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

NCT05497167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-31

No results posted yet for this study

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.

Conditions

  • Autistic Spectrum Disorder
  • Patient Empowerment
  • Menstrual Discomfort

Interventions

OTHER

Period Kit

This is a single arm interventional study wherein the subjects enrolled will all participate in the study in the same way by being asked to answer pre-study survey questions concerning their attitudes towards menarche, receiving a period kit to explore on their own for two weeks, and then being asked to answer post-study survey questions.

Sponsors & Collaborators

  • Tufts University

    collaborator OTHER

  • Tufts Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2024-05-29
Completion
2024-05-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05497167 on ClinicalTrials.gov