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Family and Peer Involvement in the Treatment of Anxiety Disorders in Children

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Peer/Group CBT
Family/Parents CBT
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Florida International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2003
Last Updated
August 19, 2013
Sponsor
Florida International University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00073645
Brief Title
Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
Official Title
Therapy Specificity and Mediation in Family and Group CBT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Data suggest that individual Cognitive Behavior Therapy (CBT) is effective in reducing anxiety disorders in children. The incorporation of parents and peers in a CBT treatment program also has been found to be effective in reducing anxiety symptoms, because a child's environment (i.e., parents, peers) affect the development, course, and outcome of childhood anxiety and functional status. Children and their parents will be randomly assigned to one of two treatment conditions: Family/Parents CBT (FCBT) or Peer/Group CBT (GCBT) for 14 to 16 weekly sessions. Parent-child relationships are the focus of FCBT. Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children. Children in the GCBT group will be trained to be more helpful and positive toward other children through role-playing activities. Interviews, questionnaires, and behavior observation tasks will be used to assess participants. All participants will be assessed at pretreatment, post-treatment, and at yearly follow-up visits. The first set of hypotheses that will be tested is that FCBT will produce significantly greater specific effects on parenting skills and parent-child relationships than on child social skills and peer-child relationships. GCBT, on the other hand, will produce significantly greater specific effects on child social skills and peer-child relationships than on parenting skills and parent-child relationships. The second set of hypotheses will test whether or not it is the changes that are produced on these variables that mediate treatment response. Thus, the second set of hypotheses that will be tested is that parenting skills, parent-child relationships, child social skills and/or peer-child relationships will be significant mediators of treatment response, i.e., anxiety reduction

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Peer/Group CBT (GCBT) for 14 to 16 weekly sessions
Intervention Type
Behavioral
Intervention Name(s)
Peer/Group CBT
Intervention Description
Children will be trained to be more helpful and positive toward other children through role-playing activities.
Intervention Type
Behavioral
Intervention Name(s)
Family/Parents CBT
Intervention Description
Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
Primary Outcome Measure Information:
Title
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)
Time Frame
pre, post, and followup
Secondary Outcome Measure Information:
Title
Children's Manifest Anxiety Scale - Revised (RCMAS; Reynolds & Richmond, 1978) and Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach, 1991)
Time Frame
pre, post, followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy K. Silverman, PhD
Organizational Affiliation
Florida International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida International University
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States

12. IPD Sharing Statement

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Family and Peer Involvement in the Treatment of Anxiety Disorders in Children

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