Intellectual DisabilityNCT05471232
Mental Health Crises in Youth With IDDs
An observational study of Intellectual Disability, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Genomic sequencing and molecular diagnostic results, if any. and EHR-Based Network Model
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children/adolescents admitted to the RCHSD ED with an IDD presenting in a MHC
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Aaron Besterman, MD, MD, 858-494-2429, abesterman@health.ucsd.edu
Corrine Blucher, BS, 8585761700 ext. 221632, cblucher@rchsd.org
About this study
Official title: Understanding Mental Health Crises in Youth With Intellectual and Developmental Disabilities
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
Read the detailed 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.
- Conditions
- Intellectual Disability
- Being tested
- Genomic sequencing and molecular diagnostic results, if any., EHR-Based Network Model
- Keywords
- Genomic, Intellectual and Developmental Disability, Mental Health Crisis, Pediatric, Rady Children's Hospital
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic sequencing and molecular diagnostic results, if any.Genetic
Also called Pediatric Precision Medicine
Genomic sequencing results may be used for diagnosis and treatment of participants.
EHR-Based Network ModelOther
EHR-based network will be created to predict psychiatric outcomes in youth with IDDs
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start29 Mar 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Besterman, Rady Pediatric Genomics & Systems Medicine Institute
- Investigators
- Aaron Besterman, MD, MD, Principal investigator, Rady Children's Institute for Genomic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471232
- Sponsor's protocol ID
- 801938
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Mental Health Crises in Youth With Intellectual and Developmental Disabilities
- ClinicalTrials.gov ID
- NCT05471232
- Acronym / sponsor ID
- 801938
- Conditions
- Intellectual Disability
- Keywords
- Genomic, Intellectual and Developmental Disability, Mental Health Crisis, Pediatric, Rady Children's Hospital
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rady Pediatric Genomics & Systems Medicine InstituteUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enrollees | – | Genetic: Genomic sequencing and molecular diagnostic results, if any., Other: EHR-Based Network ModelThese 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children/adolescents admitted to the RCHSD ED with an IDD presenting in a MHC
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genomic sequencing and molecular diagnostic results, if any.Also: Pediatric Precision MedicineGenomic sequencing results may be used for diagnosis and treatment of participants. | Genetic | Enrollees |
| EHR-Based Network ModelEHR-based network will be created to predict psychiatric outcomes in youth with IDDs | Other | Enrollees |
Primary outcome
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
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.
1 secondary outcome
Adjusted Relative Risk of Neuropsychiatric Polygenic Scores
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Besterman, MD, MD principal investigator
Rady Children's Institute for Genomic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Besterman, MD (858-576-1700 ext. 221633, abesterman@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.