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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
Who can join
Ages 6 to 17 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants (dietary supplement)
Sponsor: Oregon Health and Science University · Participants: 30 · Started: Jan 6, 2024
Contact the study team
- Jeanette Johnstone, PhD · Phone: 503-893-5873
Official record on ClinicalTrials.gov — NCT06133231
Locations in the U.S.
| Oregon | Oregon Health & Science University, Portland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.