Longitudinal Family/Molecular Genetic Study to Validate Research Domain Criteria

Completed

• Conditions: Mental Disorders; Psychiatric, Diagnosis; Psychological Disorders; Mental Disorders Diagnosed in Childhood

• Registration Number: NCT02415647
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Primary Completion: 2018-09-13
• Study Completion: 2020-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2806

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reward Valuation	Baseline	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Initial Responsiveness to Reward Attainment	Baseline	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Effort Valuation/Willingness to Work	Baseline	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.
Expectancy/Reward Prediction Error	Baseline	Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

Trial Locations

Locations (1)

Upstate Medical University; 🇺🇸 Syracuse, New York, United States