Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

Approximately 7 million youth in the US have intellectual and developmental disabilities (IDDs) and about 10% of youth with IDDs are admitted to hospitals due to a mental health crisis (MHC) each year. With insufficient community services to support youth with IDDs and less than half of US mental health facilities providing services for them, emergency departments (EDs) have boarding rates for children with IDDs 2-3 times higher than peers without IDDs, part of a national youth mental health crisis. There is a critical need to identify youth with IDDs at risk for MHCs prior to onset. Machine-learning based electronic health record (EHR) analysis and whole genome sequencing (WGS) will be used to identify biopsychosocial and genomic risk factors that put youth with IDDs at risk for MHCs so that at-risk patients can be identified early and improved models of psychiatric care can be developed. Demographic, biomedical, socioeconomic, and service use data will be extracted from Rady Children's Hospital San Diego (RCHSD) EHR for 150 youth with IDDs presenting to the ED for MHCs. This experimental group will be compared to two historical groups of youth from the RCHSD EHR: 1)~4000 youth with IDDs and psychiatric comorbidities but no history of MHCs and 2) ~4000 youth with IDDs without any psychiatric history. A machine learning-based network model will be used to classify psychiatric outcomes for youth with IDDs and perform leave-one-out cross validation to estimate the performance of these models and calculate metrics of classification performance. WGS will be completed for the cohort of 150 youth and neuropsychiatric polygenic scores (PGS) will be derived and their effect sizes compared to two groups of youth with IDDs from the Simons Simplex Collection: 1) ~50 youth with IDDs and severe psychiatric comorbidities and 2) ~1000 youth with IDDs and minimal or no psychiatric comorbidities. The rate of pathogenic rare variants will also be compared across cohorts. By applying machine learning methods to EHR data leveraging WGS, a combination of factors will be identified that predict psychiatric outcomes in youth with IDDs with high accuracy to allow for earlier intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05471232
Study type Observational
Source Rady Pediatric Genomics & Systems Medicine Institute
Contact Aaron Besterman, MD
Phone 858-576-1700
Email abesterman@health.ucsd.edu
Status Recruiting
Phase
Start date March 29, 2023
Completion date July 1, 2027

See also
  Status Clinical Trial Phase
Recruiting NCT05935722 - Evaluation of a Home-based Parenting Support Program: Parenting Young Children N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Active, not recruiting NCT03548779 - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2 N/A
Completed NCT03722212 - Early Diagnosis of the GLUT1 Deficiency Syndrome With a Blood Based Test N/A
Not yet recruiting NCT03644797 - Second Molecular Event Identification by Exome Sequencing for Intellectually Disabled Patients Carrying 16p13.11 CNVs
Not yet recruiting NCT02881333 - Various Type of Genetic Events in Patients With Intellectual Disability N/A
Completed NCT03139760 - POWERSforID: A Telehealth Weight Management System for Adults With Intellectual Disability N/A
Completed NCT02746614 - Psychomotor Therapy Effects in Adaptive Behavior and Motor Proficiency in Intellectual Disability N/A
Completed NCT06097819 - Therapy-Based Games' Effects on Motor and Cognitive Skills in Intellectual Disabilities N/A
Recruiting NCT05767203 - Genetic Markers and Biomarkers in Patients With Intellectual Disabilities of Genetic Origin N/A
Terminated NCT05445596 - Improving Treatment for Children With Intellectual and Developmental Disabilities and Problem Behavior in Schools N/A
Recruiting NCT05131425 - Facing Your Fears: Adolescents With ASD and Intellectual Disability N/A
Completed NCT04436692 - Dietary Intervention and Adults With Intellectual Disabilities N/A
Completed NCT04917666 - Process and Outcomes of Horticultural Therapy for People With Disabilities N/A
Completed NCT04518358 - Expert Guiding Technology to Help Individuals With Developmental Challenges Build Life and Vocational Skills N/A
Completed NCT04554355 - Effects of a PA Intervention for Fatness and Fitness in Adolescents With Intellectual Disability N/A
Completed NCT04277130 - Effectiveness of Active Video Games in Children With Intellectual Disabilities N/A
Enrolling by invitation NCT02914951 - Cognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability N/A
Completed NCT02591446 - Transcranial Magnetic Stimulation Studies in Autism Spectrum Disorders N/A
Completed NCT02304302 - Down Syndrome Memantine Follow-up Study Phase 2