- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01513915
A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Group Study
April 23, 2016 updated by: Zahra Shahrivar, Tehran University of Medical Sciences
A Parent-only Group Cognitive Behavioral Intervention for Children With Anxiety Disorders: a Control Waiting List Group Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tehran, Iran, Islamic Republic of, 13333
- Rouzbeh Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Children's Manifest Anxiety (RCMA)
Time Frame: up to 30 minutes
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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.
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up to 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Depression Inventory (CDI)
Time Frame: 20 minutes
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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
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20 minutes
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Depression-Anxiety-Stress Scale (DASS)
Time Frame: 20 minutes
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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
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20 minutes
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Children Global Assessment Scale (CGAS)
Time Frame: 15 minutes
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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
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15 minutes
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Assessment of Consumer Satisfaction
Time Frame: 25 minutes
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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
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25 minutes
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Strengths and Difficulties Questionnaire (SDQ) Home Version
Time Frame: [Time Frame: 30 minutes]
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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
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[Time Frame: 30 minutes]
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Global Relational Assessment of Functioning (GRAF)
Time Frame: [Time Frame: 15 minutes]
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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
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[Time Frame: 15 minutes]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zahra Shahrivar, MD, Tehran University Of Medical Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
January 16, 2012
First Submitted That Met QC Criteria
January 19, 2012
First Posted (Estimate)
January 20, 2012
Study Record Updates
Last Update Posted (Estimate)
April 26, 2016
Last Update Submitted That Met QC Criteria
April 23, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Parent CBT for Anxiety
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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