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NCT06133231NARecruiting

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

Oregon Health and Science University

Start Date

1/6/2024

Completion Date

1/1/2026

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 collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric ADHD.

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 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.

Eligibility Criteria

Age Range: 6 years to 17 years

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

Interventions

DIETARY_SUPPLEMENT

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

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Conditions

Attention Deficit/Hyperactivity DisorderEmotional DysfunctionIrritable Mood

Locations

Oregon Health & Science University

Portland, Oregon 97239

United States