Optimizing Research With Diverse Families

NOT_YET_RECRUITING

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Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of micronutrients 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

Study Start (Actual) 2024-09

Primary Completion (Estimated) 2025-07

Study Completion (Estimated) 2026-01

Enrollment (Estimated) 30

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Portland, Oregon, United States

Eligibility Criteria

Description

Inclusion Criteria:

* Children, ages 6-12 years at enrollment, with suspected or definite ADHD based on parent report in a family that identifies as Black or Hispanic
* Meet criteria on CASI-5 ADHD scale (6+ symptoms ≥ 2), occurring in \>1 setting, plus one impairing irritability symptom (≥2) from ODD or DMDD subscale
* Able and willing to swallow 9-12 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 females: sexually active, pregnancy or suspected pregnancy
* Abnormality of mineral metabolism

Ages Eligible for Study: 6 Years to 12 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-06-12
First Submitted that Met QC Criteria2023-11-10
First Posted2023-11-15

Study Record Updates

Last Update Submitted that Met QC Criteria2024-06-06
Last Update Posted2024-06-07
Last Verified2024-06