Mental Health Crises in Youth With IDDs (NCT05471232) | Clinical Trial Compass
RecruitingNot Applicable
Mental Health Crises in Youth With IDDs
United States150 participantsStarted 2023-03-29
Plain-language summary
This study is an unmatched, case-control study of 150 youth (Ages 7-17) with a parent reported Intellectual Developmental Disability (IDD) who present to Rady Children's Hospital Emergency Department with a Mental Health Crisis (MHC). Rady Children's Institute for Genomic Medicine (RCIGM) will collect biological samples (such as blood) of these participants to study their genomes, medical and psychiatric profiles to better understand specific characteristics that may predispose them to MHC's. The 150 youth will be compared to historical, publicly available cohorts of youth with IDD's
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Child/adolescents admitted to the RCHSD ED with an IDD presenting in a MHC that includes, but is not limited to:
* Aggression towards others
* Severe agitation
* Self-injury
* Elopement
OR
Biological parents of child/adolescent enrolled in this study for the purposes of reflex testing. (Family members are eligible for participation in this study if they presumed genetically related to a participant).
Exclusion Criteria:
Child/Adolescents participants who do not meet any of the inclusion criteria, or those who:
* Already received any prior whole genome sequencing or exome sequencing
* Unable to approach the family or patient for enrollment
* Unable to obtain informed consent
* family members are ineligible for participation in this study if they are known to not be genetically related to the child/adolescent participant and/or if they are a member of a protected research population.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extract from Rady EHR demographic, biomedical, socioeconomic, and service use data for 150 youth with IDDs presenting to the ED for MHCs
Timeframe: 4 years
Trial details
NCT IDNCT05471232
SponsorRady Pediatric Genomics & Systems Medicine Institute