NCT07597707

Brief Summary

The goal of this observational study is to generate a comprehensive, multi-dimensional dataset of health indicators collected from girls and women (aged 10 years and older) with and without ADHD across the lifespan. Participants will be asked to complete a detailed survey about hormonal and developmental life phases, ADHD status and symptoms, childhood experiences, health and well-being, and psychosocial outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,460

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2025Dec 2026

Study Start

First participant enrolled

August 25, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 7, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

ADHDwomenwomangirlgirlsfemalefemaleshormonehormoneshormonal

Outcome Measures

Primary Outcomes (2)

  • Self-reported mental health

    Self-reported mental health history (assessed using a study-developed questionnaire querying current depression, anxiety, OCD, bipolar disorder, personality disorders, conduct disorder, oppositional defiant disorder, learning disorders, and other mental health challenges, as well as medication use for these conditions). This is a check list of disorders in which participants can self-identify diagnoses. There is no minimum/maximum.

    baseline (upon entry into study)

  • Depression, anxiety, and stress

    Depression, anxiety, and stress measured using the 18-item Depression Anxiety Stress Scales. Participants are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Higher scores are indicative of greater distress.

    baseline (upon entry into study)

Study Arms (3)

Diagnosed ADHD

Participants who self-report that they have been diagnosed with ADHD by a healthcare practitioner.

Other: No Intervention: Observational Cohort

Suspected ADHD

Participants who self-report that they suspect they have ADHD but have not received a formal diagnosis.

Other: No Intervention: Observational Cohort

Controls

Participants who neither have a self-reported diagnosis of ADHD, nor suspect they have ADHD.

Other: No Intervention: Observational Cohort

Interventions

This is an observational study with no intervention. Participants will only complete self-report questionnaires.

ControlsDiagnosed ADHDSuspected ADHD

Eligibility Criteria

Age10 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruitment will occur via multiple methods. Advertisements will be posted in communities across Canada (e.g., in medical clinics, ADHD clinics, community centres, etc.) via flyers and posters. In addition, recruitment materials will be posted online through social media posts (e.g., Instagram, Facebook, and LinkedIn), and University websites (e.g., The University of Calgary's 'Participate in Research' website). Potential participants will also be free to share recruitment information through their personal social media/email platforms or forward recruitment information to others, and study collaborators will disseminate recruitment information through their available channels and through community partner organizations. Lastly, eligible participants who have previously enrolled in our research studies and have consented to be contacted for future studies will be invited to participate.

You may qualify if:

  • Assigned female at birth or identify as girl or women
  • Fluency in English or French
  • Aged 10 years or older
  • Currently reside in Canada
  • Access to technology to complete study measures

You may not qualify if:

  • Self-reported intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Emma A Climie, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma A Climie, PhD

CONTACT

Brandy L Callahan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 19, 2026

Study Start

August 25, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) may be shared with other researchers after data collection is complete and after publication of study results. Data sharing will only take place with permission of the principal investigator and in accordance with participant consent, applicable privacy regulations, and institutional data management policies. Data will be shared in coded form for scientific research purposes only and may require a data sharing agreement. Requests for access to the data can be submitted to the principal investigator.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Individual participant data and supporting materials will become available after data collection is complete. Data will be available upon reasonable request for scientific research purposes, subject to approval by the principal investigator and in accordance with participant consent and applicable privacy regulations. Data will remain available indefinitely after completion of the study.
Access Criteria
Researchers may request access to de-identified individual participant data (IPD) and related materials for scientific purposes. Accessible materials include the de-identified dataset, along with the study protocol and analytic code. Access requests should be directed to the principal investigator, who will review and approve them in line with participant consent, applicable privacy regulations, and institutional data governance policies. Approved data sharing may be facilitated through a formal data sharing agreement.

Locations