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Generalized Anxiety DisorderNCT01032473

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

An observational study of Generalized Anxiety Disorder and Sleep Disturbances, run by Children's National Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
How many people
80 participants
Where
1 siteUnited States
Study dates
Aug 2009to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Community sample

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Candice Alfano, Ph.D. contact

(202) 476-6821

calfano@cnmc.org

United States1 site, 1 recruiting
  • Children's National Medical Center

    Washington D.C., District of Columbia, 20008

    Candice Alfano, Ph.D., 202-476-6821, calfano@cnmc.org

    Candice Alfano, Ph.D.

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Medical subject headings
Generalized Anxiety Disorder, Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01032473
Study groupRoleWhat they receive
GADChildren between the ages of 7-11 years diagnosed with Generalized Anxiety Disorder (GAD)
ControlChildren 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2009 (estimated)
  2. Study startAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01032473
Sponsor's protocol ID
CNMC-9978
Status last verified
May 2011
First submitted
14 Dec 2009
Last updated
12 May 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Generalized Anxiety Disorder and Sleep Disturbances, run by Children's National Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Candice Alfano, Ph.D. ((202) 476-6821, calfano@cnmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.

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