Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study
Brenda M Y Leung1, Priya Srikanth2, Barbara Gracious3,4
1Faculty of Health Sciences, University of Lethbridge, Alberta Canada.
Insights
A broad-spectrum multinutrient supplement improved anxiety symptoms in children with ADHD, with no increase in adverse events compared to placebo. The Pediatric Adverse Event Rating Scale (PAERS) proved useful for assessing ADHD behaviors.
Area of Science:
- Pediatric Psychology
- Nutritional Psychiatry
- Clinical Trials Methodology
Background:
- Attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation are common in children.
- Micronutrient supplementation is being explored as a potential treatment adjunct for ADHD.
- The Pediatric Adverse Event Rating Scale (PAERS) is used to measure adverse events in pediatric populations.
Purpose of the Study:
- To assess the treatment sensitivity of the PAERS in measuring adverse events in children with ADHD and emotional dysregulation.
- To evaluate the efficacy and safety of a broad-spectrum multinutrient treatment compared to placebo in the Micronutrients for ADHD in Youth (MADDY) study.
- To determine if the PAERS can serve as an adjunct outcome measure for ADHD behaviors.
Main Methods:
- The MADDY study was an 8-week, multi-site randomized clinical trial involving children aged 6-12 years with ADHD and emotional dysregulation.
- Principal component analysis identified 14 PAERS items relevant to ADHD symptoms and emotional dysregulation.
- A combined score was created based on symptom presence, functional impairment, and severity; mean score changes from baseline to week 8 were analyzed using intention-to-treat (ITT) and per-protocol samples.
Main Results:
- The micronutrient group showed a significantly greater decrease in the mean anxiety combined score compared to the placebo group (ITT: -0.36, p=.03; per-protocol: -0.48, p=.005).
- Baseline PAERS symptoms were similar between groups, with ADHD symptoms and irritable symptoms being most prevalent.
- The multinutrient supplement did not result in more adverse events than placebo.
Conclusions:
- Broad-spectrum multinutrient supplementation appears to be a safe intervention for children with ADHD.
- The PAERS may be a valuable tool for assessing adverse events and can serve as an adjunct outcome measure for ADHD-related behaviors.
- The findings support the potential role of micronutrients in managing anxiety symptoms associated with ADHD.
Objective:
The Pediatric Adverse Event Rating Scale (PAERS) measured adverse events of children aged 6-12 years with ADHD and emotional dysregulation in the Micronutrients for ADHD in Youth (MADDY) study, an eight week multi-site randomized clinical trial of a broad-spectrum multinutrient treatment. Treatment sensitivity of the PAERS was assessed by calculating the treatment difference in change of the item scores from baseline to end of the RCT.
Methods:
Principal component analysis retained 14 "adverse events" (out of 43 in the PAERS) that reflected ADHD symptoms and emotional dysregulation and was used to group the variables of interest. A combined score ranging from 0 to 5 was created based on symptom presence, functional impairment, and severity. Mean score change was calculated from baseline to week 8 by treatment (multinutrient vs placebo) with intention-to-treat and per-protocol samples. The study has been registered on clinicaltrials.gov as Micronutrients for ADHD in Youth (MADDY) Study, trial registration # NCT03252522 (https://clinicaltrials.gov/ct2/show/NCT03252522).
Results:
The 126 children in the ITT sample had a mean age of 9.8 (SD = 1.7), with majority (73%) male, and 72% diagnosed with ADHD prior to the study screening. Baseline presence of PAERS symptoms was similar between treatment groups: the highest proportion was ADHD symptoms, followed by Irritable symptoms. The micronutrient group showed a greater decrease (improvement) in the mean anxiety combined score than the placebo group with a between-group difference in change of -0.36 (95% CI: -0.67, -0.04; p = .03) with ITT data and -0.48 (95% CI: -0.81, -0.15; p = .005) with per-protocol (n = 93) data.
Conclusion:
The multinutrient supplement did not result in more adverse events than placebo, suggesting it is a safe intervention. In addition to assessing actual adverse events, the PAERS may be a useful adjunct outcome measure for ADHD behaviors.
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