Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children

Official title

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

Overview

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.

Detailed description

To date, preventive interventions have not been applied to reduce intergenerational transmission of pain conditions. There are several reasons that abdominal pain presents an ideal model for this important work. Abdominal pain is the second most common recurrent pain complaint of childhood. It is associated with disruption of normal activity, including school attendance and poor quality of life, and is emotionally distressing for both children and parents. Research demonstrates that illness behaviors are linked to development of abdominal pain disorders in children.

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.

Interventions

• Behavioral 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 pra
• Behavioral 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 measures

• 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]

Secondary outcome measures (12)

• Change in anxiety [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in pain catastrophizing [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in positive and negative affect [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in perceived social support [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in health-related quality of life [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in health care costs [Time frame: Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in pain intensity [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in somatic symptoms [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in abdominal pain symptoms [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in depressive symptoms [Time frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention]
• Change in parenting stress [Time frame: Baseline]
• Number of treatment contacts [Time frame: 0-6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Seattle Children's Hospital — Seattle

Publications

• 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 39160566

Identifiers

NCT: NCT05730491 · 1R01HD107794-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗