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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

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

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Study Type : Interventional  (Clinical Trial)
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 : July 2002
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. ADIS C/P Interference Rating Scales (Silverman & Albano, 1996) [ Time Frame: pre, post, and followup ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073645


Locations
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United States, Florida
Florida International University
Miami, Florida, United States, 33174
Sponsors and Collaborators
Florida International University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Wendy K. Silverman, PhD Florida International University

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Responsible Party: Wendy Silverman, PhD, Florida International University
ClinicalTrials.gov Identifier: NCT00073645     History of Changes
Other Study ID Numbers: R01MH063997 ( U.S. NIH Grant/Contract )
R01MH063997 ( U.S. NIH Grant/Contract )
DSIR 84-CTS
First Posted: December 3, 2003    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders