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Clinical Trials/NCT00078728
NCT00078728
Completed
Not Applicable

Family-Based Prevention for Childhood Anxiety

Johns Hopkins University1 site in 1 country40 target enrollmentSeptember 2003

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety Disorders
Sponsor
Johns Hopkins University
Enrollment
40
Locations
1
Primary Endpoint
Number of Children With Child Anxiety Diagnosis
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Detailed Description

Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care. Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Registry
clinicaltrials.gov
Start Date
September 2003
End Date
July 2007
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Mothers with a current, primary anxiety disorder
  • 7-12 year old children without an anxiety disorder

Exclusion Criteria

  • Mothers that do not have a current, primary anxiety disorder
  • 7-12 year old children with an anxiety disorder
  • 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study

Outcomes

Primary Outcomes

Number of Children With Child Anxiety Diagnosis

Time Frame: 12 month

Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.

Child Anxiety Diagnoses

Time Frame: 12 months

The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.

Study Sites (1)

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