NCT00073645

Brief Summary

This study will compare the effectiveness of family- and peer-oriented therapy in treating children with anxiety disorders and will also test for therapy specificity effects and potential mediators of outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

5.4 years

First QC Date

December 2, 2003

Last Update Submit

August 19, 2013

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

  • ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)

    pre, post, and followup

Secondary Outcomes (1)

  • Children's Manifest Anxiety Scale - Revised (RCMAS; Reynolds & Richmond, 1978) and Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach, 1991)

    pre, post, followup

Study Arms (2)

1

EXPERIMENTAL

Family/Parents CBT (FCBT) for 14 to 16 weekly sessions

Behavioral: Family/Parents CBT

2

ACTIVE COMPARATOR

Peer/Group CBT (GCBT) for 14 to 16 weekly sessions

Behavioral: Peer/Group CBT

Interventions

Peer/Group CBTBEHAVIORAL

Children will be trained to be more helpful and positive toward other children through role-playing activities.

2
Family/Parents CBTBEHAVIORAL

Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.

1

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • DSM-IV criteria for Generalized Anxiety Disorder (GAD), Social Phobia (SP), or Separation Anxiety Disorder (SAD)
  • Mean score \>= 4 on the Clinician's Rating Scale of Severity
  • Discontinuation of all other psychosocial treatment upon consultation with clinic staff and the service provider

You may not qualify if:

  • DSM-IV criteria for a disorder other than GAD, SP, and SAD
  • Diagnosis of any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, or schizophrenia and other psychotic disorders
  • At risk for harm to self or others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University

Miami, Florida, 33174, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Wendy K. Silverman, PhD

    Florida International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2003

First Posted

December 3, 2003

Study Start

July 1, 2002

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

US(1)