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Completed

NCT Number: NCT02415647

Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Upstate Medical University

Syracuse, New York, 13215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Apr 14, 2015
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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