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

NCT06133231 | Recruiting

• 1 other identifier: 00024336
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder; Emotional Dysfunction; Irritable Mood

Outcome Measures

Primary Outcomes (2)

• Feasibility measured by count of consumed multinutrients

  Feasibility will be determined based on consumption of the number of capsules determined to be beneficial based on parent and child report of symptom improvement or side effects, typically 2-4 capsules per day (up to max of 8) and achieved when greater than or equal to 75% of recommended doses have been consumed as measured at week 4 and at week 8 by pill count.

  Week 4, Week 8

• Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale

  Acceptability of taking the multinutrients will be measured through 7 questions with a 6-point Likert scale (range: Strongly Disagree to Strongly Agree). Acceptability will be achieved if greater than or equal to 70% of children and parents report that taking the capsuled multinutrients is acceptable, at or above the "Agree" range - scores of 5 or 6.

  Week 8

Secondary Outcomes (13)

• Feasibility of Capillary Blood Collection

  Baseline

• Acceptability of Capillary Blood Collection

  Baseline

• Feasibility of Collecting 24-hour Urine

  4x on one day only to reflect 24-hour urine collection - Baseline, Week 8

• Acceptability of Collecting 24-hour Urine

  Week 8

• Child and Adolescent Symptom Inventory (CASI-5)

  Baseline, Week 4, Week 8

Study Arms (1)

Multinutrient

EXPERIMENTAL

All participants will take the active multinutrient treatment

Dietary Supplement: Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants

Interventions

Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants DIETARY_SUPPLEMENT

Participants will take 2-4 capsules of EMP+ Advanced per day (max 8 capsules) for eight weeks.

Also known as: EmpowerPlus (EMP+) Advanced

Multinutrient

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Minerals; Amino Acids; Antioxidants

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Amino Acids, Peptides, and Proteins; Biological Factors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Protective Agents; Physiological Effects of Drugs; Specialty Uses of Chemicals

Study Officials

• Jeanette Johnstone, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Johnstone, PhD

CONTACT

503-893-5873; jojeanet@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility of using multinutrient intervention with previously under-represented populations

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: November 15, 2023
• Study Start: January 6, 2024
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

US (1)