Status:
RECRUITING
Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
Lead Sponsor:
Oregon Health and Science University
Conditions:
Attention Deficit/Hyperactivity Disorder
Emotional Dysfunction
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
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 c...
Detailed 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 accept...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06133231
Start Date
January 6 2024
End Date
January 1 2026
Last Update
January 16 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239