Overview
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.
Description
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.
Eligibility
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