Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Neurological disorders
Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
Psychiatric conditions requiring hospitalization
Allergy to any supplement ingredient
Trial design
Design model
Single group
Treatments tested in this trial
Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
Dietary supplementParticipants will take 2-4 capsules of EMP+ Advanced per day (max 8 capsules) for eight weeks.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: MultinutrientExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 4, Week 82
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.
Time frame
Week 8Secondary outcomes
1
Feasibility of Capillary Blood Collection
Feasibility will be measured as the frequency/percentage of children who provide capillary blood sample using the self-administered Tasso® OnDemand SST+ device. Device use will be considered feasible if greater than or equal to 70% of children provide the sample.
Time frame
Baseline2
Acceptability of Capillary Blood Collection
Child acceptability will be a 10-point Visual Analog Scale (VAS) and brief quantitative feedback regarding the blood collection process for children. Parent acceptability will be measured using a 6-point Likert scale with 4 items. Acceptability will be achieved if greater than or equal to 70% of children respond with scores of 1 to 5 ("It was okay, fine" and "It was good, no problem") and 70% of parents report that using the Tasso device is acceptable at or above the "Agree" range - scores of 5 or 6.
Time frame
Baseline3
Feasibility of Collecting 24-hour Urine
Feasibility will be measured as the frequency/percentage who provide at least 3 of the 4 urine samples in the 24-hour period, measured at two time points: baseline and week 8. At-home collection of dried urine samples will be considered feasible if greater than or equal to 70% of children provide the sample.
Time frame
4x on one day only to reflect 24-hour urine collection - Baseline, Week 84
Acceptability of Collecting 24-hour Urine
Child acceptability will be a 6-point Likert scale of 4 questions with a visual analog scale and brief qualitative feedback regarding the urine collection process (range: Strongly Disagree to Strongly Agree). Parent acceptability will be a 6-point Likert scale with 4 questions (range: Strongly Disagree to Strongly Agree). Acceptability will be achieved if greater than or equal to 70% of children and parents report that the at-home dried urine collection method is acceptable at or above the "Agree" range - scores of 5 or 6.
Time frame
Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Sponsor institution
Source ClinicalTrials.gov