Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

May 14, 2024 updated by: Stephen V. Faraone, State University of New York - Upstate Medical University
The purpose of this research is to study new ways of classifying mental disorders in children based on observable behavior and genetics to ultimately diagnose these disorders better.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The NIMH Research Domain Criteria (RDoC) initiative seeks to further a long-range goal of contributing to diagnostic systems as informed by research on genetics, neuroscience, and behavior. The RDoC approach is based on identifying the most elemental units of analysis relevant to psychiatric disorders (such as genes and molecules) and using this matrix as a framework for investigation. In this case-control family study, the investigators will be using self-report questionnaires and computer-based tests to develop diagnostic methods for neuropsychiatric disorders in children, their siblings, and their parents. They will do this by recruiting "normal" and "affected" children, their siblings, and their parents. They will look at the subject, sibling, and parents to determine if psychiatric disorders are inherited. "Affected" children, ages 6-12, are those who have been diagnosed with a psychiatric disorder. Participants will undergo a battery of questionnaires/evaluations and a blood draw. The investigators will determine if the questionnaires and tests that reflect the constructs (such as reward prediction and willingness to work) predict psychopathology and impairment. The blood draw will be genotyped to determine if the measured constructs are associated with neuropsychiatric candidate genes, cross-disorder candidate gens and a cross-disorder polygenic score.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2806

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13215
        • Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Child probands with psychiatric disorders will be recruited from psychiatric clinics, child psychiatrists, and mental health providers in Onondaga County. Non-disordered psychiatrially normal comparison groups will be recruited from a pediatric primary care clinic.

Description

Inclusion Criteria:

  • male or female, ages 6-12.
  • biological child of parent(s) participating in testing.

Exclusion Criteria:

  • taking psychotropic medications.
  • free of uncontrolled medical problems.
  • major sensorimotor disability (e.g., deafness, blindness).
  • diagnosed neurological condition.
  • inadequate command of the English language.
  • history of head injury with loss of consciousness lasting longer than 10 minutes.
  • IQ estimated at below 80.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Child Proband with Psychiatric Disorder
Affected group of child probands with psychiatric disorders (ages 6-12 years).
Normal Comparison Group
Non-disordered psychiatrically normal comparison group (ages 6-12 years).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reward Valuation
Time Frame: Baseline
Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Baseline
Effort Valuation/Willingness to Work
Time Frame: Baseline
Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Baseline
Expectancy/Reward Prediction Error
Time Frame: Baseline
Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Baseline
Initial Responsiveness to Reward Attainment
Time Frame: Baseline
Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Faraone, Ph.D., Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 543389-8
  • R01MH101519-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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