An interventional study of EmpowerPlus Lightning Sticks in Attention Deficit Hyperactivity Disorder, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 7 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria*:
Feasibility and acceptability
Dietary Supplement: EmpowerPlus Lightning Sticks
multinutrient supplement containing vitamins, minerals, amino acids and antioxidants taken one Stick daily by dissolving the powder on or under the tongue
Feasibility measured by count of remaining Sticks
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.
Time frame: week 6
Abbreviated Acceptability Rating Profile - 7 questions on a 6-point Likert scale
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.
Time frame: week 6
Feasibility measured by count of participants who provide blood using the Tasso device
At-home collection of blood with the Tasso device will be considered feasible if greater than or equal to 70% of children provide the sample.
Time frame: once, at baseline
Acceptability measured by a 'yes' response to their preference of using the Tasso device instead of a lab-based blood draw
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the Tasso at-home collection method instead of going to a lab to provide the blood sample.
Time frame: once, at baseline
Feasibility measured by count of participants who provide the dried urine sample
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: once, at baseline
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
Acceptability will be measured if greater than or equal to 70% of children and parents state they preferred the at-home dried urine collection method instead of going to a lab to provide the urine sample.
Time frame: once, at baseline
Feasibility of remote study visits measured by count of participants who complete all online remote study visits
Feasibility will be determined if greater than or equal to 70% of parents/guardians complete all three remote visits
Time frame: week 6
Acceptability measured by a 'yes' response to their preference of completing online remote study visits instead of in-person study visits
Acceptability will be measured if greater than or equal to 70% of parents state they preferred completing online remote study visits instead of in-person study visits
Time frame: 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
Parent and child report of side effects, including: headache, dry mouth, sleep disruptions, nausea, irritability, fatigue, anxiety, changes in appetite, skin rash, migraines, and other (specify what symptom).
Time frame: week 6
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University