We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Children's Research Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032473
First Posted: December 15, 2009
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Research Institute
  Purpose
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.

Condition
Generalized Anxiety Disorder Sleep Disturbances

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Biospecimen Retention:   Samples Without DNA
Salivary cortisol

Estimated Enrollment: 80
Study Start Date: August 2009
Groups/Cohorts
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).

Detailed Description:

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.

To qualify for this study, participants must first be evaluated via a brief, telephone screening. Qualified families will be invited for a comprehensive diagnostic interview. All parents and children must sign a written consent/assent in order to participate.

Two groups of children are being recruited: children diagnosed with (a primary diagnosis of) GAD and matched, healthy controls. To be included in the GAD group, children must:

  • Meet DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD)
  • 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

Participation is voluntary. Families who choose to participate will be asked to make two visits to Children's National. During their first visit, children and caregivers will be asked to complete self- and parent-report forms, as well as diagnostic interviews. Children will also be administered an abbreviated intelligence test. During their second visit, which is an optional component of the study, participants (and one parent) will stay overnight at Children's National and children will undergo an overnight sleep (polysomnographic) evaluation. Between these visits, participants will wear wrist actigraphs for seven days. An actigraph is a small device that looks like a watch and measures sleep and wake periods. Families will be called daily during this week-long assessment and administered a brief phone-based assessment regarding children's anxiety symptoms. Participants will receive some compensation for time and travel.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032473


Contacts
Contact: Candice Alfano, Ph.D. (202) 476-6821 calfano@cnmc.org

Locations
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20008
Contact: Candice Alfano, Ph.D.    202-476-6821    calfano@cnmc.org   
Principal Investigator: Candice Alfano, Ph.D.         
Sponsors and Collaborators
Children's Research Institute
Investigators
Principal Investigator: Candice Alfano, Ph.D. Children's Research Institute
  More Information

Responsible Party: Candice Alfano, Ph.D., Children's National Medical Center
ClinicalTrials.gov Identifier: NCT01032473     History of Changes
Other Study ID Numbers: CNMC-9978
First Submitted: December 14, 2009
First Posted: December 15, 2009
Last Update Posted: May 12, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Dyssomnias
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms