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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility measured by count of consumed multinutrients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%)
排除标准
- •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
研究组 & 干预措施
Multinutrient
All participants will take the active multinutrient treatment
干预措施: Multinutrients; a 36-ingredient blend of vitamins, minerals, amino acids, and antioxidants (Dietary Supplement)
结局指标
主要结局
Feasibility measured by count of consumed multinutrients
时间窗: Week 4, Week 8
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.
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
时间窗: Week 8
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.
次要结局
- Feasibility of Capillary Blood Collection(Baseline)
- Acceptability of Capillary Blood Collection(Baseline)
- Feasibility of Collecting 24-hour Urine(4x on one day only to reflect 24-hour urine collection - Baseline, Week 8)
- Acceptability of Collecting 24-hour Urine(Week 8)
- Child and Adolescent Symptom Inventory (CASI-5)(Baseline, Week 4, Week 8)
- Clinical Global Impression - Improvement (CGI-I)(Week 4, Week 8)
- Clinical Global Impression - Severity (CGI-S)(Baseline, Week 8)
- Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24)(Baseline and Week 8)
- Parent Target Problem (PTP) using Ecological Momentary Assessment (EMA)(Baseline to Week 8, daily)
- Feasibility of Collecting Real-Time EMA Parent Target Problem (PTP)(Week 4, Week 8)
- Acceptability of Collecting Real-Time EMA Parent Target Problem (PTP)(Week 8)
- Pediatric Adverse Events Rating Scale (PAERS)(Baseline, Week 4, Week 8)
- Reasons for Dropout(Before week 7)
研究者
Jeanette Johnstone
Associate Professor
National Center for Complementary and Integrative Health (NCCIH)