NCT05497167Completed
Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities
Source: ClinicalTrials.gov · Last updated 31 May 2024
Brief summary (registry, in English)
This study will involve the development, distribution, and evaluation of "period kits" for pre-menarchal adolescents with intellectual and cognitive disabilities (IDD) (e.g., autism spectrum disorder and Down syndrome) in relieving stress and augmenting sense of preparedness regarding imminent pubertal changes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 22 Jul 2022
- Start date
- 23 Sept 2022
- Primary completion date
- 29 May 2024
- Lead sponsor
- Tufts Medical Center
- Diseases
- Autism
- NCT number
- NCT05497167
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 23 Sept 2022 to the primary completion date, 29 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Those that do not meet any of the aforementioned criteria
- Minors who are:
- married, widowed, divorced; or ii) the parent of a child; or iii) a member of any of the armed forces; or iv) pregnant or believes herself to be pregnant; or v) living separate and apart from his/her parent or legal guardian, and is managing his/her own financial affairs
- Wards of the state and/or children at risk of becoming wards of the state
- Non-English speakers
Who the study is looking for
- Minors from 5 to 17 years of age
- Those with the capacity to eventually menstruate but who have not yet had a menstrual period
- Those with an Intellectual and Developmental Disability (IDD), defined here using DSM diagnostic labels: autism spectrum disorder, Global Developmental Delay, Unspecified Neurodevelopmental Disorder (which includes Down Syndrome and fragile-X)
Age in the registry: 5 years to 17 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.