Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Iowa | OTHER |
| University of Virginia | OTHER |
| Washington University School of Medicine | OTHER |
| M.D. Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Abdominal pain is common in children with chronic and acute recurring pancreatitis (CP, ARP), and as they continue into adulthood, the disease progresses with increased pain and greater exposure to opioids. Despite the relevancy of early pain self-management for childhood pancreatitis, there have been no studies of non-pharmacological pain intervention in this population. The proposed project will evaluate a web-based cognitive behavioral pain management program delivered to a cohort of well-phenotyped children with CP/ARP and some community participants to reduce pain, pain-related disability and enhance HRQOL; it will also identify genetic risk factors and clinical and behavioral phenotypic factors associated with treatment response to enable precision medicine approaches.
Abdominal pain is present in 81% of children and adolescents with CP and ARP. Effective treatments that target pain in these children will lessen the risk of opioid exposure and continued pain and disability into adulthood. We plan to recruit a large multicenter sample of 260 children and adolescents (ages 10-19 years) with CP/ARP and their parents from INSPPIRE 2 (INSPPIRE:INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers and pancreatitis community groups (e.g. NPF) to evaluate the efficacy of WebMAP, a web-based cognitive behavioral pain management program (CBT). The study design is a two (group) x three (time point) randomized, controlled, double-blinded trial. Participants will be randomly assigned to receive online access to either pain education (WebED) or CBT (WebMAP) over an 8-10 week treatment period. The primary study outcome is abdominal pain symptoms measured at pre-treatment, immediately post-treatment, and at 6-month follow-up. Secondary outcomes include pain-related disability, health-related quality of life, depression and anxiety symptoms, and medication use. This project represents a significant advance in pain management for children with CP/ARP by evaluating the first ever nonpharmacologic pain intervention in these patients, which may guide future developments in the management of chronic pain associated with CP/ARP.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based CBT (WebMAP) | Experimental | Receives access to WebMAP |
|
| Pain Education (WebED) | Active Comparator | Receives access to WebED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based CBT | Behavioral | The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adolescent Abdominal Pain Severity | The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity. | Baseline, 12 weeks, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain-related Disability | The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability. The maximum possible total score is 36. |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tonya Palermo, PhD | Seattle Children's Hospital | Principal Investigator |
| Aliye Uc, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31756383 | Background | Palermo TM, Murray C, Aalfs H, Abu-El-Haija M, Barth B, Bellin MD, Ellery K, Fishman DS, Gariepy CE, Giefer MJ, Goday P, Gonska T, Heyman MB, Husain SZ, Lin TK, Liu QY, Mascarenhas MR, Maqbool A, McFerron B, Morinville VD, Nathan JD, Ooi CY, Perito ER, Pohl JF, Schwarzenberg SJ, Sellers ZM, Serrano J, Shah U, Troendle D, Zheng Y, Yuan Y, Lowe M, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer. Web-based cognitive-behavioral intervention for pain in pediatric acute recurrent and chronic pancreatitis: Protocol of a multicenter randomized controlled trial from the study of chronic pancreatitis, diabetes and pancreatic cancer (CPDPC). Contemp Clin Trials. 2020 Jan;88:105898. doi: 10.1016/j.cct.2019.105898. Epub 2019 Nov 19. | |
| 41385443 |
Not provided
Not provided
Not provided
We enrolled 90 adolescents (ages 10-19, 63% female) with ARP or CP and their parents or caregivers into this randomized placebo-controlled multicenter trial from 15 INSPPIRE (INternational Study Group of Pediatric Pancreatitis: In search for a cuRE) centers or from the community. The number of participants refers to dyads (parents and adolescents). Enrollment, randomization and progression through the study was by dyad.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pain Education (WebED) | Receives access to WebED. The education condition serves as an attention control condition to equalize time, attention, and computer usage by providing relevant information about chronic pain and pancreatitis pain. The program contains 8 modules with information compiled from publicly available educational websites about chronic pain (e.g., WebMD, AboutKidsHealth, NPF). The control version does not include any instruction on the behavioral and cognitive skills taught within the WebMAP-CP program. Children and parents received the same instructions to log in and complete one education module per week. In our prior RCTs that have used a pain education control website, parents and children have shown a high level of engagement and high ratings of treatment credibility. |
| FG001 | Web-based CBT (WebMAP) | Receives access to WebMAP. The program design and treatment content of WebMAP follow cognitive-behavioral, social learning, and family systems' frameworks. This interactive, travel-themed program teaches relaxation skills, pain coping strategies, parent behavioral techniques, and parent communication methods. Because the original program was developed for children with a range of chronic pain conditions, we made several adaptations to tailor the program for pediatric ARP/CP (e.g., tailoring patient vignettes and videos, providing education on pain related to pancreatitis). The eight child intervention modules include: 1) education about pancreatitis related pain, 2) recognizing stress and negative emotions, 3) relaxation strategies (e.g., imagery, deep breathing, progressive muscle relaxation), 4) implementing coping skills at school, 5) cognitive skills (e.g., recognizing and reducing negative thoughts), 6) lifestyle interventions (e.g., sleep habits, diet), 7) staying active (e.g., activity pacing), and 8) relapse prevention. The eight parent intervention modules are: 1) education about pancreatitis related pain, 2) recognizing child stress and negative emotions, 3) behavioral strategies to increase their child's positive coping (e.g., use of attention and praise), 4) implementing strategies to support school goals, 5) modeling positive coping strategies, 6) implementing child sleep and lifestyle interventions, 7) family communication, and 8) relapse prevention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Intervention |
| |||||||||||||
| Post-Treatment (T2) |
| |||||||||||||
| 6-Month Follow-up (T3) |
|
Baseline data for analysis were derived from adolescent participants only, not parent participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pain Education (WebED) | Receives access to WebED. The education condition serves as an attention control condition to equalize time, attention, and computer usage by providing relevant information about chronic pain and pancreatitis pain. The program contains 8 modules with information compiled from publicly available educational websites about chronic pain (e.g., WebMD, AboutKidsHealth, NPF). The control version does not include any instruction on the behavioral and cognitive skills taught within the WebMAP-CP program. Children and parents received the same instructions to log in and complete one education module per week. In our prior RCTs that have used a pain education control website, parents and children have shown a high level of engagement and high ratings of treatment credibility. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Adolescent participant age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Adolescent Abdominal Pain Severity | The Abdominal Pain Index (API) assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. An index is computed with higher scores indicating greater abdominal pain severity. A mean score is reported on a scale of 0 to 4, where higher values indicate more severe (worse) abdominal pain severity. | Adolescent data only. 3 participants were missing API data at T2 in the WebMAP condition. 1 participant was missing API data at T3 in the WebED condition and 2 were missing API data at T3 in the WebMAP condition. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12 weeks, 6 months |
|
From enrollment until the end of follow-up (6 months post-treatment)
Given the minimal risk nature of the study and lack of EHR access, adverse events were not systematically collected or documented for adolescent or parent participants, and could only be received via voluntary participant self-report. Adverse event reporting was limited to unanticipated problems determined to be related to study participation, of which there were none.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pain Education (WebED): Adolescents | Receives access to WebED. The education condition serves as an attention control condition to equalize time, attention, and computer usage by providing relevant information about chronic pain and pancreatitis pain. The program contains 8 modules with information compiled from publicly available educational websites about chronic pain (e.g., WebMD, AboutKidsHealth, NPF). The control version does not include any instruction on the behavioral and cognitive skills taught within the WebMAP-CP program. Children and parents received the same instructions to log in and complete one education module per week. In our prior RCTs that have used a pain education control website, parents and children have shown a high level of engagement and high ratings of treatment credibility. |
Not provided
Not provided
We relied on a self-reported diagnosis of ARP or CP for adolescents from the community, which may be inaccurate, and could have impacted our ability to distinguish between diagnostic groups. In addition, we did not reach our enrollment goal due to the COVID-19 pandemic's impact on clinic visits and a lower frequency of pain complaints than anticipated, causing many participants to be ineligible. This made it less likely we would statistically detect a small or moderate effect ("underpowered").
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tonya Palermo | Seattle Children's Research Institute | 2068840000 | tonya.palermo@seattlechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2024 | Mar 16, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Community Cohort Consent Form | Jun 3, 2020 | Jan 27, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: INSPPIRE Cohort Consent Form | Jun 3, 2020 | Jan 27, 2026 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D010195 | Pancreatitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| University of Toronto | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
| Medical College of Wisconsin | OTHER |
| Massachusetts General Hospital | OTHER |
| University of Minnesota | OTHER |
| Ohio State University | OTHER |
| University of Pittsburgh | OTHER |
| University of California, San Francisco | OTHER |
| University of Utah | OTHER |
| Indiana University | OTHER |
| Sydney Children's Hospitals Network | OTHER |
| Cedars-Sinai Medical Center | OTHER |
| Stanford University | OTHER |
| Ariel Precision Medicine | INDUSTRY |
| University of Texas Southwestern Medical Center | OTHER |
Randomized and double-blinded controlled trial of web-based CBT (WebMAP) vs pain education (WebED).
Not provided
Not provided
Not provided
|
|
| Pain Education | Behavioral | The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program. |
|
|
| Baseline, 12 weeks, 6 months |
| Change in Health-related Quality of Life | The Pediatric Quality of Life Inventory (Peds-QL) assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used as it demonstrates good reliability for both the parent and child self-report measures. Higher scores indicate fewer difficulties (better) health-related quality of life. Sub scales of physical and psychosocial health will be used in analyses. All scales range from 0 to 100. | Baseline, 12 weeks, 6 months |
| Change in Emotional Distress | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety (Pediatric v2.0 SF8a Anxiety) that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms (Pediatric v2.0 SF8a Depressive Symptoms) that evaluates negative mood, view of self and social cognitions. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4. | Baseline, 12 weeks, 6 months |
| Change in Opioid Use | Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days. | Baseline, 6 months |
| Change in Pain Self-efficacy | The Pain Self-Efficacy Scale is a 7-item measure that assesses the child's beliefs in carrying out activities when in pain. The scale has demonstrated good internal consistency, cross-informant reliability with parent report, and strong construct validity. Higher scores (score range 7-35) indicate higher self-efficacy. | Baseline, 12 weeks, 6 months |
| Change in Parent Impact of Pain | Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact Questionnaire (BAPQ-PIQ), a measure of the impact of parenting an adolescent with chronic pain. The BAPQ-PIQ is a 62-item questionnaire with 8 scales including: depressive symptoms, anxiety, pain catastrophizing, self-blame, partner relationship, social (leisure) functioning, parental behavior, and parental role strain. Items are rated on a 5-point frequency response scale (0 = never, 4 = always) with higher scores indicating more impaired (worse) functioning for all subscales. The BAPQ-PIQ has demonstrated good reliability and validity among parents of youth with chronic pain. Sub scales will be analyzed separately. For brevity given the number of time points and subscales, the depression (range: 0-36) and anxiety (range: 0-24) subscales are reported here. | Baseline, 12 weeks, 6 months |
| Change in Pain Interference | The PROMIS Pain Interference - v2.0 Pediatric Short Form 8a includes 8 items to assess consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The scale has been validated in pediatric patients with chronic pain. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. T-scores range from 34-78. The general population mean T-score is 50, with a standard deviation of 10. | Baseline, 12 weeks, 6 months |
| Change in Health Service Utilization | Parents will complete the Client Service Receipt Inventory-Pain version, a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used by category, number of lost parental work days, and number of out-of-pocket expenses; visits, medications, other treatments, and indirect costs as reported by the parent. For brevity, we will report the 2 primary variables used in analysis found to be related to child pain: the number of doctor outpatient service visits and number of emergency dept visits. | Baseline, 6 months |
| Derived |
| Palermo TM, Li R, Zhou C, Aalfs H, Cress G, Lowe M, Abu-El-Haija M, Chugh A, Downs EM, Fishman DS, Freeman AJ, Giefer MJ, Gonska TY, Husain SZ, Lindblad D, Liu QY, Maqbool A, Mark JA, McFerron BA, Mehta MS, Noel RA, Perito ER, Wang F, Yuan Y, Zheng Y, Uc A; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Internet-delivered Cognitive-Behavioral Intervention for Pain in Pediatric Acute Recurrent and Chronic Pancreatitis: A Multicenter Randomized Controlled Trial. Pancreas. 2026 Feb 1;55(2):e137-e146. doi: 10.1097/MPA.0000000000002558. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | Web-based CBT (WebMAP) | Receives access to WebMAP. The program design and treatment content of WebMAP follow cognitive-behavioral, social learning, and family systems' frameworks. This interactive, travel-themed program teaches relaxation skills, pain coping strategies, parent behavioral techniques, and parent communication methods. Because the original program was developed for children with a range of chronic pain conditions, we made several adaptations to tailor the program for pediatric ARP/CP (e.g., tailoring patient vignettes and videos, providing education on pain related to pancreatitis). The eight child intervention modules include: 1) education about pancreatitis related pain, 2) recognizing stress and negative emotions, 3) relaxation strategies (e.g., imagery, deep breathing, progressive muscle relaxation), 4) implementing coping skills at school, 5) cognitive skills (e.g., recognizing and reducing negative thoughts), 6) lifestyle interventions (e.g., sleep habits, diet), 7) staying active (e.g., activity pacing), and 8) relapse prevention. The eight parent intervention modules are: 1) education about pancreatitis related pain, 2) recognizing child stress and negative emotions, 3) behavioral strategies to increase their child's positive coping (e.g., use of attention and praise), 4) implementing strategies to support school goals, 5) modeling positive coping strategies, 6) implementing child sleep and lifestyle interventions, 7) family communication, and 8) relapse prevention. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| age (years) |
|
| Sex: Female, Male | Adolescent birth sex | One participant preferred not to respond | Count of Participants | Participants |
|
| Race (NIH/OMB) | Adolescent race | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Adolescent ethnicity | Count of Participants | Participants |
|
| Adolescent Pancreatitis Diagnosis Type | Diagnosis details could not be obtained for 3 community participants. | Count of Participants | Participants |
|
| Recruitment Source | Whether participants were referred from the INSPPIRE2 cohort study or the community | Count of Participants | Participants |
|
| OG001 | Web-based CBT (WebMAP) | Receives access to WebMAP. The program design and treatment content of WebMAP follow cognitive-behavioral, social learning, and family systems' frameworks. This interactive, travel-themed program teaches relaxation skills, pain coping strategies, parent behavioral techniques, and parent communication methods. Because the original program was developed for children with a range of chronic pain conditions, we made several adaptations to tailor the program for pediatric ARP/CP (e.g., tailoring patient vignettes and videos, providing education on pain related to pancreatitis). The eight child intervention modules include: 1) education about pancreatitis related pain, 2) recognizing stress and negative emotions, 3) relaxation strategies (e.g., imagery, deep breathing, progressive muscle relaxation), 4) implementing coping skills at school, 5) cognitive skills (e.g., recognizing and reducing negative thoughts), 6) lifestyle interventions (e.g., sleep habits, diet), 7) staying active (e.g., activity pacing), and 8) relapse prevention. The eight parent intervention modules are: 1) education about pancreatitis related pain, 2) recognizing child stress and negative emotions, 3) behavioral strategies to increase their child's positive coping (e.g., use of attention and praise), 4) implementing strategies to support school goals, 5) modeling positive coping strategies, 6) implementing child sleep and lifestyle interventions, 7) family communication, and 8) relapse prevention. |
|
|
| Secondary | Change in Pain-related Disability | The Child Activity Limitations Interview (CALI-9) is a daily diary validated to assess perceived difficulty in completing 9 daily activities as a measure of pain-related disability. Responses are rated on a 5-point scale (0-4) with higher scores indicating greater perceived difficulty with activities. Youth will provide ratings daily for 7 days on their online diaries at each assessment period. Mean total activity limitations across the reporting period is used in analyses, with higher scores indicating greater disability. The maximum possible total score is 36. | Adolescent data only. There is some missing or incomplete data at T2 and T3, due to withdrawn or lost-to-follow-up participants, or partial completion of measure. Note: there was increased partial completion and resulting missingness on the CALI because certain participants reported that they did not have a chance to participate in certain activities, thus, for those activities they could not report their pain-related disability levels. | Posted | Mean | Standard Deviation | CALI total score (7-day average) | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Health-related Quality of Life | The Pediatric Quality of Life Inventory (Peds-QL) assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used as it demonstrates good reliability for both the parent and child self-report measures. Higher scores indicate fewer difficulties (better) health-related quality of life. Sub scales of physical and psychosocial health will be used in analyses. All scales range from 0 to 100. | Adolescent data only. There is some missing or incomplete data at T2 and T3, due to withdrawn or lost-to-follow-up participants. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Emotional Distress | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety (Pediatric v2.0 SF8a Anxiety) that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms (Pediatric v2.0 SF8a Depressive Symptoms) that evaluates negative mood, view of self and social cognitions. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. The general population mean T-score is 50, with a standard deviation of 10. Anxiety T-scores range from 33.5-83.3, and depression T-scores range from 35.2-82.4. | Adolescent data only. There is some missing or incomplete data at T2 and T3, due to withdrawn or lost-to-follow-up participants. | Posted | Mean | Standard Deviation | T-score | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Opioid Use | Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days. | Adolescent opioid use data only. Some missing data at T3. | Posted | Count of Participants | Participants | Baseline, 6 months |
|
|
|
| Secondary | Change in Pain Self-efficacy | The Pain Self-Efficacy Scale is a 7-item measure that assesses the child's beliefs in carrying out activities when in pain. The scale has demonstrated good internal consistency, cross-informant reliability with parent report, and strong construct validity. Higher scores (score range 7-35) indicate higher self-efficacy. | Adolescent data only. Some missing data at T2 and T3 due to withdrawal or lost to follow-up. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Parent Impact of Pain | Parents will complete the Bath Adolescent Pain Questionnaire-Parent Impact Questionnaire (BAPQ-PIQ), a measure of the impact of parenting an adolescent with chronic pain. The BAPQ-PIQ is a 62-item questionnaire with 8 scales including: depressive symptoms, anxiety, pain catastrophizing, self-blame, partner relationship, social (leisure) functioning, parental behavior, and parental role strain. Items are rated on a 5-point frequency response scale (0 = never, 4 = always) with higher scores indicating more impaired (worse) functioning for all subscales. The BAPQ-PIQ has demonstrated good reliability and validity among parents of youth with chronic pain. Sub scales will be analyzed separately. For brevity given the number of time points and subscales, the depression (range: 0-36) and anxiety (range: 0-24) subscales are reported here. | Parent data only. There is some missing data on these subscales across all time points. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Pain Interference | The PROMIS Pain Interference - v2.0 Pediatric Short Form 8a includes 8 items to assess consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The scale has been validated in pediatric patients with chronic pain. Raw scores and T-scores are computed with T-scores above 60 indicating clinically elevated (worse) symptoms. T-scores range from 34-78. The general population mean T-score is 50, with a standard deviation of 10. | Adolescent data only. Some missing data at T2 and T3. | Posted | Mean | Standard Deviation | T Score | Baseline, 12 weeks, 6 months |
|
|
|
| Secondary | Change in Health Service Utilization | Parents will complete the Client Service Receipt Inventory-Pain version, a measure of service use, out-of-pocket expenses, and lost work time incurred by families for the evaluation or management of the child's chronic pain. Questions pertain to hospital admissions, outpatient services, community services (e.g., tutor, lawyer), medications, lost work time, paid help, and other costs. We will compute the following variables: total number of services used by category, number of lost parental work days, and number of out-of-pocket expenses; visits, medications, other treatments, and indirect costs as reported by the parent. For brevity, we will report the 2 primary variables used in analysis found to be related to child pain: the number of doctor outpatient service visits and number of emergency dept visits. | Parent data only. Some missing data at T1 and T3. | Posted | Mean | Standard Deviation | number of visits | Baseline, 6 months |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Web-based CBT (WebMAP): Adolescents | Receives access to WebMAP. The program design and treatment content of WebMAP follow cognitive-behavioral, social learning, and family systems' frameworks. This interactive, travel-themed program teaches relaxation skills, pain coping strategies, parent behavioral techniques, and parent communication methods. Because the original program was developed for children with a range of chronic pain conditions, we made several adaptations to tailor the program for pediatric ARP/CP (e.g., tailoring patient vignettes and videos, providing education on pain related to pancreatitis). The eight child intervention modules include: 1) education about pancreatitis related pain, 2) recognizing stress and negative emotions, 3) relaxation strategies (e.g., imagery, deep breathing, progressive muscle relaxation), 4) implementing coping skills at school, 5) cognitive skills (e.g., recognizing and reducing negative thoughts), 6) lifestyle interventions (e.g., sleep habits, diet), 7) staying active (e.g., activity pacing), and 8) relapse prevention. The eight parent intervention modules are: 1) education about pancreatitis related pain, 2) recognizing child stress and negative emotions, 3) behavioral strategies to increase their child's positive coping (e.g., use of attention and praise), 4) implementing strategies to support school goals, 5) modeling positive coping strategies, 6) implementing child sleep and lifestyle interventions, 7) family communication, and 8) relapse prevention. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG002 | Pain Education (WebED): Parents | Receives access to WebED. The education condition serves as an attention control condition to equalize time, attention, and computer usage by providing relevant information about chronic pain and pancreatitis pain. The program contains 8 modules with information compiled from publicly available educational websites about chronic pain (e.g., WebMD, AboutKidsHealth, NPF). The control version does not include any instruction on the behavioral and cognitive skills taught within the WebMAP-CP program. Children and parents received the same instructions to log in and complete one education module per week. In our prior RCTs that have used a pain education control website, parents and children have shown a high level of engagement and high ratings of treatment credibility. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG003 | Web-based CBT (WebMAP): Parents | Receives access to WebMAP. The program design and treatment content of WebMAP follow cognitive-behavioral, social learning, and family systems' frameworks. This interactive, travel-themed program teaches relaxation skills, pain coping strategies, parent behavioral techniques, and parent communication methods. Because the original program was developed for children with a range of chronic pain conditions, we made several adaptations to tailor the program for pediatric ARP/CP (e.g., tailoring patient vignettes and videos, providing education on pain related to pancreatitis). The eight child intervention modules include: 1) education about pancreatitis related pain, 2) recognizing stress and negative emotions, 3) relaxation strategies (e.g., imagery, deep breathing, progressive muscle relaxation), 4) implementing coping skills at school, 5) cognitive skills (e.g., recognizing and reducing negative thoughts), 6) lifestyle interventions (e.g., sleep habits, diet), 7) staying active (e.g., activity pacing), and 8) relapse prevention. The eight parent intervention modules are: 1) education about pancreatitis related pain, 2) recognizing child stress and negative emotions, 3) behavioral strategies to increase their child's positive coping (e.g., use of attention and praise), 4) implementing strategies to support school goals, 5) modeling positive coping strategies, 6) implementing child sleep and lifestyle interventions, 7) family communication, and 8) relapse prevention. | 0 | 46 | 0 | 46 | 0 | 46 |
Not provided
Not provided
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Unknown |
|
| T2 (Post-treatment, 12 weeks) |
|
|
| T3 (6-month Follow-up) |
|
|
| T2 Physical Health (Post-treatment, 12 weeks) |
|
|
| T3 Physical Health (6-month follow-up) |
|
|
| T1 Psychosocial Health (Baseline) |
|
|
| T2 Psychosocial Health (Post-treatment, 12 weeks) |
|
|
| T3 Psychosocial Health (6-month follow-up) |
|
|
| T2 Depression (Post-treatment, 12 weeks) |
|
|
| T3 Depression (6-month follow-up) |
|
|
| T1 Anxiety (Baseline) |
|
|
| T2 Anxiety (Post-treatment, 12 weeks) |
|
|
| T3 Anxiety (6-month follow-up) |
|
|
| Not using opioid medication |
|
| T3 (6-month follow-up) |
|
|
| T2 (Post-treatment, 12 weeks) |
|
|
| T3 (6-month follow-up) |
|
|
| T2 Depression (Post-treatment, 12 weeks) |
|
|
| T3 Depression (6-month follow-up) |
|
|
| T1 Anxiety (Baseline) |
|
|
| T2 Anxiety (Post-treatment, 12 weeks) |
|
|
| T3 Anxiety (6-month follow-up) |
|
|
| T2 (Post-treatment, 12 weeks) |
|
|
| T3 (6-month follow-up) |
|
|
| T3 Emergency Visits (6-month follow-up) |
|
|
| T1 Outpatient Dr Visits (Baseline) |
|
|
| T3 Outpatient Dr Visits (6-month follow-up) |
|
|