NCT05471232 · Rady Pediatric Genomics & Systems Medicine Institute
Mental Health Crises in Youth With IDDs
What this study is about
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).
View original scientific description
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.
Interventions
GENETIC
Genomic sequencing and molecular diagnostic results, if any.
Genomic sequencing results may be used for diagnosis and treatment of participants.
OTHER
EHR-Based Network Model
EHR-based network will be created to predict psychiatric outcomes in youth with IDDs
Primary outcome measures
Extract from Rady EHR demographic, biomedical, socioeconomic, and service use data for 150 youth with IDDs presenting to the ED for MHCs
Time frame: 4 years
Area under the receiver operating characteristic curve for a network model that predicts psychiatric outcomes for youth with intellectual and developmental disabilities. Area under the receiver operating characteristic curve has a minimum value of 0.5 and a maximum value of 1, where higher scores represent more accurate predictions of psychiatric outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 9, 2024 · Source of record for eligibility and locations