Recruiting

Observational Study

Sponsor:

Children's National Research Institute

Code:

NCT01032473

Conditions

Generalized Anxiety Disorder

Sleep Disturbances

Eligibility Criteria

Sex: All

Age: 7 - 11

Healthy Volunteers: Accepted

Study Details

Brief summary:

Anxiety disorders are among the most common mental disorders in children, affecting approximately 1 out of every 10 children and adolescents. Symptoms of anxiety disorders may include excessive fear/anxiety/worry, somatic complaints such as headaches and muscle aches, and impaired social and family relationships. Some children with anxiety also experience sleep problems, however, little is known about the sleep patterns of anxious children. The purpose of the study, conducted at Children's National Medical Center, is to examine the sleep characteristics of children with Generalized Anxiety Disorder (GAD) compared to a control group of children without GAD to see how sleep behaviors and daytime behaviors are related.

Conditions

Generalized Anxiety Disorder

Sleep Disturbances

Study ID

NCT01032473

Start date

Aug, 2009

Status verified date

May, 2011

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 11

Healthy Volunteers: Accepted

Inclusion Criteria:

To be included in the GAD group, children must:

  • Meet DSM-IV criteria for a primary diagnosis of generalized anxiety disorder
  • Be between the ages of 7 and 11 years old
  • Not take any psychotropic medications
  • Not have any chronic/major medical problems
  • Be of (at least) average intelligence (i.e., IQ of 80 or greater)
  • Not meet criteria for psychosis, bipolar, or major depressive disorder
  • Parents and children must be English speaking

To be included in the control group, children must:

  • Not meet criteria for a psychiatric or sleep disorder
  • Be between the ages of 7 and 11 years old
  • Not take any psychotropic medications
  • Not have any chronic/major medical problems
  • Be of (at least) average intelligence (i.e., IQ of 80 or greater)
  • Parents and children must be English speaking

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

GAD

Children between the ages of 7-11 years diagnosed with Generalized Anxiety Disorder (GAD)

Control

Children between the ages of 7-11 years free of significant medical or behavioral problems (matched to children diagnosed with GAD based on age, gender, and ethnicity).

Central Contacts and Locations

Central contacts

Candice Alfano, Ph.D.

(202) 476-6821calfano@cnmc.org

Locations

Children's National Medical Center

Recruiting

Washington, District of Columbia, United States, 20008

Contacts

Candice Alfano, Ph.D.

202-476-6821calfano@cnmc.org

Principal Investigator:

Candice Alfano, Ph.D.

More Information

Sponsor

Children's National Research Institute

Last update posted

May 12, 2011

Last verified

May, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2011-05-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.