randomly assigned websites focused on either child health and safety behaviors or strategies to promote child wellness. The study aims to reduce risk factors such as anxiety and parenting stress while enhancing protective factors like social support, ultimately aiming to lower abdominal pain symptoms in children. The intervention is delivered via the internet to enhance scalability and accessibility.

Who should consider this trial

Good fit: Ideal candidates include parents or legal guardians aged 18 and older who have been diagnosed with IBS and have children aged 4 to 7 living with them.

Not a fit: Patients who do not speak English or have children with developmental disabilities requiring full-time special education may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could help parents with IBS foster healthier habits in their children, potentially reducing the risk of abdominal pain disorders.

How similar studies have performed: While preventive interventions for abdominal pain in children are relatively novel, similar approaches in social learning and cognitive behavioral therapy have shown promise in other contexts.

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

Where this trial is running

Seattle, Washington

• Seattle Children's Hospital — Seattle, Washington, United States (RECRUITING)

Study contacts

• Study coordinator: Tonya M Palermo, PhD

Conditions: Irritable Bowel Syndrome, Abdominal Pain, social learning, cognitive behavioral therapy, prevention intervention, irritable bowel syndrome, solicitous behavior, protective factors