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NCT05497167 · ClinicalTrials.gov registry record · NA
Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities
A NA study of Patient Empowerment and Autistic Spectrum Disorder, sponsored by Tufts Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05497167: Completed NA study of Patient Empowerment and Autistic Spectrum Disorder, sponsored by Tufts Medical Center.
NCT05497167 is a NA study of Patient Empowerment and Autistic Spectrum Disorder that has completed, run by Tufts Medical Center. The registered enrollment target is 50 participants, below the 229-participant average among 4 other Patient Empowerment trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05497167, a NA study of Patient Empowerment and Autistic Spectrum Disorder, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The aim of the study is to develop, optimize, and evaluate the efficacy of a "period kit" for adolescents with cognitive disability and their families. The purpose of the kit is to familiarize and educate this population about menstruation and other puberty-related changes, ideally prior to the first menstrual period. Response to this kits will inform future work on whether these materials are helpful for medical care teams to provide education and resources for patients with intellectual and de
Conditions Studied
Interventions
- OTHER Period Kit
Study Locations (1)
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-09-23 |
| Est. Completion | 2024-05-29 |
| Phase | NA |
What the finished NCT05497167 record still lists
NCT05497167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 229-participant average among 4 other Patient Empowerment trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Patient Empowerment appearing as the primary indexed condition, and to 1 intervention - of which Period Kit is the first listed.
NCT05497167 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05497167 about?
NCT05497167 is a clinical study titled "Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities". 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 puber...
What is the current status of trial NCT05497167?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2022-09-23. Estimated completion is 2024-05-29.
What conditions does trial NCT05497167 study?
This clinical trial studies the following conditions: Patient Empowerment, Autistic Spectrum Disorder, Menstrual Discomfort.
What interventions are being tested in trial NCT05497167?
The interventions under investigation include: Period Kit (OTHER).
Who is sponsoring clinical trial NCT05497167?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05497167 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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