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Individual and Family Therapy for Children With Anxiety Disorders

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Individual Child CBT
Family CBT
Education/Support/Attention
Sponsored by
Temple University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

9 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University Child and Adolescent Anxiety Disorders Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 9, 2004
Last Updated
March 5, 2014
Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00081406
Brief Title
Individual and Family Therapy for Children With Anxiety Disorders
Official Title
Child and Family Therapy for Anxiety-Disordered Youth
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Temple University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Individual Child CBT
Intervention Type
Behavioral
Intervention Name(s)
Family CBT
Intervention Type
Behavioral
Intervention Name(s)
Education/Support/Attention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Temple University Child and Adolescent Anxiety Disorders Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8034812
Citation
Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
Results Reference
background
PubMed Identifier
9170760
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. doi: 10.1037//0022-006x.65.3.366.
Results Reference
background
Links:
URL
http://www.childanxiety.org
Description
Web site for Child and Adolescent Anxiety Disorders Clinic at Temple University

Learn more about this trial

Individual and Family Therapy for Children With Anxiety Disorders

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