RECRUITING

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

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Conditions

Attention Deficit/Hyperactivity DisorderEmotional DysfunctionIrritable Mood

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-06
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06133231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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
  3. * Able and willing to swallow up to 8 pills per day
  4. * Medication free for 2 weeks prior to baseline
  5. * Willing to use Tasso® OnDemand SST+ to collect blood at home and filter cards to provide urine samples
  6. * Able to communicate in English
  7. * Parent/care giver identifies child as Black/African American or Hispanic/Latina/o or more than one race (target 70-100%)
  1. * Neurological disorders
  2. * Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
  3. * Psychiatric conditions requiring hospitalization
  4. * Allergy to any supplement ingredient
  5. * In people with a uterus: sexually active, pregnancy or suspected pregnancy
  6. * Abnormality of mineral metabolism

Contacts and Locations

Study Contact

Jeanette Johnstone, PhD
CONTACT
503-893-5873
jojeanet@ohsu.edu

Principal Investigator

Jeanette Johnstone, PhD
PRINCIPAL_INVESTIGATOR
Oregon Health and Science University

Study Locations (Sites)

Oregon Health & Science University
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

  • Jeanette Johnstone, PhD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-06
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-06
Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

  • Attention Deficit/Hyperactivity Disorder
  • Emotional Dysfunction
  • Irritable Mood