Optimizing Research With Diverse Families

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood

Intervention / Treatment
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* Dietary Supplement: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility of using multinutrient intervention with previously under-represented populations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micronutrient<br>All participants will take the active micronutrient treatment; capsules of broad spectrum micronutrients. | Dietary Supplement: Broad Spectrum Micronutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants<br>* Participants will take 2-3 capsules of EMP+ two to three times per day for eight weeks.<br>* Other names: EmpowerPlus (EMP+);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |