Irritable Bowel SyndromeREACHNCT05730491
Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children
A study testing Social Learning and Cognitive Behavioral Therapy (SLCBT) in people with Irritable Bowel Syndrome and Abdominal Pain, run by Seattle Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Abdominal Pain
- What is being tested?
- Social Learning and Cognitive Behavioral Therapy (SLCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rona L Levy, PhD, MPH contact
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Tonya M Palermo, PhD, 206-884-4208, tonya.palermo@seattlechildrens.org
About this study
Official title: Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain
- Being tested
- Social Learning and Cognitive Behavioral Therapy (SLCBT), Attention Education Control
- Keywords
- social learning, cognitive behavioral therapy, prevention intervention, irritable bowel syndrome, solicitous behavior, protective factors, psychosocial intervention, abdominal pain, risk factors, illness behavior
- Medical subject headings
- Irritable Bowel Syndrome, Abdominal Pain, Illness Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Learning and Cognitive Behavioral Therapy (SLCBT)Behavioural
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 ControlBehavioural
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 group | Role | What they receive |
|---|---|---|
| Social Learning and Cognitive Behavioral Therapy (SLCBT) | Experimental | Not described Receives: Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT) |
| Attention Education Control | Placebo comparator | Not described Receives: Behavioral: Attention Education Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Secondary outcomes (13)
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in health-related quality of life
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in health care costs
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.
Measured: Baseline, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in pain intensity
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in somatic symptoms
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in abdominal pain symptoms
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).
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in depressive symptoms
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.
Measured: Baseline, 4-6 weeks, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in parenting stress
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.
Measured: Baseline
Number of treatment contacts
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.
Measured: 0-6 weeks
Treatment acceptability
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.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start16 Oct 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730491
- Sponsor's protocol ID
- 1R01HD107794-01
- Acronym
- REACH
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39160566
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Internet-based Prevention Intervention for Parents With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05730491
- Acronym / sponsor ID
- REACH / 1R01HD107794-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Social Learning and Cognitive Behavioral Therapy (SLCBT) | Experimental | Behavioral: Social Learning and Cognitive Behavioral Therapy (SLCBT) |
| Attention Education Control | Placebo comparator | Behavioral: Attention Education Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Social Learning and Cognitive Behavioral Therapy (SLCBT) |
| Attention Education ControlParticipants 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. | Behavioural | Attention Education Control |
Primary outcome
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.
13 secondary outcomes
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
Treatment acceptability
Time frame: 4-6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 39160566Levy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rona L Levy, PhD, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Learning and Cognitive Behavioral Therapy (SLCBT) in people with Irritable Bowel Syndrome and Abdominal Pain, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tonya M Palermo, PhD (206-884-4208, tonya.palermo@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.