Clinical trial NCT06133231: Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Emotional Dysfunction
Irritable Mood
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-11-15
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility of using multinutrient intervention with previously under-represented populations
Primary purpose: OTHER

Brief 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.

Eligibility 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

Primary outcomes:
measure: Feasibility measured by count of consumed multinutrients
timeFrame: Week 4, Week 8
measure: Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
timeFrame: Week 8
Secondary outcomes:
measure: Feasibility of Capillary Blood Collection
timeFrame: Baseline
measure: Acceptability of Capillary Blood Collection
timeFrame: Baseline
measure: Feasibility of Collecting 24-hour Urine
timeFrame: 4x on one day only to reflect 24-hour urine collection - Baseline, Week 8
measure: Acceptability of Collecting 24-hour Urine
timeFrame: Week 8
measure: Child and Adolescent Symptom Inventory (CASI-5)
timeFrame: Baseline, Week 4, Week 8
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 4, Week 8
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Baseline, Week 8
measure: Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)
timeFrame: Baseline and Week 8
measure: Parent Target Problem (PTP) using Ecological Momentary Assessment (EMA)
timeFrame: Baseline to Week 8, daily
measure: Feasibility of Collecting Real-Time EMA Parent Target Problem (PTP)
timeFrame: Week 4, Week 8
measure: Acceptability of Collecting Real-Time EMA Parent Target Problem (PTP)
timeFrame: Week 8
measure: Pediatric Adverse Events Rating Scale (PAERS)
timeFrame: Baseline, Week 4, Week 8
measure: Reasons for Dropout
timeFrame: Before week 7
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jeanette Johnstone, PhD
role: PRINCIPAL_INVESTIGATOR
References: