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

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ClinicalTrials.gov Identifier: NCT00073645
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : August 20, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Florida International University

Tracking Information
First Submitted Date  ICMJE December 2, 2003
First Posted Date  ICMJE December 3, 2003
Last Update Posted Date August 20, 2013
Study Start Date  ICMJE July 2002
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996) [ Time Frame: pre, post, and followup ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00073645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
Official Title  ICMJE Therapy Specificity and Mediation in Family and Group CBT
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE
  • Behavioral: Peer/Group CBT
    Children will be trained to be more helpful and positive toward other children through role-playing activities.
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
    Intervention: Behavioral: Family/Parents CBT
  • Active Comparator: 2
    Peer/Group CBT (GCBT) for 14 to 16 weekly sessions
    Intervention: Behavioral: Peer/Group CBT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2013)
241
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
250
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00073645
Other Study ID Numbers  ICMJE R01MH063997( U.S. NIH Grant/Contract )
R01MH063997 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wendy Silverman, PhD, Florida International University
Study Sponsor  ICMJE Florida International University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Wendy K. Silverman, PhD Florida International University
PRS Account Florida International University
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP