Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
Recruiting · NCT06133231 · Interventional (participants receive a specific treatment) · Lead sponsor: Oregon Health and Science University
View the official record on ClinicalTrials.gov →Interventions studied
Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
What this trial is about
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.
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Oregon Health & Science University - Portland, Oregon, United States