Micronutrients and emotion dysregulation in children: single case research design

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 can have, and no swallowing capsules is necessary, all reasons why they might be a more convenient alternative option for children. Participants are asked to take one Lightning Stik a day; however, as anecdotal reports have previously reported headaches in the first few days of taking the Lightning Stiks, participants are advised to start with only ½ a straw in this study for the first two days. The proposed study will investigate the short and long-term effects of the Lightning Stiks using a two-arm withdrawal design, where n=40 participants will be randomised to two groups (20:20) to start the nutrients right away or have the start delayed by one month. Group 1 will take the intervention for four weeks before it will be withdrawn for four weeks, and then reinstated for another 12 weeks. Group 2 will have a delayed 4-week start, then take the intervention for four weeks before it will be withdrawn for four weeks and finally reinstated for another 12 weeks. Randomisation will be determined in blocks of four. The participants are eligible for the study when they display moderate to severe symptoms of emotion dysregulation/irritability, which will be assessed using a questionnaire during the screening phase of the study. There will be 5 study phases in total, and participation for each participant will last about 6-7 months. Every two weeks, parents will answer various psychometric questionnaires assessing their children’s behaviour, including hyperactivity/impulsivity, inattention, emotion dysregulation, irritability, sleep, side effects, and diet. In addition, once a month, the researcher will meet in person with both the parent and the child to collect data on emotional and behavioural dysregulation and irritability, mood, sleep, and social behaviour. To see if the potential changes in the children’s behaviour impacts the parent’s wellbeing and vice versa, parents will fill out a measure assessing symptoms of depression, anxiety, and stress every four weeks. At the end of each month when taking the intervention, the participants will be asked how much product they have left (via an online questionnaire). Since every participants receives 30 pouches of product for the month, this information will be used to calculate adherence. Ingredient list (active intervention): Servings per Container: 30 Serving Size: 1 Stik (2.6 g) Amount per Serving: Vitamin A (retinyl palmitate) 0.03 mg Vitamin C (ascorbic acid) 10.00 mg Vitamin D (cholecalciferol) 0.60 mcg Vitamin E (d-alpha tocopheryl succinate) 4.00 mg Thiamin (thiamin mononitrate) 0.30 mg Riboflavin 0.23 mg Niacin (niacinamide) 1.50 mg Vitamin B6 (pyridoxine hydrochloride) 0.60 mg Folic Acid 0.02 mg Vitamin B12 (cyanocobalamin) 0.02 mg Biotin 0.02 mg Pantothenic Acid (d-calcium pantothenate) 0.35 mg Calcium (as chelate) 22.00 mg Iron (as chelate) 0.23 mg Phosphorus (as chelate) 14.00 mg Iodine (from Atlantic kelp) 3.40 mcg Magnesium (as chelate) 10.00 mg Zinc (as chelate) 0.80 mg Selenium (as chelate) 3.40 mcg Copper (as chelate) 0.12 mg Manganese (as chelate) 0.16 mg Chromium (as chelate) 0.01 mg Molybdenum (as chelate) 2.40 mcg Potassium (as chelate) 4.00 mg Proprietary Blend (27.72 mg): Choline Bitartrate, DL-Phenylalanine, Vanadium Chelate, Citrus Bioflavonoids, Inositol, L-Glutamine, L-Methionine, Boron Chelate, Grape Seed Extract, Ginkgo Biloba Leaf, Germanium Sesquioxide, Nickel Chelate