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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06169709
Other study ID # Survey Female ADHD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 20, 2024
Est. completion date September 2024

Study information

Verified date March 2024
Source Parnassia Groep
Contact Daniëlle de Graaf-Starreveld, PhD
Phone +31 88 35 711 93
Email d.degraaf-starreveld@parnassiagroep.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this exploratory study following a cross-sectional online survey in women with ADHD is to 1. describe overall experiences regarding ADHD symptoms, diagnosis, treatment, sources of support, and any perceived barriers on those domains; 2. determine which life domains are most affected by ADHD symptoms; 3. calculate the prevalence of reported health conditions within the following domains: circulatory system, endocrine or metabolic system, gastrointestinal system, genitourinary system, musculoskeletal system, nervous system, respiratory system, skin, reproductive system, cancer, psychiatric conditions, COVID-19, sensory sensitivity, menstrual cycle, and sleep; 4. identify topics that women with ADHD would like to see studied in future research.


Description:

Rationale: In clinical practice, the investigators see that ADHD affects women differently than men. It has become clear that a better understanding of ADHD in girls and women is needed to improve their longer-term wellbeing and functional and clinical outcomes. Objective: The primary endpoint is to describe the overall experience of women with ADHD regarding ADHD symptoms, diagnosis, treatment, and any perceived barriers relating to these domains. The investigators also want to determine the effects of ADHD symptoms on day-to-day life across various life domains. Moreover, the investigators want to determine the prevalence of reported health conditions. Study design: This is an exploratory study following a cross-sectional online survey. Study population: Women (aged >18 years) with ADHD. Intervention (if applicable): Not applicable. Main study parameters/endpoints: In women with ADHD, the investigators want to 1) describe overall experiences regarding ADHD symptoms, diagnosis, treatment, sources of support, and any perceived barriers on those domains; 2) determine which life domains are most affected by ADHD symptoms; 3) calculate the prevalence of reported health conditions within the following domains: circulatory system, endocrine or metabolic system, gastrointestinal system, genitourinary system, musculoskeletal system, nervous system, respiratory system, skin, reproductive system, cancer, psychiatric conditions, COVID-19, sensory sensitivity, menstrual cycle, and sleep; 4) identify topics that women with ADHD would like to see studied in future research. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This survey is the first to study experiences and health of women with ADHD internationally, and results will provide insights and leads for all involved with diagnosis and treatment of these women. Risks of participation are considered low. Participants might consider certain questions triggering, but are always free to skip questions and stop the survey.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Identify as a woman - Aged 18 or above - Have ADHD (both diagnosed by a health professional and self-diagnosed) Exclusion Criteria: - People who are not able to read, understand, or sign the information letter or informed consent form are excluded from participation.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Parnassia Groep Den Haag

Sponsors (1)

Lead Sponsor Collaborator
Parnassia Groep

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary To describe the overall experiences, thoughts, and perspectives of women with ADHD, including domains of ADHD diagnosis and symptoms, ADHD and other health conditions, menstrual cycle, conflict tactics and romantic relationships, and sleep. A self-developed questionnaire. The sections on demographic information, ADHD diagnosis, ADHD diagnosis & symptoms and menstrual cycles are constructed for the purpose of this survey. Moreover, the questionnaire contains sections from the Ultrashort screener for adult ADHD, the Holland Sleep Disorder Questionnaire and the Conflict Tactics scale 2. 50 minutes
Secondary To identify topics for further research and ways of improving healthcare (e.g. the diagnostic process or effective treatment) for women with ADHD Questions are included in the questionnaire described for outcome 1. 50 minutes
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