CompletedNot Applicable

Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities

United States50 participantsStarted 2022-09-23

Plain-language summary

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.

Who can participate

Age range5 Years – 17 Years

SexFEMALE

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. Those that do not meet any of the aforementioned criteria
✕. Minors who are:
✕. Wards of the state and/or children at risk of becoming wards of the state
✕. Non-English speakers

What they're measuring

Number of participants who report feeling more comfortable and/or prepared for menstruation after period kit exploration

Timeframe: 12 months

Trial details

NCT IDNCT05497167

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-29

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