Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeattle Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Social Learning and Cognitive Behavioral Therapy (SLCBT)
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: Social Learning and Cognitive Behavioral Therapy (SLCBT)Experimental treatment 1 intervention
Group B: Attention Education ControlPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-interventionSecondary outcomes
1
Change in anxiety
Parent self-report. The Generalized Anxiety Disorder (GAD2) is one of the most frequently used diagnostic self-report scales for screening, diagnosis and severity assessment of anxiety disorders in adults. The scale is based on two items which are scored from 0 to 3, with higher scores indicating greater anxiety symptoms.
Time frame
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention2
Change in pain catastrophizing
Parent self-report. Pain Catastrophizing Scale, is a 13-item measure that assesses catastrophizing thoughts or feelings accompanying the experience of pain. Respondents are asked to reflect on past painful experiences and to indicate the degree to which each of the 13 thoughts or feelings were experienced when in pain. Responses are from 0 (not at all) to 4 (all the time) with higher scores indicating higher levels of catastrophizing.
Time frame
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention3
Change in positive and negative affect
Parent self-report. Positive and Negative Affect Schedule (PANAS) is a widely used self-report measure that is made up of two mood scales. One 10-item scale measures positive affect and the other 10-item scale measures negative affect on a 5-point Likert scale. Scores range from 10-50 for each scale with higher scores indicating high levels of positive or negative affect.
Time frame
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention4
Change in perceived social support
Parent self-report. Perceived Social Support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). This scale consists of 12 items that measure the extent of social support received from 3 sources: friends, family, and significant others. Types of social support assessed by the MSPSS include emotional, tangible, informational, social network support, and esteem. Scores range from 12 to 84 with higher scores indicating greater social support.
Time frame
Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
University of Washington
Collaborator
Source ClinicalTrials.gov