NCT02415647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,806

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

March 31, 2015

Last Update Submit

May 14, 2024

Conditions

Mental DisordersPsychological DisordersPsychiatric, DiagnosisMental Disorders Diagnosed in Childhood

Keywords

childrenmental healthfamily genetic study

Outcome Measures

Primary Outcomes (4)

  • Reward Valuation

    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

    Baseline

  • Effort Valuation/Willingness to Work

    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

    Baseline

  • Expectancy/Reward Prediction Error

    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

    Baseline

  • Initial Responsiveness to Reward Attainment

    Measures: Self-report, computerized tests, and DNA samples; Assessing correlations among family members and predictors of psychopathology.

    Baseline

Study Arms (2)

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).

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • male or female, ages 6-12.
  • biological child of parent(s) participating in testing.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Medical University

Syracuse, New York, 13215, United States

Location

Related Publications (10)

  • Glatt SJ, Stone WS, Faraone SV, Seidman LJ, Tsuang MT. Psychopathology, personality traits and social development of young first-degree relatives of patients with schizophrenia. Br J Psychiatry. 2006 Oct;189:337-45. doi: 10.1192/bjp.bp.105.016998.

    PMID: 17012657BACKGROUND

  • Faraone SV, Seidman LJ, Kremen WS, Kennedy D, Makris N, Caviness VS, Goldstein J, Tsuang MT. Structural brain abnormalities among relatives of patients with schizophrenia: implications for linkage studies. Schizophr Res. 2003 Apr 1;60(2-3):125-40. doi: 10.1016/s0920-9964(02)00304-3.

    PMID: 12591577BACKGROUND

  • Faraone SV, Su J, Tsuang MT. A genome-wide scan of symptom dimensions in bipolar disorder pedigrees of adult probands. J Affect Disord. 2004 Oct;82 Suppl 1:S71-8. doi: 10.1016/j.jad.2004.05.015.

    PMID: 15571792BACKGROUND

  • Glatt SJ, Su JA, Zhu SC, Zhang R, Zhang B, Li J, Yuan X, Li J, Lyons MJ, Faraone SV, Tsuang MT. Genome-wide linkage analysis of heroin dependence in Han Chinese: results from wave one of a multi-stage study. Am J Med Genet B Neuropsychiatr Genet. 2006 Sep 5;141B(6):648-52. doi: 10.1002/ajmg.b.30361.

    PMID: 16856125BACKGROUND

  • Glatt SJ, Faraone SV, Lasky-Su JA, Kanazawa T, Hwu HG, Tsuang MT. Family-based association testing strongly implicates DRD2 as a risk gene for schizophrenia in Han Chinese from Taiwan. Mol Psychiatry. 2009 Sep;14(9):885-93. doi: 10.1038/mp.2008.30. Epub 2008 Mar 11.

    PMID: 18332877BACKGROUND

  • Cross-Disorder Group of the Psychiatric Genomics Consortium. Identification of risk loci with shared effects on five major psychiatric disorders: a genome-wide analysis. Lancet. 2013 Apr 20;381(9875):1371-1379. doi: 10.1016/S0140-6736(12)62129-1. Epub 2013 Feb 28.

    PMID: 23453885BACKGROUND

  • Faraone SV, Matise T, Svrakic D, Pepple J, Malaspina D, Suarez B, Hampe C, Zambuto CT, Schmitt K, Meyer J, Markel P, Lee H, Harkavy Friedman J, Kaufmann C, Cloninger CR, Tsuang MT. Genome scan of European-American schizophrenia pedigrees: results of the NIMH Genetics Initiative and Millennium Consortium. Am J Med Genet. 1998 Jul 10;81(4):290-5.

    PMID: 9674973BACKGROUND

  • Faraone SV, Biederman J, Mick E, Wozniak J, Kiely K, Guite J, Ablon JS, Warburton R, Reed E. Attention deficit hyperactivity disorder in a multigenerational pedigree. Biol Psychiatry. 1996 May 15;39(10):906-8. doi: 10.1016/0006-3223(95)00194-8. No abstract available.

    PMID: 8860195BACKGROUND

  • Faraone SV, Adamson JJ, Wilens TE, Monuteaux MC, Biederman J. Deriving phenotypes for molecular genetic studies of substance use disorders: a family study approach. Drug Alcohol Depend. 2007 May 11;88(2-3):244-50. doi: 10.1016/j.drugalcdep.2006.11.002. Epub 2006 Dec 1.

    PMID: 17141426BACKGROUND

  • Faraone SV, Adamson JJ, Wilens TE, Monuteaux MC, Biederman J. Familial transmission of derived phenotypes for molecular genetic studies of substance use disorders. Drug Alcohol Depend. 2008 Jan 1;92(1-3):100-7. doi: 10.1016/j.drugalcdep.2007.07.002. Epub 2007 Sep 4.

    PMID: 17766060BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples.

MeSH Terms

Conditions

Mental DisordersNeurodevelopmental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Stephen Faraone, Ph.D.

    Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 14, 2015

Study Start

October 1, 2014

Primary Completion

September 13, 2018

Study Completion

May 31, 2020

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

US(1)