| City: |
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Washington |
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State:
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DC |
| Zip Code: |
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20008 |
| Conditions: |
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Generalized Anxiety Disorder - Sleep Disturbances |
| Purpose: |
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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.
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| Study summary: |
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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.
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,
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. |
| Criteria: |
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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 |
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| Study is available at: |
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Children's National Medical Center
Washington, DC 20008
United States
Primary Contact:
Candice Alfano, Ph.D.
Email: calfano@cnmc.org
Phone: 202-476-6821
Secondary Contact:
Candice Alfano, Ph.D.
Email: calfano@cnmc.org
Phone: (202) 476-6821 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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