Feasibility and Acceptability Study of Multinutrients in Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation

What this Trial Is About

Researchers are evaluating the feasibility and acceptability of conducting a multinutrient trial in racially and ethnically diverse children aged 6 to 17 years, primarily focusing on Black and Hispanic families. The study aims to collect real-time parent-reported child behavior data and at-home biospecimens to explore their potential as biomarkers in pediatric ADHD, emotional dysfunction, and irritable mood. It is an open-label study lasting eight weeks, designed to improve research methods for diverse populations. Participants will take 2 to 4 capsules daily of a multinutrient supplement called EMP+ Advanced, which contains 36 ingredients including vitamins, minerals, amino acids, and antioxidants, with a maximum of 8 capsules per day. The study will collect two types of biospecimens at home—blood using the Tasso® OnDemand SST+ device and urine samples on filter cards—while monitoring the intervention's acceptability and feasibility. During the study, parents will report on their child's target behavior using ecological momentary assessment (EMA) data collected in real time. Researchers will measure feasibility by counting consumed multinutrient doses at weeks 4 and 8 and assess acceptability using a 7-question profile at week 8. The study requires participants to be medication-free for two weeks prior to baseline and able to communicate in English. The total participation period is eight weeks with ongoing monitoring of adherence and behavior changes.

Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)