Abstract
Objective: Emotional dysregulation (ED) is increasingly recognized as a transdiagnostic construct associated with significant impairment in children, regardless of psychiatric diagnosis. Both nutritional insufficiencies and poor emotional regulation in early life are linked to adverse mental health outcomes. Evidence supports a multimodal approach to mental health, with mindfulness-based interventions (MBIs) and micronutrient supplementation emerging as promising, complementary strategies. This study aims to evaluate the individual and combined effects of a broad-spectrum micronutrient formula and an online mindfulness program on ED symptoms in children aged 6–10 years.
Method: In a randomized, placebo-controlled, 4-arm parallel-group trial, 160 6-10 year old children with ED will be assigned to one of four groups (n=40 per group): (1) micronutrients + mindfulness; (2) micronutrients + active monitoring; (3) placebo + mindfulness; (4) placebo + active monitoring. Micronutrients will be administered as a powdered formulation absorbed via the oral mucosa to enhance bioavailability and tolerability. The mindfulness intervention, MindKiwi, is an online adaptation of the UCLA ADHD mindfulness program, culturally tailored for New Zealand children. Outcomes include changes in ED symptoms, parent-reported mood and stress. Stool and saliva samples will be collected at baseline and post-intervention from a subset of participants, measuring biological markers including microbiome diversity and DNA methylation.
Conclusion: We hypothesize that children receiving any active intervention (micronutrients, mindfulness, or both) will show greater improvements in emotional dysregulation compared with placebo + active monitoring control group. We also expect micronutrients, whether delivered alone or alongside mindfulness, will be associated with increased gut microbiome diversity.