Skip to content

Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02415647
Enrollment
2806
Registered
2015-04-14
Start date
2014-10-31
Completion date
2020-05-31
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders, Mental Disorders Diagnosed in Childhood, Psychiatric, Diagnosis, Psychological Disorders

Keywords

children, mental health, family genetic study

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.

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.

Interventions

None listed

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Reward ValuationBaselineMeasures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Effort Valuation/Willingness to WorkBaselineMeasures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Expectancy/Reward Prediction ErrorBaselineMeasures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Initial Responsiveness to Reward AttainmentBaselineMeasures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026