Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

October 3, 2017 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

Unknown

Conditions

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

Observational

Enrollment (Anticipated)

2800

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 Backup

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13215
        • Recruiting
        • Upstate Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Glatt, Ph.D.

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

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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
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

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

State University of New York - Upstate Medical University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • 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

October 1, 2014

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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