Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Neurological disorders
Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
Psychiatric conditions requiring hospitalization
Allergy to any supplement ingredient
Trial design
Treatments tested in this trial
- Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Oregon Health and Science University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Sponsor institution
Source ClinicalTrials.gov