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Feasibility and Acceptability Study of Multinutrients for ADHD and Emotional Dysfunction

This study, called FAST, is looking at how practical and acceptable it is to use a special blend of vitamins, minerals, amino acids, and antioxidants called EMP+ Advanced in children and teens. It's for those aged 6 to 17 who have suspected or definite Attention Deficit/Hyperactivity Disorder (ADHD), emotional difficulties, or irritable moods. The study is specifically recruiting families who identify as Black, Hispanic, or multicultural. You would take 2-4 capsules of EMP+ Advanced daily for eight weeks. Researchers will measure how much of the multinutrient is consumed and ask about your experience with it. The study aims to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an open-label study, meaning everyone knows what treatment they are receiving. It plans to enroll 30 participants to evaluate the intervention.
What's involved
Participants will take 2-4 capsules of EMP+ Advanced per day for eight weeks. Parents will also report on their child's behavior and collect at-home blood and urine samples.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 4 and Week 8, indicating the duration of active participation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06133231

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

Recruiting
NAAges 6–17Interventional
Oregon Health and Science University
~30 participants
Updated 2025-01-16 on ClinicalTrials.gov
What's tested:Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility measured by count of consumed multinutrients
Measured over Week 4, Week 8
+1 more outcome measured

Conditions

Attention Deficit/Hyperactivity Disorder
Emotional Dysfunction
Irritable Mood

Explore related trials

Attention Deficit Hyperactivity DisorderIrritabilityRetinal dysfunction

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

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

Who to contact

Jeanette Johnstone, PhD
[email protected]
503-893-5873
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility measured by count of consumed multinutrientsWeek 4, Week 8

    Feasibility will be determined based on consumption of the number of capsules determined to be beneficial based on parent and child report of symptom improvement or side effects, typically 2-4 capsules per day (up to max of 8) and achieved when greater than or equal to 75% of recommended doses have been consumed as measured at week 4 and at week 8 by pill count.

  • Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scaleWeek 8

    Acceptability of taking the multinutrients will be measured through 7 questions with a 6-point Likert scale (range: Strongly Disagree to Strongly Agree). Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking the capsuled multinutrients is acceptable, at or above the "Agree" range - scores of 5 or 6.