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

Therapy Specificity and Mediation in Family and Group CBT

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00073645
Enrollment
241
Registered
2003-12-03
Start date
2002-07-31
Completion date
2008-07-31
Last updated
2013-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

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

Interventions

BEHAVIORALPeer/Group CBT

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

BEHAVIORALFamily/Parents CBT

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Florida International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
ADIS C/P Interference Rating Scales (Silverman & Albano, 1996)pre, post, and followup

Secondary

MeasureTime frame
Children's Manifest Anxiety Scale - Revised (RCMAS; Reynolds & Richmond, 1978) and Internalizing subscale of the Child Behavior Checklist (CBCL; Achenbach, 1991)pre, post, followup

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026