181 Hydrocortisone as an intervention (RCT) 6 Primary outcome Neurobehavioral problems To answer our primary aim, we used the Dutch version of the parent-reported SDQ.13-17 This 25-item questionnaire assesses psychological adjustment of children and youths and provides five subscales: emotional symptoms, conduct problems, hyperactivity and inattention, peer relationship problems, and prosocial behavior. The Total difficulties score is the sum of the first four subscale scores (i.e. without prosocial behavior), a higher score reflects more problems. Secondary outcomes Sleep problems Children wore a wrist-worn actigraph (ActiGraph wGT3X-BT, Pensacola, FL, USA) for seven consecutive days twice: once during hydrocortisone and once during placebo (Figure 1). The parent kept an additional sleep diary. To assess subjective sleep quality and sleep disturbances, we used the Sleep Disturbance Scale for Children (SDSC).18 This questionnaire contains 26 items and yields six subscales and a Total sleep score: a higher score reflects more problems. Hunger score To measure dexamethasone-induced feeling of hunger, we used an Eating Thermometer (ET): a visual analogue scale to indicate hunger.19,20 Four different thermometers were administered: to indicate average, least and worst hunger the past 24 hours, and fasting feeling of hunger. The scale ranged from 0 (no hunger at all) to 10 (terrible hunger). Health-related quality of life The Pediatric Quality of Life Inventory (PedsQL), a 21- (for toddlers) or 23-item questionnaire, was used to assess HRQoL.21 A higher score reflects a better HRQoL in the child. Parental distress We used the Distress Thermometer for parents (DT-P) to assess parental distress.22 Parents were asked to rate their overall distress from 0 (no distress) to 10 (extreme distress). Adverse events All adverse events, defined as any change in condition between the very first dose and 16 days after the last dose of study medication, were recorded consistent with the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.23
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