Optimizing Research With Diverse Families

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

A Feasibility and Acceptability Study to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06133231
• Other study ID #: 00024336
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: Jeanette Johnstone, PhD
• Phone: 503-494-3700
• Email: jojeanet[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of micronutrients 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.

Description:

This study will test the feasibility of recruiting and completing a micronutrient 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children, ages 6-12 years at enrollment, with suspected or definite ADHD based on parent report in a family that identifies as Black or Hispanic
• Meet criteria on CASI-5 ADHD scale (6+ symptoms = 2), occurring in >1 setting, plus one impairing irritability symptom (=2) from ODD or DMDD subscale
• Able and willing to swallow 9-12 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 females: sexually active, pregnancy or suspected pregnancy
• Abnormality of mineral metabolism

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants
Participants will take 2-3 capsules of EMP+ two to three times per day for eight weeks.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measured by count of consumed micronutrients	Feasibility will be determined based on consumption of 2-3 capsules, three times a day (or less if a smaller dose is determined by study staff to be appropriate) and achieved when greater than or equal to 75% of dose is consumed at week 4 and at week 8.	Week 4, Week 8
Primary	Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale	Acceptability of taking the micronutrients 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 micronutrients is acceptable, at or above the "Agree" range - scores of 5 or 6.	Week 8
Secondary	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.	Baseline, Week 8
Secondary	Acceptability of Capillary Blood Collection	Acceptability will be a 6-point Likert scale (range: Strongly Disagree to Strongly Agree), and brief qualitative feedback regarding the blood collection process. Acceptability will be achieved if greater than or equal to 70% of children and parents report that using the Tasso device is acceptable at or above the "Agree" range - scores of 5 or 6.	Baseline, Week 8
Secondary	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.	4x on one day only to reflect 24-hour urine collection - Baseline, Week 8
Secondary	Acceptability of Collecting 24-hour Urine	Acceptability will be a 6-point Likert scale and brief qualitative feedback regarding the urine collection process (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.	Week 8
Secondary	Child and Adolescent Symptom Inventory (CASI-5)	The CASI-5 is based on the DSM-5 symptom criteria. The subscales of ADHD, Oppositional Defiant Disorder (ODD), Disruptive Mood Dysregulation Disorder (DMDD) and peer conflict will be combined into a total composite score; range is 0-3 (never, sometimes, often, very often). Higher scores represent a worse outcome. These scores will be used to look for signals of change over time.	Baseline, Week 4, Week 8
Secondary	Clinical Global Impression - Improvement (CGI-I)	The clinician-rated CGI-Improvement (CGI-I) is a subscale of the CGI that rates overall improvement of symptoms based on all relevant data. Item range is 1-7 (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse); lower score is better. A treatment responder is defined as a participant who is rated a 1 or 2 on the CGI-I. These scores will be used to look for signals of change over time.	Week 4, Week 8
Secondary	Clinical Global Impression - Severity (CGI-S)	The CGI-Severity (CGI-S) subscale will be scored at baseline and week 8, with scores compared at the two time points. Item range is 1-7 (normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients); lower score is better; most participants will be a 4 or 5 at baseline. These scores will be used to look for signals of change over time.	Baseline
Secondary	Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)	Parent report of child's 24-hour dietary intake The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool. ASA-24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records. Parent will report of child's 24-hour dietary intake at baseline and at week 8. These scores will be used to look control for dietary differences at baseline and to control for dietary changes over time.	Baseline and Week 8
Secondary	Parent Target Problem (PTP) using Ecological Momentary Assessment (EMA)	Parents are prompted to nominate the child's most impairing behavior and qualitatively describe it, then quantitatively report: 1) frequency: how often the problem behavior occurs (times a day, week), 2) duration: how long the problem behavior lasts when it occurs, 3) intensity: how impairing is it on a scale of 1 to 10. Reporting on the behavior will occur every other day, at home, in response to a pre-populated questionnaire designed to be completed in one-two minutes or less, which may be accessed on a mobile phone, tablet or computer. Data will be used to detect signals of change over time.	Baseline to Week 8 on alternate days
Secondary	Feasibility of Collecting Real-Time EMA Parent Target Problem (PTP)	Feasibility will explore the average number of timepoints the parent/caregiver provided EMA data during the prior weeks before their week 4 and week 8 visit. At-home completion of parent-target-problems will be considered feasible if parents respond to greater than or equal to 70% of the prompts.	Week 4, Week 8
Secondary	Acceptability of Collecting Real-Time EMA Parent Target Problem (PTP)	Acceptability will be a 6-point Likert scale and brief qualitative feedback regarding the EMA data collection process (range: Strongly Disagree to Strongly Agree). Acceptability will be achieved if greater than or equal to 70% of parents report that the EMA data collection method is acceptable at or above the "Agree" range, scores of 5 or 6.	Week 8
Secondary	Pediatric Adverse Events Rating Scale (PAERS)	Parent will report on possible side effects using PAERS to respond to presence, frequency and severity of 43-items, including: headache, dry mouth, sleep disruptions, nausea, irritability, fatigue, anxiety, changes in appetite, skin rash, migraines, and other (parents specify the symptom). Occurrence of these data will be reported at week 4 and 8.	Baseline, Week 4, Week 8
Secondary	Reasons for Dropout	In order to assess for acceptability, parents whose children drop out of the study before week 7 will be contacted to ask, qualitatively, their reason for dropout. The responses will be recorded and reported .+	Before week 7