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

Johnstone, Jeanette M.; Leung, Brenda; Gracious, Barbara L.; Perez, Leanna; Tost, Gabriella; Savoy, Andrew; Hatsu, Irene; Hughes, A.J.; Bruton, Alisha; Arnold, L. Eugene

doi:10.1016/j.conctc.2019.100478

Cited by 18 publications

(7 citation statements)

References 55 publications

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“…In summary, open label pilot studies and two RCTs provide promising data for multinutrient supplementation in ADHD populations. Replication at other geographical centers is underway, with a larger trial of emotionally dysregulated kids with ADHD involving three centers (two in the US and one in Canada) completed in July 2020 (Johnstone et al, 2019); study results are expected in 2021.…”

Section: Adhdmentioning

confidence: 99%

Nutrition Provides the Essential Foundation for Optimizing Mental Health

Rucklidge

Johnstone

Kaplan

2021

Evidence-Based Practice in Child and Adolescent Mental Health

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Although current evidence confirms the importance of diet for mental health, many psychologists avoid discussing dietary intake with clients, questioning whether this information is within their scope of practice. This article provides psychologists with a review focused on the connection between what we eat and how we feel. Eating a healthy, whole-foods-based diet is an important tool to promote mental health recovery and maintenance. We begin by reviewing several mechanisms by which nutrients maximize brain health, including enabling metabolic reactions to occur, supporting mitochondrial function, reducing inflammation and assisting with detoxification. Understanding the vital role of nutrients for brain health will aid clients in understanding the importance of optimizing their intake of a range of nutrients in order to maximize their mental health: no single nutrient is sufficient. Next, we summarize evidence relating diet to mental health, followed by a consideration of circumstances that may contribute to a client requiring additional nutrients, such as chronic stress, medication use, individual biochemistry, and consuming nutrientdepleted food. The evidence base for treating psychological problems in children with supplementary nutrients is then reviewed, and a case study of a child whose self-regulatory skills improved with broad-spectrum multinutrients is used to illustrate this treatment. The breadth and consistency of the research highlights the importance of children receiving a good foundation of nutrients for optimizing brain health. Finally, we offer practical suggestions for psychologists to incorporate this information into their clinical practice and discuss these suggestions within the context of informed consent.

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Section: Adhdmentioning

confidence: 99%

Nutrition Provides the Essential Foundation for Optimizing Mental Health

Rucklidge

Johnstone

Kaplan

2021

Evidence-Based Practice in Child and Adolescent Mental Health

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“…The composite CASI score is the planned primary outcome of an RCT currently underway. The Micronutrients for ADHD in Youth (MADDY) study is an 8-week, fully blinded clinical trial recruiting children aged 6-12 years with ADHD and emotional dysregulation ( Johnstone et al 2019) to investigate a broad-spectrum micronutrient supplement (NCT03252522). The MADDY study's primary outcome, designed a priori as a composite score, comprises the five subscales from the CASI-5 (Gadow and Sprafkin 2015), as described in this article.…”

Section: Adhd and Emotional Dysregulation 169 Discussionmentioning

confidence: 99%

Development of a Composite Primary Outcome Score for Children with Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation

Johnstone

Leung

Srikanth

et al. 2020

Journal of Child and Adolescent Psychopharmacology

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Objective: Study goals were to (1) provide a rationale for developing a composite primary outcome score that includes symptom severity for attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation, plus symptom-induced impairment; (2) demonstrate weighting methods to calculate the composite score using a sample of children diagnosed with ADHD and aggression; and (3) identify the optimal weighting method most sensitive to change, as measured by effect sizes. Methods: We conducted secondary data analyses from the previously conducted Treatment of Severe Childhood Aggression (TOSCA) study. Children aged 6-12 years were recruited through academic medical centers or community referrals. The composite primary outcome comprised the ADHD, oppositional defiant disorder, disruptive mood dysregulation disorder, and peer conflict subscales from the Child and Adolescent Symptom Inventory (CASI), a DSM (Diagnostic and Statistical Manual)-referenced rating scale of symptom severity and symptom-induced impairment. Five weighting methods were tested based on input from senior statisticians. Results: The composite score demonstrated a larger (Cohen's d) effect size than the individual CASI subscales, irrespective of the weighting method (10%-55% larger). Across all weighting methods, effect sizes were similar and substantial: approximately a two-standard deviation symptom reduction (range: -1.97 to -2.04), highest for equal item and equal subscale weighting, was demonstrated, from baseline to week 9, among all TOSCA participants. The composite score showed a medium positive correlation with the Clinical Global Impressions-Severity scores, 0.46-0.47 for all weighting methods. Conclusions: A composite score that included severity and impairment ratings of ADHD and emotional dysregulation demonstrated a more robust pre-post change than individual subscales. This composite may be a more useful indicator of clinically relevant improvement in heterogeneous samples with ADHD than single subscales, avoiding some of the statistical

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“…This qualitative study was a substudy of the Micronutrients for ADHD in Youth (MADDY) study, a three‐site fully‐blinded, randomized controlled trial conducted at the University of Lethbridge, Alberta, Canada; Oregon Health & Science University, Portland, Oregon; and The Ohio State University, Columbus, Ohio. Children aged 6 to 12 years were randomized to a multinutrient supplement (containing all known vitamins and essential minerals, with some antioxidants and amino acids) or a placebo for 8 weeks, followed by an 8‐week open‐label period (Johnstone et al, 2019, 2021). Parents whose children were enrolled in the MADDY study were invited to participate in the qualitative study.…”

Section: Methodsmentioning

confidence: 99%

Parents' priorities and preferences for treatment of children with ADHD: Qualitative inquiry in the MADDY study

Leung

Bruton

et al. 2022

Child

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Background: Parents' lived experiences of having a child with ADHD may shape their decision making regarding ADHD treatment options for their child. The aim of this study was to explore parents' experiences of living with a child with ADHD in the family and how their experiences influence their perspectives on treatment preferences and priorities.Methods: A phenomenological qualitative design was used. Semistructured interviews were conducted with parents of children with ADHD who were enrolled in a multisite randomized controlled trial. Interviews were transcribed verbatim, and transcripts at each site were double coded. Initial codes were derived directly from the text. Qualitative data were analysed with an inductive approach.Results: Twenty-three parents were interviewed: eight from Alberta, Canada; eight from Portland, Oregon, USA; and seven from Columbus, Ohio, USA. Among the parents, 69% were married, 86% completed college education and 52% reported household income over $80,000. Among the children, the mean age was 9.6 years (SD = 1.8 years), 78% were boys and 48% were never medicated for their ADHD.Two major themes emerged from the analysis. Theme 1 was 'impact of ADHD on families within and outside the home' with the following subthemes: 'reconfiguring the home life', 'trial-and-error of accommodations at school' and 'responding to social pressures to fit in'. Theme 2 was 'enabling appropriate and accessible treatments for families' with the following subthemes: 'finding the "right fit" with professionals and treatments' and 'factors influencing inequitable access to treatments'.Conclusions: Parents described shared experiences and identified similar barriers, preferences and priorities for ADHD treatments regardless of demographic differences by site. Families desired access to family-centred, multimodal approaches to ADHD treatment. Further research is needed to identify the specific structural changes to healthcare, services and policies that will better support this approach.

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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

Cited by 18 publications

References 55 publications

Nutrition Provides the Essential Foundation for Optimizing Mental Health

Nutrition Provides the Essential Foundation for Optimizing Mental Health

Development of a Composite Primary Outcome Score for Children with Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation

Parents' priorities and preferences for treatment of children with ADHD: Qualitative inquiry in the MADDY study

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