Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST) (NCT06133231) | Clinical Trial Compass
RecruitingNot Applicable
Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
United States30 participantsStarted 2024-01-06
Plain-language 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.
Who can participate
Age range6 Years – 17 Years
SexALL
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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
What they're measuring
1
Feasibility measured by count of consumed multinutrients
Timeframe: Week 4, Week 8
2
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale