Clinical trial
Understanding Mental Health Crises in Youth With Intellectual and Developmental Disabilities
Name
801938
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. The 150 youth will be compared to historical, publicly available cohorts of youth with IDD's
Trial arms
Trial start
2023-03-29
Estimated PCD
2026-07-01
Trial end
2027-07-01
Status
Recruiting
Treatment
Genomic sequencing and molecular diagnostic results, if any.
Genomic sequencing results may be used for diagnosis and treatment of participants.
Arms:
Enrollees
Other names:
Pediatric Precision Medicine
EHR-Based Network Model
EHR-based network will be created to predict psychiatric outcomes in youth with IDDs
Arms:
Enrollees
Size
150
Primary endpoint
Extract from Rady EHR demographic, biomedical, socioeconomic, and service use data for 150 youth with IDDs presenting to the ED for MHCs
4 years
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Using whole genome sequencing, with biospecimens stored at RCIGM laboratory, evaluate the rate of pathogenic rare variants detected between cohorts.'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-04-18
1 organization
1 product
1 indication
Indication
Intellectual disability