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Completed

NCT Number: NCT00073645

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

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.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Florida International University

Miami, Florida, 33174, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer/Group CBT

Behavioral

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

Family/Parents CBT

Behavioral

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

Primary outcomes

  1. ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)

    Time frame: pre, post, and followup

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Therapy Specificity and Mediation in Family and Group CBT

Important dates

Study start
2002
Primary completion
2007
Study completion
2008
First posted
Dec 3, 2003
Registry last updated
Aug 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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