Mental Health Crises in Youth With IDDs

NCT05471232 | Recruiting

• 1 other identifier: 801938
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  4 years

Secondary Outcomes (1)

• Adjusted Relative Risk of Neuropsychiatric Polygenic Scores

  4 years

Other Outcomes (1)

• Diagnostic Rate

  4 years

Study Arms (2)

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.

Genetic: Genomic sequencing and molecular diagnostic results, if any.; Other: EHR-Based Network Model

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. GENETIC

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

Also known as: Pediatric Precision Medicine

Enrollees

EHR-Based Network Model OTHER

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

Enrollees

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children/adolescents admitted to the RCHSD ED with an IDD presenting in a MHC

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rady Pediatric Genomics & Systems Medicine Institute: lead

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Using whole genome sequencing, with biospecimens stored at RCIGM laboratory, evaluate the rate of pathogenic rare variants detected between cohorts.

MeSH Terms

Conditions

Intellectual Disability; Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Aaron Besterman, MD, MD

  Rady Children's Institute for Genomic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aaron Besterman, MD

CONTACT

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

Corrine Blucher, BS

CONTACT

858-576-1700; cblucher@rchsd.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, Clinical Investigator

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 22, 2022
• Study Start: March 29, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)