Recruiting

Observational Study

Sponsor:

Rady Pediatric Genomics & Systems Medicine Institute

Code:

NCT05471232

Conditions

Intellectual Disability

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Genomic sequencing and molecular diagnostic results, if any.

EHR-Based Network Model

Study Details

Brief 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

Conditions

Intellectual Disability

Study ID

NCT05471232

Start date

Mar 29, 2023

Status verified date

Aug, 2024

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrollees

These participants will be subject to whole genome sequencing to identify genetic changes and a EHR-Based network model to predict psychiatric outcomes in youth with IDDs.

Historical Control Group

A historical control group from public databases will be used to compare against enrollees.

Interventions

Genomic sequencing and molecular diagnostic results, if any.

Genomic sequencing results may be used for diagnosis and treatment of participants.

EHR-Based Network Model

EHR-based network will be created to predict psychiatric outcomes in youth with IDDs

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Aaron Besterman, MD

858-576-1700abesterman@health.ucsd.edu

Corrine Blucher, BS

858-576-1700cblucher@rchsd.org

Locations

Rady Children's Hospital San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Aaron Besterman, MD, MD

858-494-2429abesterman@health.ucsd.edu

Corrine Blucher, BS

8585761700cblucher@rchsd.org

More Information

Sponsor

Rady Pediatric Genomics & Systems Medicine Institute

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • Genomic
  • Intellectual and Developmental Disability
  • Mental Health Crisis
  • Pediatric
  • Rady Children's Hospital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rady Pediatric Genomics & Systems Medicine Institute on 2024-08-09.