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

Anxiety Disorders Clinical Trial

Official title:

Therapy Specificity and Mediation in Family and Group CBT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073645
• Other study ID #: R01MH063997
• Secondary ID: R01MH063997DSIR
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2003
• Last updated: August 19, 2013
• Start date: July 2002
• Est. completion date: July 2008

Study information

• Verified date: August 2013
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Peer/Group CBT
Children will be trained to be more helpful and positive toward other children through role-playing activities.
• Family/Parents CBT
Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.

Locations

Country	Name	City	State
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida International University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)		pre, post, and followup	No
Secondary	Children's Manifest Anxiety Scale - Revised (RCMAS; Reynolds & Richmond, 1978) and Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach, 1991)		pre, post, followup	No