Micronutrients and emotion dysregulation in children: single case research design

INTERVENTION: Micronutrients are vitamins and minerals that have widely been studied across the globe in the context of mental health, and scientific evidence suggests that they have beneficial effects on various psychological concerns, including stress, anxiety, mood, inattention, hyperactivity/impulsivity, emotion dysregulation, and irritability. Because children often display problems with swallowing pills or taking multinutrient powder (due to the unpleasant taste and smell) as well as can often struggle with emotion dysregulation, a new modality of taking micronutrients might represent a new, more convenient way for children to take micronutrients. For those reasons, the proposed study aims to investigate whether the Lightning Stiks are an effective treatment for children between 5 and 10 years of age who struggle with emotion dysregulation and irritability. The product being tested is called EMP Lightning Stiks which come as powdered straws that use Direct‐to‐Mouth technology, meaning that all participants have to do is put the powder directly in their mouth and let it dissolve. The Lightning Stiks consist of a blend of 36 ingredients, including vitamins, minerals and amino acids. The advantage of this mode of delivery is that the doses of the ingredients are much lower than those found in capsules and well below the RDA ‐ as such, no ingredient is given in a medicinal dose. Further, all doses are well below the Tolerable Upper Intake Limit (UL), which is considered the highest amount of daily nutrient intake that is not likely to cause any adverse effects. In addition, as the Lightning Stiks are available in various flavours, such as Tropical Punch, Banana, and Sour Berry, they do not have the usual unpleasant smell or taste that micronutrients given in a capsule form CONDITION: Emotion dysregulation/irritability;Sleep;Mood;Attention Deficit/Hyperactivity Disorder (ADHD) symptoms;Oppositional Defiant Disorder (ODD) symptoms;Social behaviours; ; Emotion dysregulation/irritability ; Sleep ; Mood ; Attention Deficit/Hyperactivity Disorder (ADHD) symptoms ; Oppositional Defiant Disorder (ODD) symptoms ; Social behaviours Mental Health ‐ Other mental health disorders SECONDARY OUTCOME: Adapted Clinical Global Impressions Improvement Scale (CGI‐I Parent). The CGI‐I Parent represents the parent’s perception of change in their children’s behaviour regarding their mood, anxiety, energy, and global functioning since participating in the trial. Each item has seven responses, ranging from “very much improved” (1) to “very much worse” (7).[Every two weeks from week 2 until week 20 for group 1 or week 24 for group 2] Affective Reactivity Index (ARI) (Parent version). The ARI is a concise, parent‐rated scale assessing the child’s emotion dysregulation and irritability. It incorporates seven items that ask about feelings of irritability during the past seven days (e.g., “My child is easily annoyed by others”, “My child gets angry frequently”, “Overall, irritability causes my child problems”). How true a statement is can be scored on a 0 (not true) to 2 (certainly true) Likert scale. [Screening, baseline, and every two weeks throughout the trial from week 2 to week 20 for group 1 or week 24 for group 2] Clinical Global Impressions – Severity Scale (CGI‐S). The CGI‐S is a clinician‐rated evaluation of symptom severity by means of the question: “Considering your total clinical experience with this particular population, how impaired is the patient at this time?”.[At baseline and at the end of each switch point of either (re‐)introducing or withdrawing the active intervention. ] Parent Target Problem (PTP). The PTP asks the parents to nominate one or two of child's biggest problems, and report on their frequency, duration, impairment, and provide examples. These same 2 problems are reviewed by the clinician at every meeting and assessed for change over time.[At baseline and every four weeks throughout the trial, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2] Strengths and Difficulties Questionnaire (SDQ). The SDQ consists of 25 items across five subscales, measuring emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior in 4‐17 year old children and adolescents over the past six months.[At baseline and at week 20 for group 1 and week 24 for group 2] The Child Swanson, Nolan, and Pelham‐IV Questionnaire (SNAP‐IV). The child SNAP‐IV assesses symptoms of ADHD and oppositional defiant disorder (ODD) in children every 4 weeks. It is a parent‐ and teacher‐rating scale that has three subscales: inattention (item 1‐9), hyperactivity‐impulsivity (item 10‐18), and symptoms of ODD (item 19‐26). Each item is assessed from not at all to very much.[At baseline and every four weeks throughout the trial, i.e. at baseline, at week 4, 8, 12, 16, 20, for group 1 or week 24 for group 2] The Children’s Sleep Habits Questionnaire (CSHQ). The CSHQ is a parent‐rated measure that assesses sleep in school‐aged children. It consists of eight subscales that are both scored individually and make up a total score, identifying sleep problems. In the proposed study, only the total score will be reported, with a score of 41 (larger = more severe) representing the clinical cut‐off score for sleep problems. Larger scores indicate more severe sleeping problems. [At baseline and every two weeks throughout the trial (from week 2 to week 20 for group 1 or week 24 for group 2 ] The Measure Yourself Medical Outcome Profile (The MYMOP). Once a month, the research coordinator will meet with the parent and the child to collect information in person regarding the child’s symptoms, including hyperactivity, attention, impulsivity, emotion regulation, irritability, mood, and sleep by means of the MYMOP. Each symptom is scored on a scale from 0 to 5, with a score of 0 representing no problems, whereas a score of 5 indicates that there are lots of problems. [At baseline and every four weeks, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2.] The Side‐Effect Checklist (revised) (ASEC). The ASEC assess side effects, safety and adverse events of the intervention.[At baseline and every two weeks throughout the trial, i.e. from week 2 to week 20 for group 1 or week 24 for group 2] INCLUSION CRITERIA: 1) Participants must be between 5 and 10 years of age, 2) able to ingest 1 Lightning Stik/day, 3) need to have at least mild‐to‐moderate levels of emotional dysregulation and irritability based on the Affective‐Reactivity‐Index (ARI), represented by a total score of 3 or higher. PRIMARY OUTCOME: Clinical Global Impressions ‐ Improvement Scale (CGI‐I). The CGI‐I is a clinician‐administered scale that rates, based on all information obtained from all raters (parents, child and significant other) how much better/worse the participant is functioning since baseline across mood, stress, anxiety, and energy as well as a global impression. Each item has seven responses, ranging from “very much improved” (1) to “very much worse” (7) and helps to provide a brief, overall assessment of the participant. [Every four weeks during the trial in person, i.e. at week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2. The primary timepoint is week 20 for group 1 and week 24 for group 2.] Revised Clinician‐Rated Temper and Irritability Scale (Parent/Child Interview Guide) (CL‐ARI). The CL‐ARI is a clinician‐administered measure that assesses emotion regulation and irritability in children over the past week, asking the parent and child about temper outbursts and irritable mood, including their frequency, severity, and duration. Further, it assesses whether the child’s irritable behaviour causes problems in the family, impairments in school, and assesses potential improvements over time. Final scores range from 0 to 100.[Every four weeks, i.e. at baseline, week 4, 8, 12, 16, 20 for group 1 or week 24 for group 2. The primary timepoint is week 20 for group 1 and week 24 for group 2.]