Feasibility and Acceptability Study to Optimize Research Methods in a Multinutrient Trial for Diverse Children With ADHD and Emotional Dysregulation

What this Trial Is About

Researchers are exploring how to recruit and work with Black and Hispanic families in a study of children aged 6 to 17 years with ADHD and emotional difficulties. This open-label study focuses on testing a multinutrient supplement and aims to see how practical and acceptable it is to collect real-time parent-reported behavior data and at-home biological samples. The study involves 30 racially and ethnically diverse children to improve research methods for this population. Participants will take an active multinutrient supplement daily for eight weeks, with doses ranging from 2 to 4 capsules per day, up to a maximum of 8 capsules. The study will collect ecological momentary assessment (EMA) data on the child's behavior, as reported by parents. Blood and urine samples will be collected at home using specific devices and filter cards to explore potential biological markers. The intervention is open-label, meaning all participants receive the supplement. During the study, researchers will track multinutrient consumption at weeks 4 and 8 and assess acceptability with a rating profile at week 8. Additional measures include feasibility and acceptability of blood and urine collection, symptom inventories, clinical global impressions, dietary assessments, and daily parent-reported target behavior monitoring. Safety and adverse events will be recorded throughout. Participation lasts eight weeks, with data collected at multiple points to evaluate both the intervention and research methods.

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