Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Hessl, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00879515
First received: April 9, 2009
Last updated: March 5, 2013
Last verified: March 2013

April 9, 2009
March 5, 2013
October 2005
September 2010   (final data collection date for primary outcome measure)
Fear-potentiated startle reflex [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879515 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Examining Social, Emotional, and Cognitive Functioning in People With Fragile X and Down Syndromes
Genetics and Physiology of Social Anxiety in Fragile X

By testing physiological responses to anxiety in people with nervous system developmental disorders, this study will identify specific physiological characteristics associated with response to anxiety treatments.

Anxiety is a common and significant problem for people suffering from disorders of nervous system development, including fragile X syndrome. There are few validated treatments for anxiety in people with these disorders, in part because the biological basis of anxiety in neurodevelopmental disorders has not been clearly described. This study will evaluate the physiological responses of people with fragile X syndrome, Down syndrome, and the fragile X premutation (a mild version of the genes that cause fragile X syndrome) to a variety of sensory, emotional, and social stimuli. By analyzing the data collected for this study, researchers aim to identify physiological characteristics linked to subgroups within the disorders, demonstrate links between physiological responses and behavioral or psychiatric symptoms, and measure physiological changes in people receiving treatment for their disorders.

Participation in this study will include one testing session, which will take between 3 and 3.5 hours. Participants who receive treatment for their anxiety may be asked to complete this testing a second time, after their treatment. During the testing session, sensors will be placed on participants' skin in several locations to measure heart rate, sweat response, and eye-blinks. Participants will then be asked to respond to multiple stimuli: sounds, lights, smells, pictures that elicit different types of emotions, an interaction with an unfamiliar person, and specialized toys. In addition, participants will undergo blood testing and have several samples of their saliva collected on the day of the testing session. Participants will also be asked to collect additional saliva samples at home three times a day on 4 different days. Child participants and their parents may also be asked to complete questionnaires and interviews about behavioral and emotional problems.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Saliva samples collected at four time periods

Non-Probability Sample

Individuals with fragile X syndrome, Down syndrome, the fragile X premutation, and normal development

  • Anxiety Disorders
  • Child Developmental Disorders, Pervasive
Not Provided
  • 1
    Males and females with fragile X syndrome, ages 5 to 25 years old
  • 2
    Males and females with the FMR1 premutation, ages 5 to 25 year old
  • 3
    Males and females with Down syndrome, ages 5 to 25 years old
  • 4
    Males and females with normal development, ages 5 to 25 years old
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fragile X premutation or fragile X syndrome, measured by DNA testing; Down syndrome, confirmed by chromosomal analysis; or normally developing control
  • Normal hearing
Both
5 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00879515
K23 MH077554, K23MH077554, DDTR B2-MBA
Yes
David Hessl, MD, University of California, Davis
University of California, Davis
National Institute of Mental Health (NIMH)
Not Provided
University of California, Davis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP