Dynamic Relationships Between Estrogen Fluctuations, Sleep, and Psychiatric Complexity Among Adolescent Females With ADHD

ConditionADHD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age11-15
SponsorDuke University

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Adolescent Females with Attention Deficit Hyperactivity Disorder (ADHD)

Trial outcomes

Primary outcomes

1

Feasibility of Collecting Estradiol (E2)

The percentage of actual E2 data collected compared to anticipated E2 data collected

Time frame
56 Days
2

Feasibility of Collecting Garmin Data

The percentage of actual Garmin data collected compared to anticipated Garmin data collected

Time frame
56 Days
3

Feasibility of Collecting Ecological Momentary Assessments (EMA)

The percentage of actual EMA data collected compared to anticipated EMA data collected

Time frame
56 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: