Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Sep;38(9):1595-1602.
doi: 10.1080/03007995.2022.2096333. Epub 2022 Jul 11.

Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study

Brenda M Y Leung  1 , Priya Srikanth  2 , Barbara Gracious  3   4 , Irene E Hatsu  5 , Gabriella Tost  2 , Valerie Conrad  2 , Jeanette M Johnstone  2   6 , L Eugene Arnold  7
Affiliations
Randomized Controlled Trial

Paediatric adverse event rating scale: a measure of safety or efficacy? Novel analysis from the MADDY study

Brenda M Y Leung et al. Curr Med Res Opin. 2022 Sep.

Abstract

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.

Keywords: ADHD; PAERS; adverse events; micronutrients.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Mean Combined PAERS score by PCA Category change over time by treatment group.
See this image and copyright information in PMC

References

    1. Thomas R, Sanders S, Doust J, et al. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015;135(4):e994–1001. - PubMed
    1. Pliszka S. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894–921. - PubMed
    1. Baweja R, Hale DE, Waxmonsky JG. Impact of CNS stimulants for Attention-Deficit/hyperactivity disorder on growth: epidemiology and approaches to management in children and adolescents. CNS Drugs. 2021;35(8):839–859. - PubMed
    1. Catalá-López F, Hutton B, Núñez-Beltrán A, et al. The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: a systematic review with network Meta-analyses of randomised trials. PLoS One. 2017;12(7):e0180355. - PMC - PubMed
    1. Johnstone JM, Leung B, Gracious B, et al. Rationale and design of an international randomized placebo-controlled trial of a 36-ingredient micronutrient supplement for children with ADHD and irritable mood: the micronutrients for ADHD in youth (MADDY) study. Contemp Clin Trials Commun. 2019;16:100478. - PMC - PubMed

Publication types

Associated data