Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD)
Recruitment status was Recruiting
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Purpose
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.
| Condition |
|---|
|
Generalized Anxiety Disorder Sleep Disturbances |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Mechanisms of Sleep Disturbance in Children With Generalized Anxiety Disorder (GAD) |
Salivary cortisol
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2009 |
| Groups/Cohorts |
|---|
|
GAD
Children between the ages of 7-11 years diagnosed with Generalized Anxiety Disorder (GAD)
|
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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).
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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| Ages Eligible for Study: | 7 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Community sample
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
Contacts and Locations| Contact: Candice Alfano, Ph.D. | (202) 476-6821 | calfano@cnmc.org |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20008 | |
| Contact: Candice Alfano, Ph.D. 202-476-6821 calfano@cnmc.org | |
| Principal Investigator: Candice Alfano, Ph.D. | |
| Principal Investigator: | Candice Alfano, Ph.D. | Children's Research Institute |
More Information
No publications provided
| Responsible Party: | Candice Alfano, Ph.D., Children's National Medical Center |
| ClinicalTrials.gov Identifier: | NCT01032473 History of Changes |
| Other Study ID Numbers: | CNMC-9978 |
| Study First Received: | December 14, 2009 |
| Last Updated: | May 11, 2011 |
| Health Authority: | United States: Institutional Review Board United States: National Institute of Mental Health |
Additional relevant MeSH terms:
|
Anxiety Disorders Sleep Disorders Dyssomnias Parasomnias |
Mental Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013