Trial Outcomes & Findings for Internet Based Cognitive Behavioral Therapy in Pediatric Chronic Pancreatitis (NCT NCT03707431)

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.

One participant preferred not to respond

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.

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.

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.

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.

Over the counter and prescription (opioid and non-opioid) medication use in the preceding 7 days.

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.

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.

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.

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.