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

Recruiting now · Not applicable

Conditions studied: Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood

In brief

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.

Key facts

Study ID

NCT06133231

Run by

Oregon Health and Science University

People needed

30

Starts

2024-01-06

Expected to finish

2026-01-01

Last updated by the study team

2025-01-16

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%)

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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