Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zahra Shahrivar, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01513915
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Anxiety Disorders
Other: Group cognitive behavioral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Revised Children's Manifest Anxiety (RCMA) [ Time Frame: up to 30 minutes ] [ Designated as safety issue: No ]
    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.

  • Strengths and Difficulties Questionnaire (SDQ) Home Version [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    This questionnaire is a parent report of psychopathology in children and adolescents. The scale consists of 25 items which generates five subscale scores (Emotional Symptoms, Conduct Problems, Inattention/Hyperactivity, Peer Problems and Prosocial Behavior) and a Total Difficulties Score. We used the SDQ Emotional Symptoms Scale (SDQ-Em) as a parent measure of child anxiety. SDQ has adequate internal consistency (α=0.37) and good test-retest reliability (r=0.62).42-44 The validity and reliability of SDQ has been confirmed in community samples of Iranian children and adolescents

  • Global Relational Assessment of Functioning (GRAF) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    It provides a measure of the quality of functioning based on a review of three major areas: problem-solving, organization, and the emotional atmosphere. Available psychometric evidence suggests that clinician and even non clinician raters can achieve good to excellent reliability with only minimal training. The validity of the GRAF is supported by expected correlations with other measures of family and couple distress and functioning


Secondary Outcome Measures:
  • Children's Depression Inventory (CDI) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    This self report inventory has 27 items related to the cognitive, affective and behavioral signs of depression. The scale has high internal consistency and moderate test-retest reliability

  • Depression-Anxiety-Stress Scale (DASS) [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    This is a 42 item self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. The DASS was shown to possess satisfactory psychometric properties.45-47 Parents completed this scale about their own negative emotional states

  • Children Global Assessment Scale (CGAS) [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    This Scale was developed to be a more child-specific measure of functioning. This measure is currently used in diagnosis, treatment, and evaluation of children's mental health problems to determine eligibility to receive mental health services and document treatment outcome status

  • Assessment of Consumer Satisfaction [ Time Frame: 25 minutes ] [ Designated as safety issue: No ]
    Post treatment, parents in the intervention group completed a satisfaction questionnaire to rate how useful the program was in controlling their own anxiety, in managing their child anxious behavior, in improving family relations, the likelihood they would attend the treatment program again if needed, and if they would recommend the program to others on a 1 (not recommend) to 7 (highly recommend) likert scale


Enrollment: 40
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A parent only group CBT Other: Group cognitive behavioral intervention
A six 2 hour session group cognitive behavioral intervention was done based on FRIENDS program for parents of children with anxiety disorders.
No Intervention: Waiting list group
The waiting list group received the active intervention after the active treatment group.
Other: Group cognitive behavioral intervention
A six 2 hour session group cognitive behavioral intervention was done based on FRIENDS program for parents of children with anxiety disorders.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513915

Locations
Iran, Islamic Republic of
Rouzbeh Hospital
Tehran, Iran, Islamic Republic of, 13333
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Zahra Shahrivar, Assistant Professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01513915     History of Changes
Other Study ID Numbers: Parent CBT for Anxiety
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
parents
group cognitive behavioral intervention
anxiety disorder
children
FRIENDS program

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014