Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT05730491

Conditions

Irritable Bowel Syndrome

Abdominal Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Social Learning and Cognitive Behavioral Therapy (SLCBT)

Attention Education Control

Study Details

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.

Conditions

Irritable Bowel Syndrome

Abdominal Pain

Study ID

NCT05730491

Start date

Oct 16, 2023

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Social Learning and Cognitive Behavioral Therapy (SLCBT)

placebo comparator: Attention Education Control

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Tonya M Palermo, PhD

206-884-4208tonya.palermo@seattlechildrens.org

Rona L Levy, PhD, MPH

rlevy@uw.edu

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Tonya M Palermo, PhD

206-884-4208tonya.palermo@seattlechildrens.org

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • social learning
  • cognitive behavioral therapy
  • prevention intervention
  • irritable bowel syndrome
  • solicitous behavior
  • protective factors
  • psychosocial intervention
  • abdominal pain
  • risk factors
  • illness behavior

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-02-17.