跳至主要内容
临床试验/NCT07597707
NCT07597707招募中不适用

ADHD-Her: An Observational Research Protocol for Investigating Health, Equity, and Resilience (HER) in Girls and Women With ADHD Across the Lifespan

University of Calgary1 个研究点 分布在 1 个国家目标入组 1,460 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,460
试验地点
1

研究概览

简要总结

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.

详细描述

The ADHD-Her: Health, Equity and Resilience Study is an observational cross-sectional online study aiming to compile multiple indicators of health and well-being in girls and women with ADHD. We are aiming to enroll at least 1,460 individuals aged 10 years or older who are assigned female at birth or identify as a girl or woman, recruited from communities across Canada. All aspects of the study will be completed remotely, and will be available in both English and French. We will aim to recruit a minimum of 252 participants evenly distributed across five age strata: adolescence (10-17 years); emerging adulthood (18-25 years); early adulthood (26-39 years); middle adulthood (40-54 years); and older adulthood 55+ years). Study participants aged 10-17 years will be enrolled with a parent as a child-parent dyad, where the parent may also fulfill eligibility criteria and complete adult-specific survey measures as an adult participant in addition to participating as a member of the dyad. The sample size was chosen to allow sufficiently powered analyses between and within groupings, providing a controlled means to estimate associations contingent on age, life stage, and diagnostic status. Child participants will be over-recruited with an additional 180 child/parent dyads to account for the multiple processes that occur through this period of development and within group analyses. Some strata may be overrecruited (i.e., 'suspected') to account for inconsistencies in self-report that result in reclassification to control status to ensure all analyses remain adequately powered. Participants will be enrolled on a rolling basis until sample size requirements for each age stratum are met.

Participants will be considered for inclusion in this study if they: 1) were assigned female at birth or gender identity of girl or woman; 2) are fluent in English or French; 3) are aged 10 years or older; 4) currently reside in Canada. Self-reported intellectual disability will be exclusionary. We will enroll participants who have been diagnosed with ADHD by a healthcare practitioner ('ADHD'), who suspect they may have ADHD but have not been formally diagnosed ('Suspected'), or who have neither confirmed nor suspected ADHD ('Control'). The 'suspected' group is intended to capture potential ADHD cases that may have been missed or misdiagnosed, given evidence of high rates of misdiagnosis among girls and women (Attoe & Climie 2023; Skoglund et al., 2024). Our target enrollment will be 500 'ADHD', 500 'suspected' and 460 'control' participants.

Two protected links to study surveys (one for the parent/guardian to complete and a second for the minor child/adolescent participant to complete) will be emailed to the parent/guardian. Adult participants will acknowledge digital informed consent and assent before accessing the online survey questions. Child respondents will provide assent prior to participation in any study activities.

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.

Interested participants will contact the study team via an email address provided on the recruitment materials in order to receive a link to an online screening survey, described below. Alternatively, interested participants can access the screener survey directly through posted links or QR codes on recruitment materials. This screening survey aims to ensure they meet the inclusion criteria and to screen out any automated computer-generated responders. Eligible respondents will then receive an email link to the online study survey, described below, along with a written description of the study's design, purpose, risks and benefits, and ongoing rights to rescind consent. They will also provide consent by electronically signing an informed consent form prior to participation in any study measures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Self-reported intellectual disability

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emma Climie

Associate Professor

University of Calgary

研究点 (1)

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