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Recruiting NCT06133231

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

No phase Interventional Attention Deficit/Hyperactivity Disorder Emotional Dysfunction Irritable Mood

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants.
Who it may be relevant to
Registry conditions: Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Feasibility measured by count of consumed multinutrients [Time frame: Week 4, Week 8]
  • Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale [Time frame: Week 8]
Secondary outcome measures (12)
  • Feasibility of Capillary Blood Collection [Time frame: Baseline]
  • Acceptability of Capillary Blood Collection [Time frame: Baseline]
  • Feasibility of Collecting 24-hour Urine [Time frame: 4x on one day only to reflect 24-hour urine collection - Baseline, Week 8]
  • Acceptability of Collecting 24-hour Urine [Time frame: Week 8]
  • Child and Adolescent Symptom Inventory (CASI-5) [Time frame: Baseline, Week 4, Week 8]
  • Clinical Global Impression - Improvement (CGI-I) [Time frame: Week 4, Week 8]
  • Clinical Global Impression - Severity (CGI-S) [Time frame: Baseline, Week 8]
  • Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24) [Time frame: Baseline and Week 8]
  • Parent Target Problem (PTP) using Ecological Momentary Assessment (EMA) [Time frame: Baseline to Week 8, daily]
  • Feasibility of Collecting Real-Time EMA Parent Target Problem (PTP) [Time frame: Week 4, Week 8]
  • Acceptability of Collecting Real-Time EMA Parent Target Problem (PTP) [Time frame: Week 8]
  • Pediatric Adverse Events Rating Scale (PAERS) [Time frame: Baseline, Week 4, Week 8]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT06133231 · 00024336

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗