About this trial
The purpose of the study is to establish the feasibility of collecting estradiol (E2), Garmin-measured sleep, and ecological momentary assessments (EMA) of ADHD and related symptoms (mood, anxiety, executive functioning) across menstrual cycles among 20 peripubertal female adolescents aged 11-15 with ADHD, and to explore links between within-individual E2 variability, sleep, and EMA-derived outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female;
Ages 11-15;
Within 2 years of first menstrual cycle (menarche);
Parent-reported ADHD diagnosis and T score ≥65 on Inattention and/or Hyperactivity/Impulsivity via Conners
Disqualifiers
Reported psychotic or bipolar disorder, sleep apnea, or restless leg syndrome;
Current suicidality/self-harm;
Plans to initiate/change psychotropic or sleep medications during participation
Trial population
Female adolescents ages 11-15 with ADHD in the Duke University Health System
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Feasibility of Collecting Estradiol (E2)
The percentage of actual E2 data collected compared to anticipated E2 data collected
Feasibility of Collecting Garmin Data
The percentage of actual Garmin data collected compared to anticipated Garmin data collected
Feasibility of Collecting Ecological Momentary Assessments (EMA)
The percentage of actual EMA data collected compared to anticipated EMA data collected
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: