Mental Health Crises in Youth With IDDs
ConditionIntellectual Disability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorRady Pediatric Genomics & Systems Medicine Institute
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aggression towards others
Severe agitation
Self-injury
Elopement
Disqualifiers
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.
Trial population
Children/adolescents admitted to the RCHSD ED with an IDD presenting in a MHC
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Genomic sequencing and molecular diagnostic results, if any.
GeneticGenomic sequencing results may be used for diagnosis and treatment of participants.
EHR-Based Network Model
Other interventionEHR-based network will be created to predict psychiatric outcomes in youth with IDDs
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Enrollees2 interventions
Group B: Historical Control Group0 interventions
Trial outcomes
Primary outcomes
1
Extract from Rady EHR demographic, biomedical, socioeconomic, and service use data for 150 youth with IDDs presenting to the ED for MHCs
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.
Time frame
4 yearsSecondary outcomes
1
Adjusted Relative Risk of Neuropsychiatric Polygenic Scores
The adjusted relative risk of neuropsychiatric polygenic scores in youth with intellectual and developmental disabilities and mental health crises compared to youth with intellectual and developmental disabilities without mental health crises. A relative risk of 1 represents equal risk between groups. A relative risk \<1 represents a lower risk in the mental health crisis group and a relative risk of \>1 represents a higher risk in the mental health crisis group.
Time frame
4 yearsOther outcomes
1
Diagnostic Rate
A diagnostic rate of whole genome sequencing will be compared between our primary cohort and two comparator cohorts
Time frame
4 yearsSponsors and contacts
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Source ClinicalTrials.gov