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

Sponsor

Florida International University (Other)

Overall Status

Completed

CT.gov ID

NCT00073645

Collaborator

National Institute of Mental Health (NIMH) (NIH)

241

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Behavioral: Peer/Group CBT Behavioral: Family/Parents CBT	Phase 1

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

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Therapy Specificity and Mediation in Family and Group CBT

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Family/Parents CBT (FCBT) for 14 to 16 weekly sessions	Behavioral: Family/Parents CBT Parents will be trained to manage their children's anxiety and avoidant behaviors by increasing acceptance and warmth toward their children.
Active Comparator: 2 Peer/Group CBT (GCBT) for 14 to 16 weekly sessions	Behavioral: Peer/Group CBT Children will be trained to be more helpful and positive toward other children through role-playing activities.

Arm

Intervention/Treatment

Experimental: 1

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

Behavioral: Family/Parents CBT

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

Active Comparator: 2

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

Behavioral: Peer/Group CBT

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

Outcome Measures

Primary Outcome Measures

ADIS C/P Interference Rating Scales (Silverman & Albano, 1996) [pre, post, and followup]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida International University	Miami	Florida	United States	33174

Sponsors and Collaborators

Florida International University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Wendy K. Silverman, PhD, Florida International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00073645

Other Study ID Numbers:

R01MH063997
R01MH063997
DSIR 84-CTS

First Posted:

Dec 3, 2003

Last Update Posted:

Aug 20, 2013

Last Verified:

Aug 1, 2013

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Aug 20, 2013