Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders

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	Complete list of historical versions of study NCT00517244 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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