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

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.

Study Overview

• Status: Unknown
• Conditions: Generalized Anxiety Disorder; Sleep Disturbances

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Candice Alfano, Ph.D.; Phone Number: (202) 476-6821; Email: calfano@cnmc.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20008
      • Recruiting
      • Children's National Medical Center
      • Contact: Candice Alfano, Ph.D.; Phone Number: 202-476-6821; Email: calfano@cnmc.org
      • Principal Investigator: Candice Alfano, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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).

Collaborators and Investigators

• Sponsor: Children's National Research Institute
• Investigators: Principal Investigator: Candice Alfano, Ph.D., Children's National Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 2009

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 11, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Anxiety Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: CNMC-9978