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

A Feasibility and Acceptability Study (FAST) to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation

Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric ADHD.

This study will test the feasibility of recruiting and completing a multinutrient trial with racially and ethnically diverse participants (N=30), focused on Black and Hispanic families, and the acceptability of the intervention, and refined collection methods. The 8-week, open-label, study will evaluate the feasibility and acceptability of collecting (a) real-time ecological momentary assessment (EMA) data on child's target behavior problem, as identified by parent and (b) two types of bio-specimens (blood and urine) collected at home while taking the multinutrients daily.

Inclusion Criteria:

• Children, ages 6-17 years at enrollment, with suspected or definite ADHD based on parent report in a majority of families that identify as Black or Hispanic or multicultural
• Meet criteria on Child and Adolescent Symptom Inventory-5 (CASI-5) ADHD scale (6+ symptoms ≥ 2), occurring in >1 setting, plus one impairing irritability symptom (≥2) from Oppositional Defiant Disorder (ODD) or Disruptive Mood Dysregulation Disorder (DMDD) subscale
• Able and willing to swallow up to 8 pills per day
• Medication free for 2 weeks prior to baseline
• Willing to use Tasso® OnDemand SST+ to collect blood at home and filter cards to provide urine samples
• Able to communicate in English
• Parent/care giver identifies child as Black/African American or Hispanic/Latina/o or more than one race (target 70-100%)

Exclusion Criteria:

• Neurological disorders
• Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
• Psychiatric conditions requiring hospitalization
• Allergy to any supplement ingredient
• In people with a uterus: sexually active, pregnancy or suspected pregnancy
• Abnormality of mineral metabolism