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Clinical Trials/NCT00073645
NCT00073645CompletedPhase 1

Therapy Specificity and Mediation in Family and Group CBT

Florida International University1 site in 1 country241 target enrollmentStarted: July 1, 2002Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
241
Locations
1
Primary Endpoint
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

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

Intervention: Family/Parents CBT (Behavioral)

2

Active Comparator

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

Intervention: Peer/Group CBT (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: pre, post, and followup

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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