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Trial record 37 of 138 for:    Mental Disorders | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

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ClinicalTrials.gov Identifier: NCT02415647
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephen V. Faraone, State University of New York - Upstate Medical University

Brief Summary:
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.

Condition or disease
Mental Disorders Psychological Disorders Psychiatric, Diagnosis Mental Disorders Diagnosed in Childhood

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
Estimated Enrollment : 2800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria
Study Start Date : October 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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).



Primary Outcome Measures :
  1. Reward Valuation [ Time Frame: Baseline ]
    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

  2. 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.

  3. Expectancy/Reward Prediction Error [ Time Frame: Baseline ]
    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

  4. 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.


Biospecimen Retention:   Samples With DNA
Whole blood samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415647


Contacts
Contact: Sarah Van Orman, LMSW 315-464-3289 vanormas@upstate.edu
Contact: Stephen Glatt, Ph.D. 315-464-7742 glatts@upstate.edu

Locations
United States, New York
Upstate Medical University Recruiting
Syracuse, New York, United States, 13215
Contact: Sarah Van Orman, LMSW    315-464-3289    vanormas@upstate.edu   
Contact: Stephen Glatt, Ph.D.    315-464-7742    glatts@upstate.edu   
Principal Investigator: Stephen Glatt, Ph.D.         
Sponsors and Collaborators
State University of New York - Upstate Medical University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Stephen Faraone, Ph.D. Upstate Medical University

Publications:

Responsible Party: Stephen V. Faraone, Faculty, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02415647     History of Changes
Other Study ID Numbers: 543389-8
R01MH101519-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Stephen V. Faraone, State University of New York - Upstate Medical University:
children
mental health
family genetic study

Additional relevant MeSH terms:
Disease
Mental Disorders
Psychotic Disorders
Neurodevelopmental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders