| Outcomes |
Primary outcome measures:
IMPACT‐III [ Time Frame: Change from baseline to 8 weeks. ] Pediatric inflammatory bowel disease‐specific health‐related quality of life measure. 'IMPACT' is not an abbreviation but rather the name of the scale. Minimum score 0 to maximum score 100, with higher score signifying better quality of life. Participants get a total score (0 to 100) and a score for each of 6 subscales (0 to 100): Bowel Symptoms (7 items), Treatment/Interventions (3 items), Social Functioning (12 items), Emotional Functioning (7 items), Body Image (3 items), Systemic Symptoms (3 items). Each of the 35 total items has 5 multiple choice options and is given a score of 0, 25, 50, 75, or 100 points. The subscale scores are an average of the scores for each item that corresponds to that subscale. The total score is an average of all item scores. Modified Cantril Ladder [ Time Frame: Change from baseline to 8 weeks. ] Single‐item quality of life measure. From 0 to 10, with 10 representing the best quality of life PedsQL 4.0 Generic Core Scale, Parent Proxy [ Time Frame: Change from baseline to 8 weeks. ] 'PedsQL' refers to Pediatric Quality of Life. This is a paediatric 23‐item measure of health‐related quality of life. Questions fall under 1 of 5 domains: Physical Functioning (8 items), Emotional Functioning (5), Social Functioning (5 items), School Functioning (5 items). The measure yields a total score and 2 summary scores: Physical Health (comprised of physical functioning domain) and Psychosocial Health (comprised of each item in the 5‐item emotional, social, and school functioning domains). Each item is rated on a 5‐point Likert scale. Total score and the 2 summary scores are linearly transformed into a 0‐to‐100 point scale, with higher scores representing better quality of life.
Secondary outcome measures:
PROMIS Pediatric Anxiety, short form [ Time Frame: Change from baseline to 8 weeks. ] PROMIS stands for Patient‐Reported Outcomes Measurement Information System. It includes 8 items, each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety, i.e. worse. The raw score is translated into a T‐score. The T‐score rescales the raw score into a standardised T‐score with a mean of 50 and an SD of 10. A person with a T‐score of 40 is therefore 1 SD below the mean. PROMIS Pediatric Depressive Symptoms, short form [ Time Frame: Change from baseline to 8 weeks. ] PROMIS stands for Patient‐Reported Outcomes Measurement Information System. It includes 8 items, each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater depressive symptoms, i.e. worse. The raw score is translated into a T‐score. The T‐score rescales the raw score into a standardised T‐score with a mean of 50 and an SD of 10. A person with a T‐score of 40 is therefore 1 SD below the mean. PROMIS Pediatric Sleep Disturbance, short form [ Time Frame: Change from baseline to 8 weeks. ] PROMIS stands for Patient‐Reported Outcomes Measurement Information System. It includes 8 items, each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep. The raw score is translated into a T‐score. The T‐score rescales the raw score into a standardised T‐score with a mean of 50 and an SD of 10. A person with a T‐score of 40 is therefore 1 SD below the mean. Pain Beliefs Questionnaire, short form [ Time Frame: Change from baseline to 8 weeks. ] This is an 18‐item measure designed to assess youth's beliefs about their abdominal pain. It is comprised of 3 subscales, each with 6 items: Pain Threat, Problem‐Focused Coping Efficacy (PFCE), and Emotion‐Focused Coping Efficacy (EFCE). The respondent rates each item on how true the statement is for them on a 5‐point scale ranging from 0 ("not at all true") to 4 ("very true"). Subscale scores are computed by averaging the items pertaining to each subscale. For Pain Threat, a higher score indicates stronger beliefs that one's pain represents a personal threat. For the PFCE and EFCE subscales, higher scores indicate a stronger belief in one's ability to cope with pain. Abdominal Pain Intensity [ Time Frame: Change from baseline to 8 weeks. ] 2 items are combined for a total score ranging from 0 to 20, with higher scores representing greater pain intensity. Each item is rated on a scale from 0 (no pain) to 10 (most possible pain). The first item assesses the respondent's worst pain in the past week, the second item the usual intensity of the pain experienced during the past week. Adapted from the Abdominal Pain Index, with permission. Health care utilisation [ Time Frame: Change from baseline to 8 weeks. ] By parent report, total number of contacts with healthcare provider for their child in the past 8 weeks, other than previously scheduled check‐ups, including emergency department visits, urgent care visits, and phone calls or messages to the doctor's office School absences [ Time Frame: Change from baseline to 8 weeks. ] By parent report, number of days of school the child has missed in the past 8 weeks (choices: 0, 1 to 3, 4 to 6, 7 to 10, more than 10 days). If on school break, parent asked to estimate as if school was in session, e.g. how many days the child had to miss usual activities. Abdominal Pain Frequency [ Time Frame: Change from baseline to 8 weeks. ] How many days did the respondent experience pain in the past week, with options being never, 1 to 2 days, 3 to 4 days, 5 to 6 days, or daily, with greater frequency of pain being worse. Adapted from the Abdominal Pain Index, with permission.
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