Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children
REACH
Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
1 other identifier
interventional
460
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
February 17, 2026
February 1, 2026
3.5 years
February 6, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in parental encouragement of child illness behavior
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.
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Secondary Outcomes (13)
Change in anxiety
Baseline, 4-6 weeks, 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 perceived social support
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in health-related quality of life
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
- +8 more secondary outcomes
Study Arms (2)
Social Learning and Cognitive Behavioral Therapy (SLCBT)
EXPERIMENTALAttention Education Control
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- University of Washingtoncollaborator
Study Sites (1)
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
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.
PMID: 39160566DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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).
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Anesthesiology and Pain Medicine
Study Record Dates
First Submitted
February 6, 2023
First Posted
February 15, 2023
Study Start
October 16, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share