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



Status:Recruiting
Conditions:Anxiety, Insomnia Sleep Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:7 - 11
Updated:4/2/2016
Start Date:August 2009
Contact:Candice Alfano, Ph.D.
Email:calfano@cnmc.org
Phone:(202) 476-6821

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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.

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.

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
We found this trial at
1
site
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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