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

NCT05497167 | Completed

• 1 other identifier: STUDY00002861
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

menarche; autism; intellectual and developmental disability; patient education; period resources

Outcome Measures

Primary Outcomes (1)

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

  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 developmental disabilities. The study outcome will be measured by the number of subjects who report feeling more comfortable and/or prepared for menstruation after period kit exploration, based on questionnaire responses.

  12 months

Study Arms (1)

Period Kit

EXPERIMENTAL

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.

Other: Period Kit

Interventions

Period Kit OTHER

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.

Period Kit

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Those that do not meet any of the aforementioned criteria
• Minors who are:
• i) 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Tufts University: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

• Vogan V, Lake JK, Tint A, Weiss JA, Lunsky Y. Tracking health care service use and the experiences of adults with autism spectrum disorder without intellectual disability: A longitudinal study of service rates, barriers and satisfaction. Disabil Health J. 2017 Apr;10(2):264-270. doi: 10.1016/j.dhjo.2016.11.002. Epub 2016 Nov 22.

  PMID: 27899267 BACKGROUND

• Chiri G, Warfield ME. Unmet need and problems accessing core health care services for children with autism spectrum disorder. Matern Child Health J. 2012 Jul;16(5):1081-91. doi: 10.1007/s10995-011-0833-6.

  PMID: 21667201 BACKGROUND

• Muskat B, Burnham Riosa P, Nicholas DB, Roberts W, Stoddart KP, Zwaigenbaum L. Autism comes to the hospital: the experiences of patients with autism spectrum disorder, their parents and health-care providers at two Canadian paediatric hospitals. Autism. 2015 May;19(4):482-90. doi: 10.1177/1362361314531341. Epub 2014 May 8.

  PMID: 24811967 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Patient Participation; Autistic Disorder; Developmental Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be patients with intellectual and developmental disability who have not yet had menarche.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 11, 2022
• Study Start: September 23, 2022
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)