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

NCT ID: NCT01032473

Last Updated: 2011-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31

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.

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.

Conditions

Generalized Anxiety Disorder; Sleep Disturbances

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

GAD

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

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Children's National Medical Center

Principal Investigators

Candice Alfano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Candice Alfano, Ph.D.

Role: CONTACT

calfano@cnmc.org

(202) 476-6821

Facility Contacts

Candice Alfano, Ph.D.

Role: primary

calfano@cnmc.org

202-476-6821

Other Identifiers

CNMC-9978

Identifier Type: -

Identifier Source: org_study_id