Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders

• ClinicalTrials.gov Identifier: NCT00517244
• Recruitment Status: Completed
• First Posted: August 16, 2007
• Last Update Posted: March 11, 2016
• Sponsor: Rhode Island Hospital
• 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
• 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

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

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