- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00073645
Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
August 19, 2013 updated by: Florida International University
Therapy Specificity and Mediation in Family and Group CBT
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33174
- Florida International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
|
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
|
Children will be trained to be more helpful and positive toward other children through role-playing activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)
Time Frame: pre, post, and followup
|
pre, post, and followup
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
pre, post, followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy K. Silverman, PhD, Florida International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
December 2, 2003
First Submitted That Met QC Criteria
December 2, 2003
First Posted (Estimate)
December 3, 2003
Study Record Updates
Last Update Posted (Estimate)
August 20, 2013
Last Update Submitted That Met QC Criteria
August 19, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH063997 (U.S. NIH Grant/Contract)
- DSIR 84-CTS (Division of Services and Intervention Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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