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

NCT ID: NCT06133231

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-06
• Study Completion Date: 2026-01-31

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.

Conditions

Attention Deficit/Hyperactivity Disorder; Emotional Dysfunction; Irritable Mood

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Multinutrient

All participants will take the active multinutrient treatment

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

EmpowerPlus (EMP+) Advanced

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jeanette Johnstone

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanette Johnstone, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeanette Johnstone, PhD

Role: CONTACT

jojeanet@ohsu.edu

503-893-5873

Facility Contacts

Jeanette Johnstone, PhD

Role: primary

jojeanet@ohsu.edu

503-893-5873

Other Identifiers

00024336

Identifier Type: -

Identifier Source: org_study_id