The M&M Trial: Evaluating micronutrients and mindfulness for emotional dysregulation in children: A community-based randomised placebo-controlled trial

INTERVENTION: Participants will be randomly allocated to one of four groups: 1. micronutrient + active monitoring 2. micronutrient + mindfulness 3. placebo + active monitoring 4. placebo + mindfulness The micronutrient intervention will begin first over an eight‐week period, followed by the mindfulness intervention over a six‐week period beginning week 3 of the micronutrient intervention. This initial eight‐week period is the Randomised Controlled Trial (RCT) phase and will be followed by a second eight‐week period where all participants receive micronutrients, and those who did not receive the mindfulness intervention in the RCT will now have access to the online program. Intervention 1: Micronutrient intervention. Participants will be randomly assigned to receive either a micronutrient formula or a placebo for eight weeks. After eight weeks, all participants will enter into an open‐label phase whereby all participants can choose to take the micronutrient formula for another eight weeks. Both the micronutrients and placebo are in powdered form and are to be taken orally (dissolved on the tongue) at one powdered sachet per day (2.6g). The micronutrient intervention is a blend of 36 vitamins, minerals, and amino acids. The formula, Truehope Ultimate Sticks, is being manufactured and donated by Truehope Nutritional Support Ltd. and consists of the following ingredients: Vitamin A (as retinyl palmitate) 0.03 mg, Vitamin C (ascorbic acid) 10.00mg, Vitamin D (as cholecalciferol) 0.60 mcg, Vitamin E (as d‐alpha tocopheryl succinate) 4.00 mg, Thiamin (as thiamin mononitrate) 0.30 mg, Riboflavin 0.23 mg, Niacin (as niacinamide) 1.50 mg, Vitamin B6 (as pyridoxine hydrochloride) 0.60 mg, Folic acid 0.02mg, Vitamin B12 (as cyanocobalamin) 0.02 mg, Biotin 0.02mg, Pantot CONDITION: Emotional dysregulation; ; Emotional dysregulation Mental Health ‐ Other mental health disorders PRIMARY OUTCOME: Emotion Dysregulation [Emotion Dysregulation Inventory (EDI) Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, & 6 month follow up. End of RCT (week 8) is considered the primary endpoint.] Emotion Dysregulation[Clinician‐Rated Affective Reactivity Index Baseline, Weeks 4, 8 (primary endpoint), 12, 16, and 6‐month follow up] Global improvement[Clinical Global Impressions—Improvement (CGI‐I) Weeks 4, 8 (primary endpoint), 12, 16, and 6‐month follow up] SECONDARY OUTCOME: Adverse Effects[The Side Effect Checklist (SEC; Revised) Baseline, weeks 2, 4, 6, 8, 10, 12, 14, 16, and 6‐month follow up] Attentional Difficulties and Hyperactivity Symptomology[Attention‐Deficit/Hyperactivity Disorder Rating Scale—5 (ADHD‐RS‐5) Baseline; Weeks 4, 8, 12, 16 and 6‐month follow up] Child Anxiety.[Revised Child Anxiety and Depression Scale (RCADS) Baseline. Weeks 8, 16. 6‐month follow up] Child Depression[Revised Child Anxiety and Depression Scale (RCADS) Baseline. Weeks 8, 16. 6‐month follow up] Child Sleep Habits[Children's Sleep Habits Questionnaire (CSHQ) Baseline; Weeks 8, 16, and 6‐Month follow up] Child Strengths and Difficulties[Strengths and Difficulties Questionnaire (SDQ) Baseline, Week 8, Week 16, and 6‐Month follow up] Defiant and Oppositional Behaviour[Swanson Nolan and Pelham Questionnaire‐IV (SNAP‐IV). Baseline; weeks 4, 8, 12, 16, and 6‐month follow up.] Diet Quality[Eating Behaviours Questionnaire (EBQ). Baseline; Weeks 4, 8, 12, 16, and 6‐Month follow up] DNA Methylation[Saliva sample Baseline, Week 8 (end of RCT).] Emotional Dysregulation.[Parent‐rated Affective Reactivity Inde X(ARI) Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, and 6‐month follow up] Emotional Dysregulation[Emotional Outburst Inventory (EMO‐I) Baseline; weeks 4, 8, 12, 16, and 6‐month follow up.] Gastrointestinal Symptoms[The Structured Assessment of Gastrointestinal Symptoms Scale—Pediatric version (pSAGIS) Baseline; weeks 4, 8, 12, 16, and 6‐month follow up] Impairment Severity[Clinical Global Impressions Scale—Severity Baseline] Microbiome[Stool Sample Baseline, Week 8 (end of RCT). ] Parental Anxiety[Depression, Anxiety, and Stress Scale (DASS‐21) Baseline; Weeks 4, 8, 12, 16, and 6‐month follow up] Parental Coping[Coping with Children's Negative Emotions Scale (CCNES) Baseline; weeks 8, 16 and 6‐month follow up] Parental Depression[Depression, Anxiety, and Stress Scale (DASS‐21) Baseline; Weeks 4, 8, 12, 16, and 6‐month follow up] Parental Stress[Depression, Anxiety, and Stress Scale (DASS‐21). Baseline; Weeks 4, 8, 12, 16, and 6‐month follow up] Parental: Main Concern in Regards to their Child[Parent Target Problem (PTP) Baseline, Weeks 4, 8, 12, 16, and 6‐month follow up.] Parenting mindfulness[Interpersonal Mindfulness in Parenting (IEM‐P) Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 6‐month follow up] Stress in relation to parenting[ Parenting Stress Inde X(PSI) Baseline; weeks 4, 8, 12, 16, and 6‐month follow up] INCLUSION CRITERIA: 1) Participants must meet criteria for emotional dysregulation as indicated by scores of 10 or more on the Emotion Dysregulation Inventory‐Reactivity subscale (parent report) and an average score of 1 or more on the Parent‐rated Affective Reactivity Inde X(ARI) and be assessed as moderate impairment by the Clinical Global Impression Severity (CGI‐S), 2) Must be aged between 6 and 10 years of age, 3) Participants must have English competency sufficient to correctly interpret and complete study materials and questionnaires, 4) Must be medication free (psychiatric) for >4 weeks, 5) Be able to ingest 1 powder sachet per day, 6) Have at least one parent/caregiver/whanau member able to attend 6 weekly therapy sessions online with the child and access to the internet. To ensure the data collected are valid, it is important that the same parent/caregiver is available for reviews and sessions. This will be made clear in the consent meeting.