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

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 limitations associated with multiple comparisons. Among the five similar weighting methods, the two best appear to be the equal item and equal subscale weighting methods.

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.

BACKGROUND: Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic neurodevelopmental disorder affecting up to 9% of children and substantial numbers of adults. Existing pharmacologic treatments often improve symptoms, but concerns exist over side effects, stigma, potential long-term health effects, and residual irritability, often treated with adjunctive antipsychotics. To address public and clinician demand for non-pharmacologic evidence-based treatments, this study will examine efficacy of a 36-ingredient micronutrient (vitamin/mineral) supplement as treatment for children with ADHD and irritability. METHODS: An international team of experts in ADHD, mood dysregulation, nutrition, epidemiology, and clinical trials conferred to develop/refine a protocol powered to detect a medium effect. The study will employ a fully-blind randomized controlled trial (RCT) design, comparing the micronutrient supplement to matched placebo in 135 children aged 6-12 with ADHD symptoms and irritability, based on the parent-rated Child and Adolescent Symptom Inventory-5 (CASI-5). Irritability will be measured by at least one symptom of oppositional defiant disorder (ODD) or disruptive mood dysregulation disorder (DMDD). Based on research suggesting an irritable ADHD subtype, the primary outcome will be a composite score comprised of the CASI-5 subscales: ADHD, ODD, DMDD, and the Peer Conflict Scale, which assesses anger and aggression perpetrated towards peers. Participants will provide biological samples (blood, urine, saliva, hair and stool) to explore the micronutrients' mechanisms of action. DISCUSSION: This study is the first adequately powered RCT in North America to examine both behavioral responses to, and biological mechanisms of, micronutrients for ADHD and irritability in children. If found efficacious, broad-spectrum micronutrients, given at therapeutic doses, may provide an evidence-based alternative to prescription medications for ADHD and associated irritability. TRIAL REGISTRATION: NCT03252522. Registered 26 July 2017.

The Relationship between Food Insecurity and Symptoms of Attention-Deficit Hyperactivity Disorder in Children: A Summary of the Literature.

Food insecurity is a major public health concern characterized by an individual or household lacking access to adequate food to support a healthy lifestyle. Food insecurity has been associated with predisposing or exacerbating mental health symptoms in children. However, the evidence is scarce with regards to Attention-Deficit Hyperactivity Disorder (ADHD) symptoms in children. The purpose of this review is to summarize and identify gaps in the existing literature, as well as to explore associations between food insecurity and symptoms of childhood ADHD. Literature for this review was pulled from Ovid MEDLINE and PubMed library databases, with a focus on food insecurity, food insufficiency, hunger, and ADHD symptoms such as inattention, hyperactivity, and impulsivity in children. The limited evidence to date shows a predictive and inverse relationship between childhood experience of food insecurity and symptoms of ADHD, with lasting impacts into adulthood. Evidence exists to hypothesize that childhood food insecurity is associated with predisposing or exacerbating ADHD symptoms in children, yet the literature needed to confirm this relationship is scarce and utilizes inconsistent methodology. Future research is needed to further characterize this complex relationship and inspire community or public health interventions addressing food insecurity in children with ADHD. Additionally, it may be clinically useful to routinely screen for food insecurity when assessing pediatric ADHD symptoms.

The Role of Dietary Patterns in Mood Disorders: Prospective Research in Youth Populations.

Childhood mood disorders, including depression and bipolar spectrum disorders, represent serious public health concerns and often extend into adulthood. Due to increasing rates of a mood disorder diagnosis, and its accompanying risk of suicide, identification and management in childhood and adolescence is critical. Yet, fully effective and safe treatment options are lacking for child-onset mood disorders. Research investigating relationships between nutrition and psychiatry is a plausible avenue to improve prevention and treatment options. Epidemiological and observational evidence exists to support a protective effect of the Mediterranean diet in mood disorder prevalence and future diagnosis. To date, the majority of research has been conducted in adult populations. Future research is needed to examine if similar dietary relationships exist within a youth mood disorder population. Additionally, increased homogeneity in assessment methods of mood disorder symptoms and dietary patterns is needed; specifically, to determine more collective conclusions via meta-analyses. Results from youth studies could be used to formulate future randomized controlled trials, health promotion programs or clinical interventions, via diet or supplement interventions, for alternative mood disorder treatment or prevention purposes.

Adolescents with at-risk eating and lifestyle behaviors are affected by after school schedules across the clinical weight spectrum.

OBJECTIVE: Evaluate adolescent lifestyle patterns to develop more effective health promotion programs. METHODS: An interview approach was employed to gain in-depth understanding of eating and activity behaviors. Adolescents aged 13-18 years (n=43) from clinically normal and obese weight categories were enrolled. Nutrient intake and food group servings were obtained from a food frequency questionnaire. RESULTS: Four participant subgroups were identified and labeled: "Idle, Engaged, Balanced and Working." "Idle" adolescents were sedentary, sometimes napped, and often snacked after dinner. "Engaged" adolescents participated in extra-curricular activities for the majority of their after school hours. "Balanced" adolescents participated in a single after-school activity followed by sedentary time; they consumed meals consistently and often snacked after dinner. "Working" adolescents were the least sedentary with limited sleep duration and inconsistent meals; they often substituted a meal with a snack. Weight status did not differentiate subgroups effectively. CONCLUSIONS: Each group demonstrated at-risk behaviors for obesity. Future programs should consider after-school schedules and use activity and meal pattern assessments, not simply weight status, for program tailoring. PRACTICE IMPLICATIONS: Pediatric health care providers could identify at-risk behaviors through routine assessment of diet and activity patterns in combination with weight monitoring.