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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01513915
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Zahra Shahrivar, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE January 16, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date April 26, 2016
Study Start Date  ICMJE July 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
Revised Children's Manifest Anxiety (RCMA) [ Time Frame: up to 30 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Revised Children's Manifest Anxiety (RCMA) [ Time Frame: up to 30 minutes ]
    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 ]
    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 ]
    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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2016)
  • Children's Depression Inventory (CDI) [ Time Frame: 20 minutes ]
    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 ]
    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 ]
    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 ]
    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
  • Strengths and Difficulties Questionnaire (SDQ) Home Version [ Time Frame: [Time Frame: 30 minutes] ]
    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: [Time Frame: 15 minutes] ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2012)
  • Children's Depression Inventory (CDI) [ Time Frame: 20 minutes ]
    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 ]
    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 ]
    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 ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
Official Title  ICMJE A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety Disorders
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • Active Comparator: 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.
    Intervention: Other: Group cognitive behavioral intervention
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2012)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513915
Other Study ID Numbers  ICMJE Parent CBT for Anxiety
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zahra Shahrivar, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zahra Shahrivar, MD Tehran University of Medical Sciences
PRS Account Tehran University of Medical Sciences
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP