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

Florida International University (FIU) logo

Florida International University (FIU)

Status and phase

Completed
Phase 1

Conditions

Anxiety Disorders

Treatments

Behavioral: Peer/Group CBT
Behavioral: Family/Parents CBT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00073645
R01MH063997 (U.S. NIH Grant/Contract)
DSIR 84-CTS

Details and patient eligibility

About

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.

Full 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

Enrollment

241 patients

Sex

All

Ages

8 to 14 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

241 participants in 2 patient groups

1
Experimental group
Description:
Family/Parents CBT (FCBT) for 14 to 16 weekly sessions
Treatment:
Behavioral: Family/Parents CBT
2
Active Comparator group
Description:
Peer/Group CBT (GCBT) for 14 to 16 weekly sessions
Treatment:
Behavioral: Peer/Group CBT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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