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Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00517244
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : March 11, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Abbe Garcia, Rhode Island Hospital

Tracking Information
First Submitted Date August 14, 2007
First Posted Date August 16, 2007
Last Update Posted Date March 11, 2016
Study Start Date October 2006
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2007)
Parenting styles and child temperaments associated with child anxiety disorders [ Time Frame: Measured at completion of treatment analysis ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders
Official Title Child Anxiety Disorders: Parenting and Temperament Effects
Brief Summary This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders.
Detailed Description

Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal part of life and growing up, for some children this anxiety becomes chronic, relentless, and progressively worse if left untreated. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Effective treatments for anxiety disorders are available, and research continues to yield new, improved therapies that can help most people with anxiety disorders to lead productive, fulfilling lives. This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders. Results from this study may improve future treatment of children with anxiety disorders.

Families participating in this observational study will be mailed parent and child questionnaires that should be completed prior to the first study session. The child questionnaires will ask for information regarding the child's feelings and family interactions. Parent questionnaires will ask for information about their own personal feelings as well as the child's feelings, symptoms, and behaviors. Study participation will last 2 days. On the first day of the study, families will undergo a 3-hour diagnostic interview in which questions similar to those found on the questionnaires will be revisited. On the second day, mothers and their children will participate in three different observation tasks that explore how families interact and respond to certain situations. These tasks may include discussing certain anxiety-provoking situations, putting puzzles together, and creating an ending to a story. Before each task, the child will be placed alone in a separate room where the child will be asked to relax. Throughout the tasks, the child's heart rate and breathing will be recorded by a machine. The tasks will be videotaped but will be viewed only by research staff for data analysis purposes and to ensure that all safety procedures were followed. Upon study completion, if it appears that a child has an anxiety disorder, parents of the child will be notified and will receive treatment referrals as needed.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community Sample
Condition
  • Anxiety Disorders
  • Obsessive Compulsive Disorder
Intervention Not Provided
Study Groups/Cohorts
  • A
    Primary anxiety disorder
  • B
    Primary obsessive compulsive disorder
  • C
    Healthy children with no previous history of an anxiety disorder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 14, 2007)
180
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for Children:

  • English-speaking

Exclusion Criteria Children:

  • Mental retardation
  • Current or past diagnosis of autistic spectrum disorders
  • Current or past diagnosis of psychotic disorders
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 12 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00517244
Other Study ID Numbers K23MH071754( U.S. NIH Grant/Contract )
K23MH071754 ( U.S. NIH Grant/Contract )
DDTR B3-PDX
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbe Garcia, Rhode Island Hospital
Study Sponsor Rhode Island Hospital
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Abbe M. Garcia, PhD Brown Medical School/ Rhode Island Hospital
PRS Account Rhode Island Hospital
Verification Date March 2016