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

• ClinicalTrials.gov Identifier: NCT05730491
• Recruitment Status: Recruiting
• First Posted: February 15, 2023
• Last Update Posted: March 7, 2024
• Sponsor: Seattle Children's Hospital
• Collaborator: University of Washington
• Information provided by (Responsible Party): Tonya Palermo, Seattle Children's Hospital

Tracking Information

• First Submitted Date: February 6, 2023
• First Posted Date: February 15, 2023
• Last Update Posted Date: March 7, 2024
• Actual Study Start Date: October 16, 2023
• Estimated Primary Completion Date: October 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2023)

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 ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 8, 2024)

• Change in anxiety [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  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.
• Change in pain catastrophizing [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  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.
• 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 ]
  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.
• Change in perceived social support [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  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.
• 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 ]
  Parent proxy report and child self-report (ages 7+). The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children. The measure can be completed by parents (the Proxy Report) for children as young as age 2 years. The 23 items in the PedsQL comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Two Summary Scores can be computed (the Psychosocial Health Summary Score and the Physical Health Summary Score), as well as a Total Scale Score. Scores range from 0-100, with higher scores indicating better quality of life.
• Change in health care costs [ Time Frame: Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parents will complete the Client Service Receipt Inventory (CSRI), a validated comprehensive inventory of health care services incurred due to the child's symptoms that uses a standard response timeframe of the past 6 months. In the CSRI, parents report on three sources of health care costs: direct medical service use, direct non-medical costs, and indirect costs. In order to better estimate costs, monetary values will be assigned to health resources use and productivity time loss data captured in the CSRI. All expenditures will be converted to 2023 dollars using the medical care component of the Consumer Price Index available from the Bureau of Labor Statistics. Costs will be aggregated across the three sources to derive total costs for analyses.
• Change in pain intensity [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent proxy report and child self-report (ages 7+). The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity form includes three items assessing child's pain intensity in the past 7 days.
• Change in somatic symptoms [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent proxy report. The Children's Somatic Symptoms Inventory (CSSI-8) includes 8 items assessing the severity of a child's nonspecific somatic symptoms. The set of GI symptoms (pain, nausea, upset stomach) are used to measure GI symptom severity.
• Change in abdominal pain symptoms [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent proxy report. The ROME Functional Abdominal Pain questions include 5 items assessing ROME criteria for upper and lower functional abdominal pain - frequency, severity, location, and association with eating (lower only).
• Change in depressive symptoms [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent self-report. The Patient Health Questionnaire (PHQ2) includes 2 items inquiring about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks.
• Change in parenting stress [ Time Frame: Baseline ]
  Parent self-report. The Daily Parenting Hassles Scale is a 20-item scale that assesses parent burden in meeting the needs of their children and troublesome behavior of children. Subscales include challenging behavior and parenting tasks.
• Number of treatment contacts [ Time Frame: 0-6 weeks ]
  The administrative backend of the intervention programs has a tracking system for recording use of the program. Specifically, we will measure: 1) logins to the program, 2) completed treatment modules, and 3) completed assignments.
• Treatment acceptability [ Time Frame: 4-6 weeks ]
  The TEI-SF is a 9-item measure that assesses treatment acceptability and satisfaction. Select items were adapted to be specific to a parenting prevention program (e.g., "I find this intervention to be an acceptable way of dealing with young children's health"). Items are rated on a 5-point scale (1 = 'strongly disagree', 5 = 'strongly agree') and summed to create a total score, with higher scores indicating higher acceptability and satisfaction.

Original Secondary Outcome Measures (submitted: February 14, 2023)

• Change in anxiety [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent self-report. Generalized Anxiety Disorder scale (GAD-7), 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 seven items which are scored from 0 to 3, with higher scores indicating greater anxiety symptoms.
• Change in pain catastrophizing [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  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.
• 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 ]
  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.
• Change in perceived social support [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  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.
• Change in somatic symptoms [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  The Gastrointestinal symptom severity subscale of the Children's Somatization Inventory - Short Form (CSI-24) will be completed via parent proxy report. The CSI-24 assesses the severity of nonspecific somatic symptoms. Items are rated on a 0-4 scale (0 = not at all to 4 = a whole lot) and asks respondents to rate how much their child was bothered by specific symptoms in the previous 2 weeks. There are seven GI symptoms (nausea, pain, food making child sick, bloating, constipation, diarrhea, and vomiting) that measure GI symptom severity. Higher scores indicate greater somatic symptoms.
• Change in abdominal pain severity [ Time Frame: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parent proxy report: The Abdominal Pain Index (API) assesses characteristics of children's abdominal pain during the previous 2 weeks. The frequency of abdominal pain episodes during the previous 2 weeks is rated on a 6-point scale ranging from (0) not at all to (5) every day. The typical daily frequency of abdominal pain episodes is rated on a 6-point scale ranging from (0) none to (5) constant during the day. The typical duration of pain episodes is rated on a 9-point scale ranging from (0) none to (8) all day. The typical intensity of abdominal pain in the past two weeks is rated on an 11-point scale ranging from (0) no pain to (10) the most pain possible. To create a composite score for the API, use the following procedure: (1) items that are not already on a 6-point scale are converted to a scale ranging from 0 to 5, (2) the mean of all four items is taken to achieve a score ranging from 0 to 5, with higher scores indicating greater abdominal pain severity.
• 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 ]
  Parent proxy report and child self-report (ages 7+). The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children. The measure can be completed by parents (the Proxy Report) for children as young as age 2 years. The 23 items in the PedsQL comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Two Summary Scores can be computed (the Psychosocial Health Summary Score and the Physical Health Summary Score), as well as a Total Scale Score. Scores range from 0-100, with higher scores indicating better quality of life.
• Change in health care costs [ Time Frame: Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]
  Parents will complete the Client Service Receipt Inventory (CSRI), a validated comprehensive inventory of health care services incurred due to the child's symptoms that uses a standard response timeframe of the past 6 months. In the CSRI, parents report on three sources of health care costs: direct medical service use, direct non-medical costs, and indirect costs. In order to better estimate costs, monetary values will be assigned to health resources use and productivity time loss data captured in the CSRI. All expenditures will be converted to 2023 dollars using the medical care component of the Consumer Price Index available from the Bureau of Labor Statistics. Costs will be aggregated across the three sources to derive total costs for analyses.
• Number of treatment contacts [ Time Frame: 0-6 weeks ]
  The administrative backend of the intervention programs has a tracking system for recording use of the program. Specifically, we will measure: 1) logins to the program, 2) completed treatment modules, and 3) completed assignments.
• Treatment acceptability [ Time Frame: 4-6 weeks ]
  The TEI-SF is a 9-item measure that assesses treatment acceptability and satisfaction. Select items were adapted to be specific to a parenting prevention program (e.g., "I find this intervention to be an acceptable way of dealing with young children's health"). Items are rated on a 5-point scale (1 = 'strongly disagree', 5 = 'strongly agree') and summed to create a total score, with higher scores indicating higher acceptability and satisfaction.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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).

Primary Purpose: Prevention

Condition

• Irritable Bowel Syndrome
• Abdominal Pain

Intervention

• 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 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.
• 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.

Study Arms

• Experimental: Social Learning and Cognitive Behavioral Therapy (SLCBT)
  Intervention: Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT)
• Placebo Comparator: Attention Education Control
  Intervention: Behavioral: Attention Education Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 14, 2023): 460
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2027
• Estimated Primary Completion Date: October 31, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tonya M Palermo, PhD; 206-884-4208; tonya.palermo@seattlechildrens.org

Contact: Rona L Levy, PhD, MPH; rlevy@uw.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05730491
• Other Study ID Numbers: 1R01HD107794-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tonya Palermo, Seattle Children's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seattle Children's Hospital
• Original Study Sponsor: Same as current
• Collaborators: University of Washington
• Investigators: Not Provided
• PRS Account: Seattle Children's Hospital
• Verification Date: March 2024