Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children
NCT ID: NCT05730491
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
460 participants
INTERVENTIONAL
2023-10-16
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
-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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Internet-delivered Exposure-based Cognitive Behavior Therapy for Irritable Bowel Syndrome - a Cohort Effectiveness Study
NCT05328245
Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)
NCT00844961
Diet and Motility in IBS
NCT07283341
Internet-delivered CBT for Irritable Bowel Syndrome in Adolescents
NCT02306369
Self Administered Cognitive Behavior Therapy for Irritable Bowel Syndrome
NCT00738920
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Social Learning and Cognitive Behavioral Therapy (SLCBT)
Social Learning and Cognitive Behavioral Therapy (SLCBT)
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.
Attention Education Control
Attention Education Control
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Social Learning and Cognitive Behavioral Therapy (SLCBT)
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.
Attention Education Control
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Washington
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tonya Palermo
Professor, Anesthesiology and Pain Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seattle Children's Hospital
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Levy RL, Murphy TB, van Tilburg MAL, Kuklinski MR, Bailey JA, Aalfs H, Badillo I, Diakhate H, Palermo TM. Protocol for a randomized controlled trial of an internet-based prevention intervention for young children at-risk for functional abdominal pain. Trials. 2024 Aug 19;25(1):549. doi: 10.1186/s13063-024-08371-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.