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

Recruiting

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

Sponsor: Oregon Health and Science University · Participants: 30 · Started: Jan 6, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06133231

Locations in the U.S.

OregonOregon 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.