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

NCT01513915 | Completed DMC

• 1 other identifier: Parent CBT for Anxiety
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

parents; group cognitive behavioral intervention; anxiety disorder; children; FRIENDS program

Outcome Measures

Primary Outcomes (1)

• Revised Children's Manifest Anxiety (RCMA)

  This self report questionnaire consists of 28 items assessing a child's chronic or trait anxiety and 9 items assessing social desirability or potential lying. The RCMA has achieved a high internal consistency and moderate test-retest reliability.

  up to 30 minutes

Secondary Outcomes (6)

• Children's Depression Inventory (CDI)

  20 minutes

• Depression-Anxiety-Stress Scale (DASS)

  20 minutes

• Children Global Assessment Scale (CGAS)

  15 minutes

• Assessment of Consumer Satisfaction

  25 minutes

• Strengths and Difficulties Questionnaire (SDQ) Home Version

  [Time Frame: 30 minutes]

Study Arms (2)

A parent only group CBT

ACTIVE COMPARATOR

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.

Other: Group cognitive behavioral intervention

Waiting list group

NO INTERVENTION

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

Interventions

Group cognitive behavioral intervention 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.

A parent only group CBT

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• having DSM-IV criteria for a primary diagnosis of generalized anxiety disorder (GAD), separation anxiety disorder (SAD), social phobia, or specific phobia.
• age 6 to 12 years,
• 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,
• at least one parent willing to participate and give written consent.

You may not qualify if:

• diagnosed as bipolar disorder, autism spectrum disorders or mental disability by data obtained in personal history and clinical assessments,
• there was a change in drug regime during the study period,
• if parents missed more than 2 of 6 sessions of treatment.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Rouzbeh Hospital

Tehran, Tehran Province, 13333, Iran

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Zahra Shahrivar, MD

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: July 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 26, 2016

Record last verified: 2016-04

Locations

IR (1)