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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00081406
Other study ID # R01MH059087
Secondary ID R01MH059087DSIR
Status Completed
Phase Phase 2/Phase 3
First received April 9, 2004
Last updated March 5, 2014
Start date July 2000

Study information

Verified date March 2005
Source Temple University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children.


Description:

Children and their parents will complete a comprehensive diagnostic assessment to determine eligibility. The assessment will include an individual diagnostic interview with the child, interviews with the parents, and written observations of the child from family members and teachers. Participants will then be randomly assigned to receive individual cognitive behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5 months. Children in the ICBT group will meet individually with a therapist. In the FCBT and ESA treatment groups, children and their parents will meet weekly with a therapist.

At the end of treatment and 1 year following treatment completion, families will complete another assessment to determine the effectiveness of each treatment at reducing short- and long-term anxiety symptoms in their children.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 9 Years to 13 Years
Eligibility Inclusion Criteria:

- Child with DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria for Child Participants:

- IQ less than 80

- Current use of anti-anxiety or antidepressant medications

- Psychotic symptoms

- Child and/or parent is non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Individual Child CBT

Family CBT

Education/Support/Attention


Locations

Country Name City State
United States Temple University Child and Adolescent Anxiety Disorders Clinic Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kendall PC, Flannery-Schroeder E, Panichelli-Mindel SM, Southam-Gerow M, Henin A, Warman M. Therapy for youths with anxiety disorders: a second randomized clinical trial. J Consult Clin Psychol. 1997 Jun;65(3):366-80. — View Citation

Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. — View Citation

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