NCT00001654

Brief Summary

The dysregulated experience and expression of emotion is implicated in psychiatric disorders associated both with externalizing problems (aggressive, antisocial behaviors) and internalizing problems (anxiety, depression). Adolescence is a critical juncture in the development of these disorders because of the increased incidence and differentiation of clinical problems during this time period. This is a biobehavioral, longitudinal investigation of the role of emotion in the development of psychopathology in adolescence. The focus is on socialization experiences and biological processes that contribute to emotion dysregulation and disorder in male and female youths between 11 and 16 years of age. Groups studied include (1) comorbid externalizers and internalizers, (2) externalizers only, (3) internalizers only, and (4) asymptomatic youth. The adolescents are assessed again two years later, with instruments and paradigms similar to those used at Time 1. One theme pertains to the integration and disconnection of emotions across systems (e.g., physiological and self-report of experience), and how different patterns of emotion relate to psychopathology. A second theme pertains to development changes in how disorders are manifested (e.g., increased differentiation along gender specific pathways). The anticipated number of patient days per year is 240 for adolescents and mothers, and 120 days for fathers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1997

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

May 1, 1997

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

AdolescenceComorbid DisordersPhysiologySocializationGenderConduct ProblemsAnxietySadnessEmotionPsychophysiology

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects and their families will be recruited from the community.
  • Individuals meeting entry criteria will be offered entry into the study, and others will be notified.

You may not qualify if:

  • A debilitating physical impairment (e.g., seizure disorder, cerebral palsy, head trauma).
  • Significant intellectual impairment (i.e., IQ less than 70).
  • History of psychosis.
  • Any condition that would impair a participant's ability to respond to the study's paradigms will be excluded from this study at the time of screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Akil H, Haskett RF, Young EA, Grunhaus L, Kotun J, Weinberg V, Greden J, Watson SJ. Multiple HPA profiles in endogenous depression: effect of age and sex on cortisol and beta-endorphin. Biol Psychiatry. 1993 Jan 15;33(2):73-85. doi: 10.1016/0006-3223(93)90305-w.

    PMID: 8382535BACKGROUND
  • Angold A, Costello EJ. Depressive comorbidity in children and adolescents: empirical, theoretical, and methodological issues. Am J Psychiatry. 1993 Dec;150(12):1779-91. doi: 10.1176/ajp.150.12.1779.

    PMID: 8238631BACKGROUND
  • Anderson JC, Williams S, McGee R, Silva PA. DSM-III disorders in preadolescent children. Prevalence in a large sample from the general population. Arch Gen Psychiatry. 1987 Jan;44(1):69-76. doi: 10.1001/archpsyc.1987.01800130081010.

    PMID: 2432848BACKGROUND

MeSH Terms

Conditions

Mood DisordersCoitusAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSexual BehaviorBehavior

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 1, 1997

Study Completion

May 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-05

Locations