Autistic Spectrum DisorderNCT05497167
Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities
A study testing Period Kit in people with Autistic Spectrum Disorder and Patient Empowerment, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Autistic Spectrum Disorder, Patient Empowerment, Menstrual Discomfort
- What is being tested?
- Period Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 29 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Overview of procedures:
- Screening phone call with parent/guardian (10-15 minutes)
- Initial study visit and pre-study survey, on Zoom with parent/guardian and minor (60 minutes)
- In-person period kit distribution at the Center for Children with Special Needs with parent/guardian and minor (5-10 minutes)
- Two-week interlude for participants to experiment with kit components
- Final study visit and post-study survey, on Zoom with parent/guardian and minor (60 minutes)
This study will involve distributing and evaluating the efficacy of "period kits" for approximately 15-25 pre-menarchal participants and parent/guardian pairs. Study participants will be selected by convenience sampling for adolescents under 18 years of age with imminent medical appointments at the Center for Children with Special Needs (CCSN) at Tufts; if more participants are needed, Dr. Crehan will assist in recruitment from other networks (e.g., through social media posts on Facebook and Instagram, and posting on the Crehan lab website at https://sites.tufts.edu/crehanlab/).
If contacted participants express interest to participate, the study team will engage with them in a screening phone call to further discuss the study, as well as verify eligibility and CCSN appointment date and time so that the initial Zoom study visit may be scheduled on a date preceding the CCSN appointment. After this phone call, participants will be sent a Visit 1 invitation email with Zoom information for this first study visit.
At the initial study visit, members of the study team will meet prospective on Zoom at the time scheduled in the screening phone call. Team members will explain the study design, reinforce that participation is optional, and obtain consent/assent from each adolescent participant and respective parent/guardian. Study team members will briefly interview the participating minor and parent/guardian and receive verbal responses. Then, study team members will administer a brief Qualtrics pre-study survey (15 minutes) for completion by each participant's parent/guardian on their own device. Finally, during the same visit, study team members will go over all contents of the period kit, ensuring to answer any questions that may arise. The study team will then confirm the time of the participant's upcoming CCSN appointment, reiterate that the participant will be given a period kit at the CCSN immediately following the appointment, and arrange a visit after a two-week trial period to discuss kit efficacy in mitigating any puberty- and menstruation-related concerns and anxieties.
Period kit components will constitute the following:
- Period management resources for practice with sensory stimuli, including:
- Appropriately sized pads, tampons, and period underwear
- Menstruation-related social story b. Includes easily interpretable graphics on how to appropriately and hygienically manage menstruation, as well as terminology with which to refer to relevant anatomy and respective functions
- Illustrated resource list, including:
- Evidence-based free period tracking apps d. Evidence-based puberty-related books e. Hormonal menstrual suppression: indication as a period management option, and suggestion to discuss, if interested, with a pediatrician f. Symptom management suggestions: e.g., over-the-counter pain medications, exercise, and heating pads
- Zippered pouch encasing all aforementioned supplies, for convenient handling and use by study participants. Participants will be able to keep all supplies after participation.
After the two-week trial period, the study team will meet with all participants again on Zoom to ask questions to the participating minor and parent/guardian and receive verbal responses. The study team will then administer the post-study survey (15 minutes) on Qualtrics to evaluate how kit components may have impacted families' anxiety levels and sense of knowledge and preparedness concerning menstruation and other imminent developmental changes. The survey will be conducted online, with results only accessible by study team members.
A thematic analysis will be performed for qualitative evaluation of all collected data; questionnaires will be margin coded to identify unique and recurrent themes using a modified grounded theory approach in an iterative process. Content analysis will be used to identify themes across study participants. Discrepancies in coding will be resolved using a constant comparison and consensus approach. All responses will be imported into a web-based software program (NVivo) to facilitate the organization and analyses of this qualitative data.
- Being tested
- Period Kit
- Keywords
- menarche, autism, intellectual and developmental disability, patient education, period resources
- Medical subject headings
- Autism Spectrum Disorder, Patient Participation, Autistic Disorder, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Period KitOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Period Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start23 Sep 2022
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autistic Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be patients with intellectual and developmental disability who have not yet had menarche.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497167
- Sponsor's protocol ID
- STUDY00002861
- Status last verified
- May 2024
- First submitted
- 22 Jul 2022
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27899267Chiri 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.
PubMed 21667201Muskat 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.
PubMed 24811967
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of "Period Kits" for Adolescents With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT05497167
- Acronym / sponsor ID
- STUDY00002861
- Keywords
- menarche, autism, intellectual and developmental disability, patient education, period resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Tufts University
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overview of procedures:
- Screening phone call with parent/guardian (10-15 minutes)
- Initial study visit and pre-study survey, on Zoom with parent/guardian and minor (60 minutes)
- In-person period kit distribution at the Center for Children with Special Needs with parent/guardian and minor (5-10 minutes)
- Two-week interlude for participants to experiment with kit components
- Final study visit and post-study survey, on Zoom with parent/guardian and minor (60 minutes)
This study will involve distributing and evaluating the efficacy of "period kits" for approximately 15-25 pre-menarchal participants and parent/guardian pairs. Study participants will be selected by convenience sampling for adolescents under 18 years of age with imminent medical appointments at the Center for Children with Special Needs (CCSN) at Tufts; if more participants are needed, Dr. Crehan will assist in recruitment from other networks (e.g., through social media posts on Facebook and Instagram, and posting on the Crehan lab website at https://sites.tufts.edu/crehanlab/).
If contacted participants express interest to participate, the study team will engage with them in a screening phone call to further discuss the study, as well as verify eligibility and CCSN appointment date and time so that the initial Zoom study visit may be scheduled on a date preceding the CCSN appointment. After this phone call, participants will be sent a Visit 1 invitation email with Zoom information for this first study visit.
At the initial study visit, members of the study team will meet prospective on Zoom at the time scheduled in the screening phone call. Team members will explain the study design, reinforce that participation is optional, and obtain consent/assent from each adolescent participant and respective parent/guardian. Study team members will briefly interview the participating minor and parent/guardian and receive verbal responses. Then, study team members will administer a brief Qualtrics pre-study survey (15 minutes) for completion by each participant's parent/guardian on their own device. Finally, during the same visit, study team members will go over all contents of the period kit, ensuring to answer any questions that may arise. The study team will then confirm the time of the participant's upcoming CCSN appointment, reiterate that the participant will be given a period kit at the CCSN immediately following the appointment, and arrange a visit after a two-week trial period to discuss kit efficacy in mitigating any puberty- and menstruation-related concerns and anxieties.
Period kit components will constitute the following:
- Period management resources for practice with sensory stimuli, including:
- Appropriately sized pads, tampons, and period underwear
- Menstruation-related social story b. Includes easily interpretable graphics on how to appropriately and hygienically manage menstruation, as well as terminology with which to refer to relevant anatomy and respective functions
- Illustrated resource list, including:
- Evidence-based free period tracking apps d. Evidence-based puberty-related books e. Hormonal menstrual suppression: indication as a period management option, and suggestion to discuss, if interested, with a pediatrician f. Symptom management suggestions: e.g., over-the-counter pain medications, exercise, and heating pads
- Zippered pouch encasing all aforementioned supplies, for convenient handling and use by study participants. Participants will be able to keep all supplies after participation.
After the two-week trial period, the study team will meet with all participants again on Zoom to ask questions to the participating minor and parent/guardian and receive verbal responses. The study team will then administer the post-study survey (15 minutes) on Qualtrics to evaluate how kit components may have impacted families' anxiety levels and sense of knowledge and preparedness concerning menstruation and other imminent developmental changes. The survey will be conducted online, with results only accessible by study team members.
A thematic analysis will be performed for qualitative evaluation of all collected data; questionnaires will be margin coded to identify unique and recurrent themes using a modified grounded theory approach in an iterative process. Content analysis will be used to identify themes across study participants. Discrepancies in coding will be resolved using a constant comparison and consensus approach. All responses will be imported into a web-based software program (NVivo) to facilitate the organization and analyses of this qualitative data.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be patients with intellectual and developmental disability who have not yet had menarche.
| Arm | Type | Receives |
|---|---|---|
| Period Kit | Experimental | Other: Period KitThis 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Period KitThis 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 |
Primary outcome
Number of participants who report feeling more comfortable and/or prepared for menstruation after period kit exploration
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 27899267Vogan 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.
- Background: PubMed 21667201Chiri 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.
- Background: PubMed 24811967Muskat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Period Kit in people with Autistic Spectrum Disorder and Patient Empowerment, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who report feeling more comfortable and/or prepared for menstruation after period kit exploration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497167, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.