Expired Study
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Philadelphia, Pennsylvania 19122


Purpose:

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


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

R01 MH59087


NCT ID:

NCT00081406


Secondary ID:

R01MH059087


Study Acronym:


Brief Title:

Individual and Family Therapy for Children With Anxiety Disorders


Official Title:

Child and Family Therapy for Anxiety-Disordered Youth


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

9 Years


Maximum Age:

13 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Temple University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:


Study Dates

Start Date:July 2000
Verification Date:March 2005
Last Changed Date:March 5, 2014
First Received Date:April 9, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Individual Child CBT
Intervention Type:Behavioral
Name:Family CBT
Intervention Type:Behavioral
Name:Education/Support/Attention

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Temple University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10.
PMID:8034812
Reference Type:Reference
Citation: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.
PMID:9170760

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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