A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study

NCT ID: NCT01513915

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-07-31

Brief Summary

The fact that Cognitive Behavioral Therapy (CBT) is a well known efficacious intervention for children with anxiety disorders (AD) is undeniable. However, most children with AD have limited access to CBT. There is some controversial evidence on group CBT in AD involving families in treatment of their children and a published article on efficacy of a parent only group CBT for these children. Considering these data, the investigators hypothesized that teaching anxiety-fighting skills to parents of children with AD would diminish anxiety symptoms of both parents and children and improve family relational functioning.

Detailed Description

All children and their parents were interviewed using K-SADS-PL-Persian Version, a semi-structured diagnostic interview to confirm the diagnoses and assess possible comorbidities. All diagnostic assessments were conducted by a fellowship of child and adolescent psychiatry. Following assessment, once the participants reached twenty members, they were invited to complete child and parent self-report measures. The level of child functioning and family relationship functioning were also evaluated. Then they were randomly allocated to either parent training (N=20) or a 6 week wait-list (N=22) groups. During 2 weeks after treatment the assessments were repeated and satisfaction ratings were collected for the intervention group.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A parent only group CBT

There was a Group cognitive behavioral intervention -based on parent training component of "FRIENDS" program- for parents of children with anxiety disorders who were allocated to intervention group.

Group Type: ACTIVE_COMPARATOR

Group cognitive behavioral intervention

Intervention Type: OTHER

A Group cognitive behavioral intervention \_based on parent training component of FRIENDS program\_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.

Waiting list group

Parents of children with anxiety disorders who met the inclusion criteria and gave written informed consent and were allocated to wait list group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group cognitive behavioral intervention

A Group cognitive behavioral intervention \_based on parent training component of FRIENDS program\_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.

2. age 6 to 12 years,

3. receiving one of selective serotonin reuptake inhibitor (SSRI) medicine at the stable dose for at least 8 weeks before baseline assessments and during the study,

4. at least one parent willing to participate and give written consent.

Exclusion Criteria

1. diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,

2. there was a change in drug regime during the study period,

3. if parents missed more than 2 of 6 sessions of treatment.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Shahrivar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra Shahrivar, MD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

Rouzbeh Hospital

Tehran, Tehran Province, Iran

Countries

Iran

Other Identifiers

Parent CBT for Anxiety

Identifier Type: -

Identifier Source: org_study_id