Individual and Family Therapy for Children With Anxiety D... | NCT00081406

Studies
Individual and Family Therapy for Children With Anxiety Disorders

NCT00081406

Sponsor

Temple University

Status

Completed

Last Update Posted

Mar 6, 2014Estimated

Enrollment

150

Phase

Phase 2Phase 3

Conditions

Anxiety

Interventions

Individual Child CBT
Family CBT
Education/Support/Attention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH059087	U.S. NIH Grant/Contract		View source
DSIR CT-S

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2000

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 9, 2004

First Submission Date that Met QC Criteria

Apr 9, 2004

First Posted Date

Apr 12, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2014

Last Update Posted Date

Mar 6, 2014Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University Child and Adolescent Anxiety Disorders Clinic		Philadelphia	Pennsylvania	19122	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8034812	Background	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.
9170760	Background	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.

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Name	Type	Description	Arm Group Labels	Other Names
Individual Child CBT	Behavioral
Family CBT	Behavioral
Education/Support/Attention	Behavioral