Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT06133231

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

Led by Oregon Health and Science University · Updated on 2025-01-16

30

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 17 years at enrollment with suspected or confirmed ADHD based on parent report
  • Majority of participants identify as Black, Hispanic, or multicultural families
  • Meet criteria on Child and Adolescent Symptom Inventory-5 (CASI-5) ADHD scale with 6 or more symptoms in 2 or more settings
  • Have at least one impairing irritability symptom from Oppositional Defiant Disorder or Disruptive Mood Dysregulation Disorder subscales
  • Able and willing to swallow up to 8 capsules per day
  • Medication-free for 2 weeks prior to baseline
  • Willing to collect blood and urine samples at home using specified devices
  • Able to communicate in English
  • Parent or caregiver identifies child as Black/African American, Hispanic/Latina/o, or more than one race (target 70-100%)
Not Eligible

You will not qualify if you...

  • Presence of neurological disorders
  • Medical conditions such as cancer, kidney or liver disease, diabetes, or hyperthyroidism
  • Psychiatric conditions requiring hospitalization
  • Allergy to any ingredient in the supplement
  • For participants with a uterus: sexually active, pregnant, or suspected pregnancy
  • Abnormal mineral metabolism

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

J

Jeanette Johnstone, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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