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NCT00517244 Clinical Trial

Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders

Anxiety Disorders Clinical Trial

Official title:
Child Anxiety Disorders: Parenting and Temperament Effects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00517244
Other study ID # K23MH071754
Secondary ID K23MH071754DDTR
Status Completed
Phase N/A
First received August 14, 2007
Last updated March 10, 2016
Start date October 2006
Est. completion date April 2014

Study information
Verified date March 2016
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

This study will look at similarities and differences in family processes and child temperament among children with and without symptoms of anxiety disorders.

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.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 12 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Pediatric Anxiety Research Center/Bradley Hospital/Brown Medical School Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Rhode Island Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Parenting styles and child temperaments associated with child anxiety disorders Measured at completion of treatment analysis No
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