Care in Multiple Sclerosis (MS)
CARE in MS: Childhood Adversity Research Effort in MS
2 other identifiers
observational
300
1 country
6
Brief Summary
This study is structured around three main aims. In Aim 1, investigators will conduct community-based participatory research (CBPR) to develop culturally tailored methods to assess childhood adversity in multiple sclerosis (MS). Aim 2 will investigate the impact of childhood adversity on MS outcomes among individuals with relapsing-remitting MS (RRMS), among whom 70% belong to a group historically under-represented in MS research: Black, Hispanic, or poverty-impacted. Aim 2 procedures involve two visits that include a research blood draw and an MRI scan. In Aim 3, investigators will conduct interviews and surveys to explore environmental and social factors affecting quality of life for minority MS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2025
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedStudy Start
First participant enrolled
October 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
May 5, 2026
April 1, 2026
3.7 years
June 2, 2025
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Severity of MS
Severity of MS will be measured by MRI FLAIR lesion volume among Aim 2 participants.
Baseline
Secondary Outcomes (1)
Age of MS Onset
Baseline
Study Arms (3)
Aim 1: Adults with RRMS - Focus Groups
Aim 1 will involve 2-3 focus groups, each with 8-12 participants per group. The focus group sessions will occur only one time and will take around 90-120 minutes. Aim 1 will enroll individuals with RRMS who self-identify as a Black, Hispanic, or poverty-impacted.
Aim 2: Young Adults with MS - MRI Scan
Participants enrolled in Aim 2 will complete a baseline visit and research MRI occurring around and in concurrence with their routine/standard of care visit. The study visit is estimated to take around 1 to 1.5 hours. The MRI scan is estimated to take 30 minutes. The research team will maintain contact with study participants at least annually (up to 4 years). Aim 2 will enroll 330 young adults, of whom 165 have pediatric-onset RRMS and 165 have adult-onset RRMS. Further, 70% of participants in Aim 2 must self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted.
Aim 3: Young Adults with MS - Interviews
Aim 3 will involve one-time interviews estimated to take 30 to 45 minutes to complete. Aim 3 will enroll 20 participants who have completed at least 80% of study data in Aim 2; further, 70% of participants enrolled Aim 3 participants must self-identify as Black, Hispanic, or meet criteria for poverty impacted.
Eligibility Criteria
* Aim 1: 2-3 focus groups, each with 8-12 participants per group., aged ≥18 years with RRMS, who self-identify as a Black, Hispanic, or poverty-impacted, and are fluent in English or Spanish. * Aim 2: 330 young adults (ages 18-29 years of age with MS duration of 8 years or less) of whom 165 have pediatric-onset RRMS (aged 18-25) and 165 have adult-onset (aged 19-29) RRMS. 70% self-identify as persons with MS who are either Black, Hispanic, or poverty-impacted. * Aim 3: 20 participants who have completed at least 80% of study data in the cross-sectional study/Aim 2. 70% must self-identify as Black, Hispanic, or meet criteria for poverty impacted.
You may qualify if:
- Aim 1 -
- aged ≥18-29 years
- diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
- % self-identifying as a Black, Hispanic, or poverty-impacted (up to 138% of the federal poverty level) individual,and
- fluent in English or Spanish.
- Aim 2 -
- aged ≥18-29 years
- diagnosis of RRMS (Fulfill international criteria for relapsing remitting (RRMS))
- % self-identifying as a Black, Hispanic, or poverty impacted, and
- fluent reading in English or Spanish
- Pediatric onset MS (MS onset before age 18 and age at time of enrollment is 18-25) OR adult-onset MS (MS onset at age 18 or older and age at time of enrollment is 19-29)
- Disease duration below 8 years
- Aim 3 -
- Aim 3 will enroll the first 20 participants from Aim 2 who meet the following criteria:
- completed at least 80% of study data in the cross-sectional study/Aim 2.
- +2 more criteria
You may not qualify if:
- Primary or Secondary Progressive MS
- Inability to consent.
- MS relapse within 30 days prior to study entry
- Other major neurologic or psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California, San Francisco
San Francisco, California, 94158, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Krupp, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2025
First Posted
June 10, 2025
Study Start
October 23, 2025
Primary Completion (Estimated)
June 30, 2029
Study Completion (Estimated)
June 30, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to kimberly.oneill@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: kimberly.oneill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.