NCT06133231

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit/Hyperactivity Disorder
• Emotional Dysfunction
• Irritable Mood

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants	Participants will take 2-4 capsules of EMP+ Advanced per day (max 8 capsules) for eight weeks.

Timeline

• Start date: 2024-01-06
• Primary completion: 2025-09-01
• Completion: 2026-01-01
• First posted: 2023-11-15
• Last updated: 2025-01-16

Locations

1 site across 1 country: United States