Completed

Therapy Specificity and Mediation in Family and Group CBT

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What is being tested

Peer/Group CBT

+ Family/Parents CBT

Behavioral
Who is being recruted

Anxiety Disorders

+ Mental Disorders

From 8 to 14 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2002
See protocol details

Summary

Principal SponsorFlorida International University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2002

Actual date on which the first participant was enrolled.

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

Official TitleTherapy Specificity and Mediation in Family and Group CBT 
NCT00073645
Principal SponsorFlorida International University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

241 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anxiety DisordersMental Disorders

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Peer/Group CBT (GCBT) for 14 to 16 weekly sessions

Group II

Experimental
Family/Parents CBT (FCBT) for 14 to 16 weekly sessions

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Florida International University

Miami, United StatesSee the location
CompletedOne Study Center