ADHD
Conditions
Brief summary
The purpose of the study is to establish the feasibility of collecting 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.
Detailed description
The overall objective 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) among adolescent females with Attention Deficit Hyperactivity Disorder (ADHD) and explore the links between within-individual E2 variability and EMA-derived outcomes, across menstrual cycles in this population. We aim to establish sufficient pilot data to support a R01 proposal focused on characterizing relationships between E2 across the menstrual cycle, sleep, ADHD symptoms, and related symptomatology in adolescent females with ADHD. Participants will complete an initial screening visit answering questionnaires related to puberty, ADHD, and sleep to establish eligibility. After completing a device training session, we will ask participants to provide daily urine E2 samples and EMA brief assessments of ADHD and related clinical features (i.e., mood, executive functioning, sleep) over 2 menstrual cycles (\ 56 days). Sleep will be assessed continuously over the study period via convenient wearable (Garmin watch). Feasibility of protocol will be assessed as days of successful E2 data collection, EMA completion, and Garmin wear. Feasibility benchmark=80% actual/anticipated data collection. Multilevel modeling will explore the relationship between within-person changes in E2, ADHD symptoms and related clinical outcomes, and whether sleep strengthens (moderates) these relationships.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Access to internet and smartphone device with capacity to download the intervention App (iOS and Android);
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Collecting Estradiol (E2) | 56 Days | The percentage of actual E2 data collected compared to anticipated E2 data collected |
| Feasibility of Collecting Garmin Data | 56 Days | The percentage of actual Garmin data collected compared to anticipated Garmin data collected |
| Feasibility of Collecting Ecological Momentary Assessments (EMA) | 56 Days | The percentage of actual EMA data collected compared to anticipated EMA data collected |
Countries
United States
Contacts
CONTACTMatthew Gibson
PRINCIPAL_INVESTIGATORJessica Lusnford-Avery, Ph.D.
Duke University
Outcome results
None listed