Clinical trial NCT05730491: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Abdominal Pain
Keywords: social learning
cognitive behavioral therapy
prevention intervention
irritable bowel syndrome
solicitous behavior
protective factors
psychosocial intervention
abdominal pain
risk factors
illness behavior
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2023-02-15
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either an attention educational control website or social learning cognitive behavioral therapy (SLCBT) prevention intervention. A control arm is necessary in order to evaluate the efficacy of the SLCBT intervention.
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Change in parental encouragement of child illness behavior
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Secondary outcomes:
measure: Change in anxiety
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in pain catastrophizing
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in positive and negative affect
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in perceived social support
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in health-related quality of life
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in health care costs
timeFrame: Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in pain intensity
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in somatic symptoms
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in abdominal pain symptoms
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in depressive symptoms
timeFrame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in parenting stress
timeFrame: Baseline
measure: Number of treatment contacts
timeFrame: 0-6 weeks
measure: Treatment acceptability
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References: