Feasibility and acceptability of multinutrient intervention for ADHD in diverse families
Official title: 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
Run by Oregon Health and Science University · NCT06133231 · Data updated 2026-11-12
This study is trying to see if a new multinutrient treatment for children with ADHD is acceptable and easy to use for Black and Hispanic families.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | January 6, 2024 |
| Main results expected | September 2025 |
| Study ends | January 2026 |
| Registry record updated | January 16, 2025 |
| Trial ID | NCT06133231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6-17 years with suspected or confirmed ADHD from Black or Hispanic families.
✕Probably not a fit
Patients with neurological disorders or significant medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility and acceptability of recruiting Black and Hispanic families for an open-label clinical trial involving a multinutrient intervention aimed at children with ADHD. Over an 8-week period, participants will provide real-time data on their child's behavior and collect biospecimens at home to explore potential biomarkers. The study aims to refine recruitment methods and assess the intervention's acceptability among racially and ethnically diverse participants. A total of 30 families will be involved in this innovative approach to pediatric ADHD treatment.
Why it matters
Potential benefit: If successful, this study could provide insights into effective nutritional interventions for ADHD in diverse populations.
How similar studies have gone: While there is limited data on similar multinutrient interventions specifically targeting diverse populations, previous studies have shown promise in nutritional approaches for ADHD.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Oregon Health & Science University
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: Jeanette Johnstone, PhD — Oregon Health and Science University
- Study coordinator: Jeanette Johnstone, PhD
- Email: jojeanet@ohsu.edu
- Phone: 503-893-5873
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.