Clinical trial NCT01032473: Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD)
Official title: Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Generalized Anxiety Disorder
Sleep Disturbances
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: Children's National Research Institute
name: Candice Alfano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: