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

Oregon Health & Science University (OHSU)

Status

Enrolling

Conditions

Attention Deficit/Hyperactivity Disorder

Emotional Dysfunction

Irritable Mood

Treatments

Dietary Supplement: Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Study type

Interventional

Funder types

Other

Identifiers

NCT06133231

00024336

Details and patient eligibility

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.

Full 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 acceptability of the intervention, and refined collection methods. The 8-week, open-label, study will evaluate the feasibility and acceptability of collecting (a) real-time ecological momentary assessment (EMA) data on child's target behavior problem, as identified by parent and (b) two types of bio-specimens (blood and urine) collected at home while taking the multinutrients daily.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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