Feasibility and Acceptability Study of a Powdered Multinutrient Formula in Children With Attention-Deficit/Hyperactivity Disorder and Emotional Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility measured by count of remaining Sticks
研究概览
简要总结
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires.
详细描述
The study aims to test the feasibility and acceptability of 1) consumption of EMPowerplus Lightning Sticks, 2) at-home collection of blood and urine samples, and 3) remote visits and completion of online behavioral questionnaires. A limited number of blood samples will be used to generate cytokine data to test the ability to detect these molecules from the Tasso device-collected plasma. Parent and child questionnaire responses will examined for signals of change, but no formal statistical comparisons will be performed. This study will inform us whether a larger efficacy study is possible in this population.
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
- 7 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age inclusive of and between 7 and 16 years at the time of enrollment
- •Verbally willing to ingest one EmpowerPlus Lightning Stick daily
- •Attend all virtual study appointments and complete questionnaires
- •Have been previously enrolled in a multinutrient study OR complete a screening to match with participants from that study in terms of age and symptoms of ADHD and emotional dysregulation
- •Be medication and supplementation free (if supplement ingredient is contained in the Lightning Stick) prior to study initiation
- •Willing to collect blood and urine samples, once, at home.
排除标准
- •Neurological disorder involving brain or other central function (e.g., history of, or suspected, intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder, active suicidal ideation, or psychosis), based on parent/guardian self-report of child's condition
- •Any serious medical condition, including inflammatory bowel disease, history of cancer, kidney or liver disease, hyperthyroidism, diabetes Type I or II
- •Known allergy to any ingredients of the intervention
- •Any known abnormality of mineral metabolism (e.g., Wilson's disease, hemochromatosis)
- •Taking any medication with primarily central nervous system activity, including stimulants used to treat symptoms of ADHD
- •Any disability that would interfere with participant answering questions verbally
- •Non-English speaking
- •Pregnancy or sexually active at baseline. *Exclusion criteria will be based on parent/guardian report on child. If the parent/guardian reports medical exclusion criteria, or concerns about eligibility, data provided by parent/guardian will be confirmed by review of medical records with release of information signed by parent/guardian. Potential participants may be reviewed virtually by study physician in the case of any concerns about participation.
研究组 & 干预措施
Lightning Stick
Feasibility and acceptability
干预措施: EmpowerPlus Lightning Sticks (Dietary Supplement)
结局指标
主要结局
Feasibility measured by count of remaining Sticks
时间窗: week 6
Feasibility will be determined if consumption of one Lightning Stick daily is achieved when greater than or equal to 80% of provided Sticks were taken. Measured by count of remaining (unused) Sticks.
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
时间窗: week 6
Acceptability of taking the Lightning Sticks will be measure 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 powdered multinutrients is acceptable, at or above the Agree range.
次要结局
- Feasibility of remote study visits measured by count of participants who complete all online remote study visits(week 6)
- Feasibility measured by count of participants who provide the dried urine sample(once, at baseline)
- Feasibility measured by count of participants who provide blood using the Tasso device(once, at baseline)
- Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw(once, at baseline)
- Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits(week 6)
- Monitor participants for side effects by count of 'yes' if listed symptoms are new or have increased in severity, using the question format from the Pediatric Adverse Events Rating Scale(week 6)
- Acceptability measured by a 'yes' response to their preference of using the at-home dried urine sample collection method instead of a lab-based urine sample collection method(once, at baseline)
研究者
Jeanette Johnstone
Associate Professor
Oregon Health and Science University