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

Description

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

Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood

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Study Overview

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Study Details

Study overview

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.

A Feasibility and Acceptability Study (FAST) to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation

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

Condition
Attention Deficit/Hyperactivity Disorder
Intervention / Treatment

-

Contacts and Locations

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%)
  • * 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

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Oregon Health and Science University,

Jeanette Johnstone, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

2026-01